Help & Support

The Cue Health Monitoring System is designed to perform in vitro diagnostic testing and consists of the Cue Reader, Power Adaptor, and Charging Cable.

For additional information on how to use your Cue Health Monitoring System please refer to the Cue Health Monitoring System User Manual.

The Reader is an automated analyzer of test results and is used with the Cue Cartridges, Cue Wands, and the Cue Health Mobile Application (Cue Health App).

The Cue platform is turn-key and easy-to-use where user errors are mitigated significantly. The Cue Reader in conjunction with the Cue Health App ensures that the user performs the test correctly. The Cue Health App provides instructions and informs the user of any errors detected by the Reader to preclude inaccurate results.

Up to six (6) Cue Readers can connect to a compatible device. To connect additional Readers, follow the simple instructions below:

1. When logged into your Cue Account, access the “Dashboard” screen by tapping on the home button at the bottom of the screen.
2. Tap on “Manage Readers”.
3. Confirm that the BLUETOOTH wireless technology of your mobile device is enabled.
4. Tap on “+”.
5. Follow on-screen instructions to pair the additional Cue Reader. The Cue Reader is now paired to the mobile device.

Please see the Cue Health Monitoring System User Manual for further details.

Yes, the Reader can be transported repeatedly without revalidation. The Reader should not be moved while a test is in progress as it may cause automatic test cancelation.

The Reader needs to be on a flat level surface during the test. If tilted beyond 20 degrees during preheat, an error message will appear on the Cue Health App warning the user to return the Reader to a flat surface. If tilted beyond 20 degrees during the test, the test will cancel.

The Reader is cleaned by wiping the outside with a germicidal wipe. The Reader should be cleaned/disinfected after each use. Wipe with Clorox® Germicidal Wipes or equivalent (0.55% sodium hypochlorite).

Cue has partnered with the Biomedical Advance Research Development Authority (BARDA), a division of HHS since 2018, to develop the Cue Influenza Test. Cue has already started analytical and clinical validation for the at-home Influenza Test Cartridge.

The Reader has a one-year warranty. We have an internal technical support team. To contact us for technical support, email support@cuehealth.com or call us at 833.CUE.TEST (833.283.8378).

The Cartridge is a single-use, disposable unit that contains the reagents and associated materials required to convert test samples to digital results. The Cartridge works in conjunction with the Cue Wand and Cue Reader.

Yes, Cartridges expire. Cartridges may be used up until 11:59 PM UTC time the day before the Use By date printed on the Cartridge packaging. In some cases, Cartridges may be affected by a shelf-life extension, in which case the Cartridge may be used up until 11:59 PM UTC time the day before the extended Use By date as indicated by a Customer Notice of Shelf-Life Extension.

You may find the Use By date on the Cartridge box and on the label of the foil pouch containing your Cartridge. You may find any Customer Notices of Shelf-Life Extension in the Product Updates section of the test’s webpage.

For more information about Customer Notices, see our FAQ “What is a Customer Notice of Shelf-Life Extension?”

Cue Cartridge expiration dating is supported by ongoing cartridge stability studies. Cue intends to periodically update the expiration dating based on the stability demonstrated during the ongoing studies. In the event of a shelf-life extension, a Cue Health App update can allow for use of certain Cue Cartridges beyond the Use By date printed on the Cartridge packaging.

When Cue updates the expiration dating for certain Cartridge lots, a Customer Notice of Shelf-Life Extension will be issued to describe the Use By date extension and the Cartridges to which the extension applies. You may find any Customer Notices in the Product Updates section of the test’s webpage.

Unless a Customer Notice of Shelf-Life Extension has been issued, Cue Cartridges cannot be used after the Use By date listed on the Cartridge packaging. The Use By date is programmed into the Cartridge, which will prevent the test from being processed after the Use By date. In the event of a shelf-life extension, a Customer Notice of Shelf-Life Extension will be issued and a Cue Health App update will allow for use of certain Cue Cartridges beyond the Use By date printed on the Cartridge packaging. For more information about Customer Notices, see our FAQ “What is a Customer Notice of Shelf-Life Extension?”

In the event of a shelf-life extension, a Cue Health App update can allow for use of certain Cue Cartridges beyond the Use By date printed on the Cartridge packaging. When this occurs, a Customer Notice of Shelf-Life Extension will be issued indicating the extended Use By date and the Cartridges to which the extension applies. You may find any existing Customer Notices in the Product Updates section of the test’s webpage.

For more information about Customer Notices, see our FAQ “What is a Customer Notice of Shelf-Life Extension?”

The Cue Wand is a single-use, sterile, disposable swab used for collection of a nasal sample from the lower portion of the human nose. The Wand consists of a plastic handle and flocked tip. The flock fiber material, fiber adhesive, and Wand handle have been tested and validated to be biocompatible.

Cue External Control Swabs may be used to verify that a Cue test is working properly. Control Swabs are tested using the same procedure as for a patient sample.

No. It’s a simple lower nasal swab, which is pain free. The Cue Wand nasal swab is gently inserted one inch into each nostril vs. other methods such as nasopharyngeal swab which is more invasive.

The Cue Health App, which may be installed on the user’s compatible device, receives and displays test results from the Cue Reader. The Cue Health App allows users who have access to a Cue Health Monitoring System to register for individual accounts and receive the results of the test. The test results will be displayed automatically through the Cue Health App about twenty (20) minutes after the insertion of the Cue Wand into the Cartridge inside the Reader.

Results are transferred via Bluetooth from the Cue Reader to the Cue Health App that has been downloaded and installed on the user’s compatible device. Test results can be emailed or printed in a PDF format.

Visit our Compatible Devices page for a list of compatible devices and system requirements, and to download the Cue Health App. Use of devices other than those listed on the Cue website have not been validated and are considered “Off Label Use.”

For system requirements and to learn where the Cue Health App can be downloaded, visit our Compatible Devices page.

Authorized Laboratories
As required by applicable law, reporting is the responsibility of the administering Authorized Laboratory or the healthcare provider who orders the test or other entity operating under the supervision of the Authorized Laboratory. The Cue COVID-19 Test results may be printed and then manually entered into the electronic reporting system; Cue Health is not involved in that process. Authorized Laboratories may work with Cue Health to gain assistance for reporting; however, all reporting is the responsibility of the Authorized Laboratory or the healthcare provider who orders the test or other entity operating under the supervision of the Authorized Laboratory.

Over the Counter
When consumers use the Cue COVID-19 Test for Home and Over The Counter (OTC) Use, automatic test result reporting will be performed by Cue Health using the Cue Health App and the Cue Health secure cloud server. This helps public health efforts to monitor if and where COVID-19 is spreading. The information shared with public health agencies is not linked to your name.

Not at this time; however, all of the test data goes into our HIPAA compliant backend database. We are working on developing APIs to connect our backend to a customer’s EMR or LIS.

Not at this time. However, we are planning to implement Single Sign On in the near future.

Cue Care is an easy, convenient way to get medically indicated prescribed medication through a Cue Care virtual consultation with a qualified health provider. Here are just a few of the reasons to use Cue Care:

Fast: Same-day delivery in 50 states. (Note: delivery times vary and are based on market/availability)*

Convenient: Access Cue Care via your mobile device.

Accessible: Cue Care is available to anyone 18 years of age or older with a diagnosis for a condition that has an applicable Cue Care treatment. Cue Care offers certain treatments that may be available to minors 12 years of age or older with adult consent and supervision. Treatments are FDA approved.

Cost Effective: Combined, the virtual clinical consultation and same-day prescription delivery is less than $100 – cost of prescription not included.

Benefits the Community: Helps people get the treatment they need in a timely manner from the comfort of home and in cases of easily transmitted infectious diseases, minimizes potential exposure to others in the case of infectious viruses.

*Depending on the time and day the order is received, availability of medication, and the market where you live, delivery may take up to 24 hours.

Cue Care is a seamless 5-step process that shouldn’t take more than 30 minutes (not including test time or delivery time) and your treatment, if prescribed, will be delivered the same day.

If you test positive for a condition with an available Cue Care treatment:

1. From the Cue Health App, select the type of treatment you are seeking.
2. Select a pharmacy for pick-up or enter a delivery address.
3. Answer a few short questions about your health and prepare for your telehealth consultation.
4. Join your telehealth consultation with your Cue Care clinician and get your treatment plan.
5. Get your medication, if prescribed, delivered to your home within hours.*

You do not need to use a Cue test to access Cue Care. If you use a third-party test (e.g. a COVID-19 antigen test), you will be asked to upload a picture of your results next to your government-issued ID to access the service.

*Medication requires prescription and is subject to availability.

If you test positive for COVID-19 using a non-Cue test, the only documentation required is a photo of your government-issued ID next to your positive test. You will be asked to upload this in Cue Health App.

The cost for Cue Care services is $79 for Cue+^™ Members and $99 for non-members.

Patients that opt-in to purchase Cue Care are charged a flat fee that covers costs associated with the telehealth visit, submission of the e-prescription, if provided, and the delivery of the medication. It does not include the cost of the medication, which may or may not be covered by your health insurance. Please contact your insurer for questions about coverage and reimbursement.

Many prescription medications are covered by insurance. While we are proactively working with health insurance companies to get coverage for Cue Care, patients will need to work directly with their insurer on all reimbursement questions.

The Cue Health App provides documentation for all Cue tests taken under a specific account and medications prescribed through a Cue Care clinician.

What about HSA or FSA accounts?
All products in the Cue shop can be purchased with HSA/FSA accounts.

How do I request a detailed price breakdown for insurance purposes?You may request a detailed price breakdown after the completion of your telehealth service by emailing Cue Care Customer Service at support@cuehealth.com.

Yes! While you don’t have to be a Cue+^™ Member to access Cue Care^™, members will receive preferred pricing on the service. Learn more about Cue+ Membership.

You don’t have to use a Cue test to access treatment either. Cue Care is available to those who use either a Cue test or a third-party test, e.g. a COVID-19 antigen test.

If a telehealth clinician issues an e-prescription for you through Cue Care^™, we then work to fill it and deliver it to you, which is usually within 24 hours.

If your telehealth clinician submits an e-prescription before 4pm local time Monday through Friday or by 12pm on Saturday or Sunday, you will receive your delivery on the same day. If the submission for the e-prescription delivery is placed after 4pm Monday through Friday or after 12pm on Saturday or Sunday, you should receive your delivery the next day. If it’s a holiday, your order will be delivered the next day.

Depending on the time and day the order was received, availability of medication, and the market where you live, it may take up to 24 hours.

Clinicians who provide telehealth consultations through Cue Care are not Cue employees. We partner with a clinician network that includes board-certified physicians and nurse practitioners with years of experience in primary care, family medicine, and internal medicine. They’re committed to delivering the highest-quality patient care and specialize in virtual care.

Cue Care complies with HIPAA’s strict technical, physical, and administrative security safeguards and standards.

We do not sell customers’ personal or health information to third parties.

We conduct thorough due diligence on the third parties we work with, and our relationships with them are protected through legally binding contracts which also address security and privacy.

Please see our Privacy Policy for more information on how we manage your test results and data.

The Cue Care^™ fee includes consultation with the clinician and e-prescription if appropriate. Before paying for the service, you will be prompted in the Cue Health App to answer a few short questions that are designed to better understand your eligibility for treatment.

If your answers suggest that you are not eligible for treatment, the Cue Health App will allow you the opportunity to cancel the request before the telehealth consultation with a clinician begins.

A summary of your Cue Care session will be made available through the Cue Health App to share with anyone you choose.

Yes, you can still use Cue Care to get treatment if you use a third party test. Treatment eligibility will be determined by a clinician during a virtual visit.

You will need to upload an image of your test results and government-issued photo ID in the Cue Health App to begin the process.

Our goal is to provide Cue Care to as many people as possible to improve health outcomes for the largest number of people.

According to the US Department of Health and Human Services (HHS), early treatment for eligible patients can help improve health outcomes, reduce stress on healthcare facilities, and even save lives.

If you test positive for COVID-19 and are more likely to get very sick, treatments, including antivirals, are available that can help improve your health outcomes and make hospitalization less likely. Treatment must be started within 5 days after you first develop symptoms to be effective.

The telehealth clinicians within Cue Care can provide more information and answer any specific questions you might have.

Before you’re connected with a telehealth clinician, you will be required to fill out a health questionnaire, capturing key information that will help inform the course of care recommended by your telehealth clinician.

The telehealth clinician will have this information at the time of your conversation. After your session with the telehealth clinician, we recommend you follow up with your own physician, to ensure continuity of care.

To review FDA’s guidance on this, please see the FDA’s information on authorized treatments for COVID-19.

That’s a question best handled by a clinician. Clinicians within Cue Care^™ are able to answer the questions you might have about the medication and whether it’s right for you.

Review FDA’s information on authorized treatments for COVID-19.

There are medications that could potentially interact with a COVID-19 antiviral medication, such as Paxlovid. Users will be asked to discuss their medical history and the medications they are currently taking, so that the virtual care clinician can consider these factors when determining the right treatment.

Virtual care clinicians will use their clinical expertise and resources to determine if any medications could potentially interact with the COVID-19 antiviral.

Based on this information, a virtual care clinician may need to instruct a patient to adjust their medication dosage or hold their medication for a period of time.

However, there are some medications that cannot safely be adjusted by the virtual care clinician and in that case, the clinician may need to refer a patient back to their in-person provider.

Review FDA’s information on authorized treatments for COVID-19.

For informational purposes only. Cue Health is not affiliated with Paxlovid, molnupiravir and any other drugs mentioned.

This personal healthcare decision will be based on a consultation with a telehealth clinician.

We encourage you to speak with a clinician regarding your COVID-19 treatment. Clinicians within Cue Care^™ are able to answer the questions you might have about antiviral medications and whether they are right for you.

Cue Care includes a virtual care visit with a qualified health provider who will help determine if treatment is right for you, as well as prescription treatment and delivery when appropriate. Must be 12 years or older to use Cue Care. Minor children (ages 12-17) must be accompanied by a parent or guardian with a Cue Health account who is authorized to consent on behalf of the child. This service does not address life-threatening conditions. In case of an emergency, please call 911.

Yes! Cue Care is also available to those who test positive for COVID-19 with an antigen or lab test. You will need to upload an image of your test results and government-issued photo ID to begin the process.

Our goal is to provide Cue Care to anyone who tests positive for COVID-19 on any test, to improve health outcomes for the largest number of people possible.

The Cue Dashboard is a secure, centralized, web-based application for businesses and organizations to manage their Cue testing program efficiently and effectively to guide decision-making. Whether you are a small business or a large organization, the Dashboard can be customized to integrate seamlessly with your business systems, aggregate and analyze information from multiple sources within your organization, and streamline reporting and communications.

The Cue Dashboard includes:

• Scheduler for testing events within your organization
• Ability to manage multiple test locations from one centralized portal
• Test Center to view and manage test results in real time, categories of members, and data visualization to swiftly identify trends
• Capability to import individuals or bulk lists of members, and to view and manage categories of members
• Ability to view and manage roles and permissions for your dashboard
• Integration with HL7 systems to view and manage work orders
• Access to message templates

There are several different tiers of service available within the Cue Dashboard, some of which come at an additional cost. We encourage you to reach out to our team to learn more about what’s included in each tier and how the Dashboard may benefit your organization.

The Cue Dashboard features end-to-end data encryption and is compliant with HIPAA (Health Insurance Portability and Accountability Act of 1996) and other federal privacy regulations.

The Cue Dashboard is designed to be easily customized to meet your organization’s needs. The Cue Dashboard can integrate into your existing system through our secure application programming interface (API) or health level seven (HL7) using a virtual private network (VPN).

The Cue Dashboard and the Cue Health App are separate systems. The Cue Dashboard synchronizes with the Cue Health App, providing easy-to-interpret data based on results throughout your organization. To access the Dashboard, you will need a laptop or desktop. The Cue Health App is accessible through a mobile smart device.

By selecting CLIA in the Cue Health App, your user type in the Cue Dashboard will be defined as a Professional User associated with a CLIA-certified laboratory (instead of a consumer at-home or enterprise user). Dashboard accessibility and experience is the same for both user types.

No. Test results cannot be deleted from the Cue Dashboard.

You can buy any at-home test kit on our website or in the Cue Health App. After registering your kit and collecting your sample, place it in the included prepaid return shipping envelope and drop your package off at a USPS mailbox, drop-box or Post Office. In most circumstances, your results will be ready within 3-5 business days after the lab receives your sample. You'll receive a push notification, email, and/or text once you can securely review your results in the Cue Health App. If you have questions about your test or want to discuss your results, you can use the Cue Health App to access on-demand virtual care and prescription delivery for eligible conditions.

You’ll need to register your at-home test kit in the Cue Health App (version 1.16 or newer) before collecting your sample. Get started by downloading the App in the App Store or Google Play. If you already have the Cue Health App, please ensure you’ve installed the latest version (1.16 or newer). Log in and follow step-by-step instructions within your app, or scan the QR code on the packaging of your test to register your kit. Once registered, you are ready to collect your sample. We recommend shipping your sample to the lab on the same day that you collect it.

You must register your at-home test kit within 60 days of receiving it in the mail. If you do not register your kit within this window, your test will expire. The sample you collect with your at-home test kit must be mailed within 90 days of receiving your kit. If your sample is not mailed within this window, your test will expire. Expired at-home test kits will not be refunded or replaced. If you have trouble registering your kit or mailing your sample, please reach customer support from the Cue Health App. You may also contact support@cuehealth.com or 1(833)-CUE-TEST.

Yes. You’ll need to register your at-home test kit in the Cue Health App (1.16 or newer) before collecting your sample. Get started by downloading the App in the App Store or Google Play. If you already have the Cue Health App, please ensure you’ve installed the latest version (1.16 or newer). Log in and follow step-by-step instructions within your app, or scan the QR code on the packaging of your test to register your kit. Once your kit is registered, you are ready to collect your sample. We recommend shipping your sample to the lab on the same day that you collect it.

You must register your at-home test kit within 60 days of receiving it in the mail. If you do not register your kit within this window, your test will expire. The sample you collect with your at-home test kit must be mailed within 90 days of receiving your kit. If your sample is not mailed within this window, your test will expire. Expired at-home test kits will not be refunded or replaced. If you have trouble registering your kit or mailing your sample, please reach customer support from the Cue Health App. You may also contact support@cuehealth.com or 1(833)-CUE-TEST.

Please ensure you’ve installed the latest version of the Cue Health App (version 1.16 or newer). If you are still having trouble registering your kit, please reach customer support from the Cue Health App. You may also contact support@cuehealth.com or 1(833)-CUE-TEST.

You must be age 18 or older to use Cue’s at-home test kits. Some tests are restricted by sex assigned at birth. Due to state restrictions, Cue's at-home test kits are not available to residents of New York. Other restrictions may apply to at-home test kits and to Cue Care treatment services for some tests. Check your specific test for eligibility requirements.

Your at-home test kit includes a prepaid return shipping envelope. After collecting your sample, follow the instructions provided with your kit or as demonstrated on the Cue Health App. You'll receive a push notification, email, and/or text once you can securely review your results in the Cue Health App.

In most circumstances, your results will be ready within 3-5 business days of the lab receiving your sample. You'll receive a push notification, email, and/or text once you can securely review your results in the Cue Health App. If your order is delayed due to unforeseen circumstances, our customer service team will reach out to you.

Federal holidays may cause shipping and laboratory delays. These holidays include:

• New Year’s Day
• Memorial Day
• Independence Day
• Labor Day
• Thanksgiving
• Friday after Thanksgiving
• Christmas Day

Each diagnostic test kit includes detailed instructions that help you properly collect and handle your sample. If your results are invalid or you want to repeat your test, please contact customer support at 1 (833) 283-8378 or email support@cuehealth.com.

Once your sample has been processed and results are available, you can view your results using the Cue Health App. You can download the Cue Health App on the App Store or Google Play Store

Yes. Once your results are ready, we'll send you a notification, email, or text to view them in Cue Health App.

Due to state restrictions, Cue mail-in lab tests are not available to residents of New York. Additionally, the Colon Cancer Screening, the Women’s Sexual Health Panel, and the Men’s Sexual Health Panel is not available to residents of New Jersey, New York, and Rhode Island. These restrictions do not apply to Cue’s COVID-19 test.

Cue tests are not currently covered by insurance, but we are actively working with health insurance companies to get coverage for some Cue Health solutions. However, many Cue tests are FSA/HSA eligible, which means that your health benefits may be able to cover Cue. We recommend connecting with your insurance provider directly to inquire more about their policies and your plan. We work hard to keep our pricing accessible, and in most cases, the price of a test is similar to the out-of-pocket costs for testing in a clinical setting.

We recommend connecting with your insurance provider directly to inquire more about their policies and if your plan provides coverage. We work hard to keep our pricing accessible, and in most cases, the price of your test is similar to out-of-pocket costs for testing in a clinical setting.

Yes. You won't have to pay extra to send your sample to the lab. A prepaid return shipping label will be provided with your at-home test kit.

No. You must ship your sample to the address printed on your provided return shipping label. The laboratories we partner with to process Cue tests are CLIA-certified and CAP-accredited, which means they meet the highest standards for pathology and laboratory medicine.

If you want to discuss your results or get prescription delivery of treatment if indicated, you can join a video chat with a virtual care provider by selecting the Cue Care™ option in your Cue Health App. If you test positive for certain conditions with a Cue test, you can consult a clinician with Cue Care™ services at no extra cost. Cue Care also includes delivery of prescribed medicines to your home at no extra cost. This service is only available at participating pharmacies. Check your selected pharmacy to see if it supports at-home delivery. Please check the Cue Health App or our Cue Care FAQs for more information on conditions that are treatable with a Cue Care session.

We do not automatically share your test results with anyone; however, you can use the Cue Health App to securely share health information with your provider.

You may request a detailed price breakdown after the completion of your telehealth service by emailing Cue Customer Service at support@cuehealth.com.

Cue Health cannot accept returned/unused test kits, please dispose of the kit if you no longer wish to use it.

If your test is not registered and within the 60-day registration window: You are eligible for a full refund less shipping fees and $25 USD per test kit to cover the cost of the sample collection kit and processing fees. To start the refund process, send an email to our customer service (with your order number) at support@cuehealth.com.

If your test is not registered and past the 60-day registration window: You are not eligible for a refund.

If your test is registered: You are not eligible for a refund.

For details on registering your at-home test kit, please read our answer to “Do I need to register my test kit?”.

Yes. Cue+ Membership includes up to a 20% discount off* most Cue products and services, including on-demand access to in-app messaging with healthcare providers, virtual telehealth services, certified test results for travel, work, and school, and e-prescription services.

*Exclusions may apply to the discount.

Due to state restrictions, prescription medications are not currently available in the following states: Alabama, Delaware, District of Columbia, Idaho, Kansas, Kentucky, Louisiana, Mississippi, New Mexico, and West Virginia. This list is subject to change.

We are committed to providing you with safe and effective healthcare solutions. Cue only offers FDA-approved or authorized medications, but it is important to understand that every medication comes with inherent risks that may vary depending on your health history. Answer the health questions in your medical questionnaire thoroughly. Also, review your treatment plan and potential side effects before you start using the medication. During treatment, follow instructions in your information packet and closely monitor your body's response to the medication. You should discuss any concerning side effects with your healthcare provider.

Generally, there's no major difference between name-brand medications and their generic versions. They have the same active ingredients and work the same way in your body. The major differences are usually in available dosage and price.

These treatments are not currently covered by insurance, but we are actively working with health insurance companies to get coverage for Cue Health solutions. However, many medications are FSA/HSA eligible, which means that your health benefits may be able to cover them. We recommend connecting with your insurance provider directly to inquire more about their policies and your plan.

No, you do not need a prescription to use this treatment. However, please read the 'What you should know' section above and consult with a clinician if you have potential allergies, contraindications, or questions.

At this time, we are unable to accept outside prescriptions. If your healthcare provider has already written a prescription for you, you will still have to complete a medical questionnaire and get approval from a clinician in our network.

To order your medication, go to the product page on shop.cuehealth.com and choose your preferred strength, monthly quantity, and how many months you'd like to receive medication for. After clicking Order Now, if you are requesting a prescription medication, you’ll need to fill out a medical questionnaire to have your request approved by a healthcare provider. Once approved, your medication will be shipped to you, or will be available for pickup at your selected pharmacy.

We understand that determining which medication strength and dosage to request can be difficult. To help you make the right choice, you can find information on each product page by hovering over the “i” icon next to each selection. Here, you’ll see medication strengths and the most popular options.

If you're still unsure, select the "Choose for me" option and the most prescribed medication strengths, quantity, and supply will be selected for you to add to your cart. If you are purchasing a prescription medication, you will then be prompted to complete a medical questionnaire for clinician approval. After a clinician reviews your request, they may recommend a different dosage. You will simply approve that new order and your medication will be shipped.

You do not need to download the Cue Health App to order your medications. You can complete your order and medical questionnaire (required for prescription requests), and consult with a clinician all on the Cue Health website. However, if you need to approve an adjusted order, or want to manage your subscriptions, you will need to download the Cue Health App. You will also need to download the app if you purchased an at-home test. In the app, you can conveniently register your test kit, access results, manage subscriptions, and more.

If your prescription request is not approved, a note from your clinician will be provided within the order details section in the Cue Health App. The note will explain why your request was not approved and provide additional guidance on next steps. From there, you may be able to request a new prescription.

If your clinician has no questions or concerns about your request, your prescription may be approved in as quickly as 24 hours. However, your request may take several days to process if your clinician has any outstanding questions. This helps ensure you receive a safe and effective treatment plan aligned with your health needs.

Once you have placed your order, you’ll be asked to complete a medical questionnaire (only necessary with prescription medication orders). Your clinician will review your request and medical history, and approve your order if your selection is right for you. If your clinician has any questions, they will reach out to you through a text-based chat within the website portal or the Cue Health App.

While we do not currently allow updates to your completed questionnaire, we encourage you to communicate any corrections or concerns with your clinician.

These treatments are not currently covered by insurance, but we are actively working with health insurance companies to get coverage for Cue Health solutions. However, many medications are FSA/HSA eligible, which means that your health benefits may be able to cover them. We recommend connecting with your insurance provider directly to inquire about their policies and your plan.

When you place an order for medication on our website, an independent board-certified nurse practitioner or physician will review your request and medical questionnaire for approval. You will be able to initiate a text-based chat with a clinician during this process. If, after your approval and order is complete, you have general healthcare questions or concerns, you can also speak to a clinician by using the Cue Health App. Simply select "General Visit" in the Care section of the app to get started. Our clinicians are available on-demand to provide guidance and support whenever you need it.

We take great care in selecting only independent, licensed, board-certified physicians and nurse practitioners to be part of our network of clinicians.

We currently do not offer subscriptions for less than 3 months.

Once your request is approved, your order will be fulfilled. Shipping times vary depending on your location and the shipping method you've selected and typically range from 3-5 business days after being processed.

Your delivery will come in a discreet, non-branded mailing envelope or box.

If your treatment doesn’t help or it causes side effects that concern you, talk to a healthcare provider. Your clinician may change your dosage depending on your health and symptoms.

If you are looking to refill or renew a prescription, you will need to place a new order and go through the process with a clinician review prior to approval.

You can pause, skip, or cancel your subscription to a medication under My Treatments in the Cue Health App. Please note that you will need to do this before processing of the shipment begins or your order will be shipped to you as scheduled.

No. All medications are non-refundable.

Like most products, these treatments do have a shelf life. Be sure to check the expiration date on your packaging before using your treatment.

UTIs don't always cause symptoms. When they do, they may include:

• A strong urge to urinate that doesn't go away
• A burning feeling when urinating
• Urinating often, and passing small amounts of urine
• Urine that looks cloudy
• Urine that appears red, bright pink or cola-colored — signs of blood in the urine
• Strong-smelling urine
• Pelvic pain, in women — especially in the center of the pelvis and around the area of the pubic bone

Getting the necessary treatment for a UTI through Cue Care is fast and easy.

To get started, you’ll need a positive UTI test result from a third party or the Cue Health App. If you don’t have a test, you can order one here. To download the Cue Health App, go to the App Store or the Google Play Store on your mobile device.

Once you have those two things, the process is as follows:

1. Open Cue Health App, navigate to the Cue Care section, and select the UTI treatment option.
2. Upload a photo of the positive test result which should include your first and last name, the date the specimen was collected, and a positive result. If your name is not on the test, place your government-issued photo ID next to your result, take a photo, and upload it.
3. Fill out personal information, select a pharmacy, and choose your pick-up or delivery option.
4. Complete the intake questionnaire.
5. Speak to a healthcare provider over video and discuss a treatment plan.
6. Medicine will be delivered to you or available for pick-up the same day, if prescribed.

Same-day delivery for prescription orders received before 4pm Monday through Friday or 12pm Saturday through Sunday (local time zones). Orders placed after these times will be delivered the next day. Some exceptions may apply, depending on location and medication availability. Same-day delivery is not offered on the following holidays: Labor Day, Thanksgiving, Christmas Eve, Christmas Day, and New Year’s Day.

No, at this time only the prescription medication is being offered via Cue Care. The UTI test strips can be ordered from the Cue Health Shop (via the Cue Health App or shop.cuehealth.com) just like the Cue Reader and Test cartridges. Depending on where you live and the type of shipping selected, they will arrive in approximately 1-3 days.

If your infection is caused by bacteria, you may be prescribed an antibiotic. However, the type of medication you are prescribed (if deemed necessary) will be at the discretion of your clinician. If you have questions about the treatment you are prescribed, please ask your clinician.

For most simple UTI cases, a short course of antibiotics, 1-3 days, may be required. For more complicated UTIs, a longer course of antibiotics of up to 2 weeks may be necessary.

Your clinician will decide the best course of treatment for you depending on your specific condition and medical history.

UTI treatment through Cue Care is currently being offered to women in the U.S. who are 18 to 65 years of age.

No, you do not need a Cue Reader or a Cue test to access UTI treatment through Cue Care. Any UTI test will work, and all you need to do is upload a picture of your results alongside your government-issued photo ID.

If you need a UTI test, you can buy one in our online shop. No Cue Reader is needed.

Influenza (also known as flu) can cause mild to severe illness. People who have flu often feel some or all of these symptoms:

• fever or feeling feverish/chills
• cough
• sore throat
• runny or stuffy nose
• muscle or body aches
• headaches
• fatigue (tiredness)
• vomiting or diarrhea, though this is more common in children than adults

With Cue Care, it’s fast and convenient to receive treatment for flu. Get started by downloading the Cue Health App on the App Store or Google Play Store. Once you’ve created an account or logged in, you can access treatment by following these easy steps:

1. Open Cue Health App, navigate to the Cue Care section, and select the flu treatment option.
2. Take or upload a photo of your results next to your government-issued ID. You must have a positive test within the last two days to receive treatment.
3. Fill out personal information, select a pharmacy, and choose your pick-up or delivery option.
4. Complete the intake questionnaire.
5. Speak to a healthcare provider over video and discuss a treatment plan.
6. Medicine will be delivered to you or available for pick-up the same day, if prescribed.

If you have a viral infection, you may be prescribed an antiviral; however, the type of medication you are prescribed (if deemed necessary) is at the discretion of your clinician. If you have questions about your treatment, please ask your clinician.

The amount of time you should take flu medication for will depend on your treatment plan; however, antiviral drugs that treat flu are usually taken for five days. If you have questions about your treatment, please ask your clinician.

Flu treatment services through Cue Care are available to anyone in the U.S. between the ages of 18 to 65.

No, you do not need a Cue Reader or a Cue test to access flu treatment services through Cue Care. All flu test results are accepted. Just upload a picture of your positive flu test results alongside your government-issued photo ID.

No. Cue is a manufacturer of the tests and does not administer them.

To learn who can administer each Cue test, please reference the Product Documentation for the test you are interested in.

Cue is the device manufacturer. A customer is the person or entity who purchases the tests. A customer may, in some cases, also be an Authorized Laboratory. For example, a hospital would likely be both an Authorized Laboratory and a customer because the hospital would both purchase and administer the tests. Depending on the usage guidelines of a particular test, an Authorized Laboratory may or may not be required to administer the test.

To learn who can administer each Cue test, please reference Product Documentation for the test you are interested in.

Laboratories with a CLIA Certification
Under CLIA, a laboratory is defined as a facility that performs applicable testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings. The labs are CLIA certified by CMS acting through the states.

Point-of-Care Settings with a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
Point-of-care includes settings such as hospital rooms, physician offices, urgent care, outreach clinics, pharmacies, and temporary patient care settings that have appropriately trained personnel to perform the test and are operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

If an entity has the appropriate CLIA certificates and follows applicable CLIA regulations, state regulations, and guidelines, a laboratory’s CLIA certificate can be extended to cover testing in areas outside of the designated primary site such as contiguous buildings, or any other designated temporary overflow location in its facility or temporary remote location, such as a parking lot. CMS also defines temporary testing sites to include mobile units.

Further, CMS requires applicants for a CLIA Certificate of Waiver to identify as to their type of testing entity on the CLIA application. Please note that these entities may include healthcare providers, HMOs, and other settings, including school/student health services and practitioners. In addition to healthcare providers and ancillary sites, a CLIA Certificate of Waiver can be obtained for health fairs, by independent or industrial organizations, insurance organizations, mobile laboratories, pharmacies, and school/student health services.

CLIA Waiver Certificates may be obtained by submitting the application form (CMS-116, CLIA Application Form) to the state where the laboratory is located. The state contacts for submission are indicated in a document issued by CMS at this link: https://www.cms.gov/files/document/qso-20-21-clia.pdf-0.

This CMS document indicates that once the laboratory has identified a qualified laboratory director and has provided all required information on the CMS-116 application, a CLIA number will be assigned and the laboratory can then begin testing as long as the applicable CLIA requirements have been met.

Pooling is the process of combining multiple swabs in one viral transport media (VTM) sample. It can save time and resources. If the pool result is Positive, individuals included in the pool need to return for repeat testing.

The Cue COVID-19 test is a fast, lab-quality molecular test. Specifically, it has been authorized by the Federal Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) for the detection of nucleic acid from SARS-CoV-2. The Cue COVID-19 test is conducted using the Cue Health Monitoring System, the Cue COVID-19 Cartridge, and the Cue Health App.

Both Cue’s COVID-19 test and laboratory tests (commonly known as PCR) are molecular nucleic acid amplification tests (NAAT) that detect the SARS-CoV-2 virus genetic material. Other types of molecular tests are PCR, RT-PCR, and LAMP. Molecular tests are more accurate than other methods such as antigen tests. The Cue COVID-19 test uses isothermal nucleic acid amplification technology for the molecular amplification reaction that is an equivalent alternative amplification method to polymerase chain reaction (PCR).

For information on how the Cue COVID-19 test is performed, please visit Product Documentation and refer to the Quick Reference Instructions (QRI) and the Instructions For Use (IFU).

You can find more information about the Cue COVID-19 test here.

The Cartridge is a single-use, disposable unit that contains the reagents and associated materials required for detection of the SARS-CoV-2 virus in direct nasal swabs, or in previously collected nasal specimens in viral transport media from individuals who are suspected of having COVID-19 by their healthcare provider.

The Cue COVID-19 Test for Professional Use and the Cue COVID-19 Test for Home and Over The Counter (OTC) Use are identical except for their respective FDA Emergency Use Authorizations. There is no form or technological difference between the tests except for who is authorized to purchase and administer the tests, the product labeling differences required by those authorizations, and the in-app experience related to each test.

The Cue COVID-19 Test for Professional Use may be purchased and administered by Authorized Laboratories.

The Cue COVID-19 Test for Home/OTC Use may be purchased and self-administered (or administered with adult assistance for ages 2 and up) by individual consumers without a prescription.

To learn more about who can administer each test, please reference the Product Documentation for the test you are interested in.

The Cue COVID-19 test detects the genetic material (nucleic acid/RNA) of the SARS CoV-2 virus, which causes COVID-19.

A molecular test detects the presence of virus genetic material (SARS-CoV-2 RNA). Molecular tests determine if you have a current infection.

An antigen test detects specific proteins on the surface of the SARS-CoV-2 virus. Antigen tests also determine if you have a current infection, but antigen tests are generally less sensitive than molecular tests.

An antibody test detects the presence of antibodies to the SARS-CoV-2 virus, which reflects the body’s immune response. Antibody tests determine if you had a past infection of COVID-19.

No, Cue has not established a particular time window when the Cue COVID-19 test is most accurate. Generally, molecular tests are most accurate during the acute phase of infection.

All studies required by the FDA were performed and are reported in the Instructions For Use (IFU) for each COVID-19 test. You can find these IFUs in the Product Documentation for each test.

Yes. Mutations of the genome are inherent to the virus replication cycle.

Yes. The Cue COVID-19 Test for CLIA-Certified Healthcare Providers and Laboratories, Cue COVID-19 Test for Home and Over The Counter Use, and Cue COVID-19 Molecular Test can detect variants and subvariants of concern, such as BA.2.86, EG.5, XBB, and other prevalent variants of concern. Like other COVID-19 viral diagnostic tests, Cue’s test cannot specify which variant has been detected. The test will only indicate if your result is positive or negative for the SARS-CoV-2 virus.

Our scientists have found that the performance of Cue’s COVID-19 tests is not impacted by and can detect known variants and subvariants of concern, including prevalent Omicron subvariants. For example, the primers used in Cue’s COVID-19 tests are a 100% match with emerging subvariant BA.2.86.

Since the start of the pandemic, Cue’s team of scientists and bioinformatic experts have actively monitored the genomic sequences of the virus as the virus changes, or mutates, over time. Using the GISAID database, Cue scientists analyze all variants that have 5% or higher prevalence and that have increased in prevalence within the last 30 to 60 days.

The scientists compare the genomic sequences of the variants with the sequences in Cue’s COVID-19 test primers to confirm that the test remains highly sensitive to SARS-CoV-2 genetic material. None of the mutations reported thus far have affected the sensitivity of Cue’s COVID-19 test.

GISAID is a global science initiative and primary source database that curates and provides access to genomic data of the coronavirus responsible for the COVID-19 pandemic. It is constantly updated by scientists worldwide to follow variants and trends of the virus and its mutations.

Cue’s COVID-19 test does not provide information about specific variants. The test will only indicate if your test result is positive or negative for the SARS-CoV-2 virus.

Cue continues to explore opportunities to provide innovative products to protect or improve public health. To stay informed about Cue’s advancements, visit www.cuehealth.com periodically, sign up to receive email updates, or follow us on Twitter.

The Cue COVID-19 Cartridge is inserted into the Cue Reader to preheat. The user of the test collects a nasal swab from the lower portion of both nostrils using the included Cue Wand, and inserts it into the pre-heated Cartridge. The Cartridge and Reader work together to complete the test and communicate the progress and results in about 20 minutes to a compatible device that is running the Cue Health App.

Cue Cartridges must remain at room temperature. For more details, please reference the Instructions for Use (IFU) for your specific Cue COVID-19 test.

The Cue COVID-19 Test for Home and Over The Counter (OTC) Use

The Cue OTC Test is authorized for nonprescription home use and may be used in adults (self-swabbing) or children ≥2 years of age (swabbed by an adult) with or without symptoms or other epidemiological reasons to suspect COVID-19.

Cue COVID-19 Test for CLIA Certified Healthcare Providers and Laboratories

The Cue COVID-19 Test administered by professionals may be used for individuals with or without symptoms or other epidemiological reasons to suspect COVID-19.

A molecular test detects the presence of virus genetic material (SARS-CoV-2 RNA). Molecular tests determine if you have a current infection.

An antigen test detects specific proteins on the surface of the SARS-CoV-2 virus. Antigen tests also determine if you have a current infection, but are generally less sensitive than molecular tests.

Antigen tests have a higher chance of missing an active infection. If an antigen test shows a negative result indicating that you do not have an active COVID-19 infection, your healthcare provider may order a molecular test to confirm the result.

Please contact Cue to check on availability: https://www.cuehealth.com/contact/sales.

Yes, the Cue COVID-19 Test for Home and Over the Counter (OTC) Use was granted Emergency Use Authorization from the FDA for use with symptomatic and asymptomatic individuals ages 2 and older. Tests may be purchased and self-administered (or administered on a minor with adult assistance) in non-clinical settings by individual consumers without a prescription.

Currently, the Cue COVID-19 test is only distributing within the U.S. and its territories. To stay up to date on Cue's availability, submit an inquiry or subscribe to our newsletter.

Cue COVID-19 Molecular Test
In June, FDA cleared Cue’s COVID-19 test through the De Novo classification process. The Cue COVID-19 Molecular Test underwent additional strict regulatory reviews to ensure that the test meets the FDA’s stringent regulatory standards for safety and efficacy outside of the emergency use authorization state. The Cue COVID-19 Molecular Test is available without a prescription and can be used by individuals 18 years of age and older with signs and symptoms of COVID-19. The test will become the standard for new products of its kind.

Cue COVID-19 Test for CLIA Certified Healthcare Providers and Laboratories
The Cue COVID-19 Test for Professional Use was granted Emergency Use Authorization (EUA) from the FDA for the detection of nucleic acid from SARS-CoV-2. The Cue COVID-19 Test may be used to test symptomatic and asymptomatic individuals. Testing may be performed by CLIA certified laboratories or at the point-of-care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
The Cue COVID-19 Test has also received the CE Mark authorizing it for sale and distribution within the EU.

The Cue COVID-19 Test for Home and Over The Counter (OTC) Use
The Cue COVID-19 Test for Home and Over The Counter (OTC) Use was granted an EUA from the FDA for symptomatic and asymptomatic individuals, ages 2 and older. Tests may be purchased and self-administered (or administered on minors with adult assistance) by individual consumers without a prescription.

No, neither Cue COVID-19 test is authorized for pool testing at this time.

Pooling is the process of combining multiple swabs in one viral transport media (VTM) sample. It can save time and resources. If the pool result is Positive, individuals included in the pool need to return for repeat testing.

In 2021, Cue’s COVID-19 test became the first molecular self-test to receive Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for at-home use without a prescription. The test had previously been authorized under EUA for use by healthcare professionals and laboratories.

Now, it’s fully cleared by the FDA through the De Novo classification process after undergoing additional strict regulatory reviews to ensure that it meets the agency's stringent regulatory standards for safety and efficacy outside of the emergency use authorization state. In addition, the test will become the standard for new products of its kind.

As we break through the limitations of traditional diagnostics, we’re eager to keep pushing the boundaries of at-home testing even further, empowering people to take control of their health and unlock better outcomes with accurate diagnostics they can rely on.

The De Novo process is used to classify a novel medical device of low to moderate risk when no substantially equivalent products of its type have been cleared by the FDA.

To understand De Novo classification, it's helpful to consider another traditional pathway to FDA clearance: the 510(k) process. Clearance through 510(k) can also be requested for medical devices that are low risk or moderate risk deemed substantially equivalent to another legally marketed device. This allows for a streamlined review of a new device, as the product is compared to standards based on an existing device.

However, there are instances when a new device does not have an existing suitable predicate. De Novo classification is used in these cases, when the safety and effectiveness of a new medical device cannot be compared to a legally marketed device to determine if the new device is substantially equivalent.

When FDA grants De Novo authorization for a new medical device, it establishes a new standard for similar devices of its kind, and the new device becomes the predicate for future 510(k) submissions, creating a reference point for manufacturers subsequently seeking clearance of similar products.

The De Novo process is used to classify eligible novel medical devices when there are no substantially equivalent products that can be used to evaluate a new product. Cue's request for De Novo classification included detailed administrative information, regulatory history, device descriptions, classification summary information, and performance data to demonstrate the safety and effectiveness of our product. The FDA carefully reviewed our submission and classified our device, creating a generic product name that can be used for future product classifications.

The components and technology of our COVID-19 test remain unchanged.

The key distinctions of Cue’s COVID-19 test classified and cleared through the De Novo process and our COVID-19 test issued Emergency Use Authorizations (EUA) for home and over-the-counter use and for CLIA-Certified healthcare providers and laboratories are as follows:

• Age of user

  De Novo: 18 years and older
  EUAs: children and adults

• Symptom status

  De Novo: symptomatic
  EUAs: symptomatic or asymptomatic

• Shelf life

  De Novo: 8 months
  EUAs: 9 months

• Storage temperature

  De Novo: 59°F (15°C) to 72°F (22°C)
  EUAs: 59°F (15°C) to 86°F (30°C)

Cue’s COVID-19 test remains available under EUAs as the Cue COVID-19 Test for Home and Over The Counter (OTC) Use and as the Cue COVID-19 Test for CLIA Certified Healthcare Providers and Laboratories.

Yes. Our COVID-19 tests with De Novo authorization will be available in summer 2023. You may still purchase COVID-19 tests authorized under the EUA.

In a clinical study with lay users, the Cue OTC test demonstrated sensitivity of 97% (% positive agreement), specificity of 99% (% negative agreement), and the Lower Limit of Detection is 20 viral genome copies. Performance characteristics of diagnostic assays are generally expressed as relative numbers compared to another method. To best understand the performance characteristics, it is recommended to review the Test Performance Section of the Cue COVID-19 Test Instructions for Use (IFU) for home/OTC.

Clinical evaluation of the Cue COVID-19 OTC Test demonstrated 100% accuracy in asymptomatic individuals. For more information, you may review the Test Performance Section of the Cue COVID-19 Test Instructions for Use (IFU) for home/OTC.

The Cue COVID-19 OTC Test is the first molecular diagnostic test available over the counter in the United States. This means that Cue can be purchased and administered without a prescription. The Cue COVID-19 OTC Test delivers results comparable to that of gold-standard laboratory PCR testing methods.

Cue was granted an EUA from the FDA for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use for symptomatic and asymptomatic individuals, ages 2 and older. Tests may be purchased and self-administered (or administered with adult assistance) by individual consumers without a prescription.

Cue will be announcing distribution for the Cue COVID-19 OTC Test closer to the public launch of the product. For announcements and updates on product availability, subscribe to our newsletter.

Across 4 clinical studies, the Cue COVID-19 test demonstrated sensitivity of 99% (% positive agreement) and specificity of 98% (% negative agreement). The Lower Limit of Detection is 20 viral genome copies. Performance characteristics of diagnostic assays are generally expressed as relative numbers compared to another method. To best understand the performance characteristics, it is recommended to review the Test Performance Section of the Cue COVID-19 Test Instructions For Use (IFU) for professionals.

An independent clinical study by the Mayo Clinic published in Diagnostic Microbiology and Infectious Disease found that the overall concordance between the Cue COVID-19 test and reference laboratory nucleic acid amplification tests (NAAT) was 97.8%.

Clinical evaluation of Cue's COVID-19 test with lay users demonstrated 100% accuracy in asymptomatic individuals. For more information, you may review the Test Performance Section of the Cue COVID-19 Test Instructions for Use (IFU).

The Cue COVID-19 test External Control Swabs may remain at room temperature. For more details, please reference the Cue COVID-19 Test Instructions For Use (IFU) for professionals.

The current shelf life for the Cue Cartridges is four months, and the shelf life for the control swabs is six months at room temperature (59-86ºF). Cue is conducting ongoing stability studies and expects to be able to support longer shelf life stability claims soon.

The positive control swab is prepared with synthetic (non-infectious) RNA at approximately 150 copies per swab.

The Cue COVID-19 Test may only be provided/shipped to an entity that meets the definition of a CLIA certified laboratory or at point-of-care settings (i.e., patient care settings) operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation (referred to collectively as Authorized Laboratory). If Cue contracts with a customer that is NOT an Authorized Laboratory, then that customer must have a partnership with an Authorized Laboratory that will perform the COVID-19 testing services, and the customer must clearly identify and name the Authorized Laboratory either in the contract (preferably) or in written notice to Cue. The Cue COVID-19 Test may only be shipped to addresses designated by the Authorized Laboratory. The addresses may be included in the contract or provided to Cue by written notice.

For example, the Star Company wants to contract with Cue to purchase the Cue COVID-19 Test. The Star Company is NOT an Authorized Laboratory as defined above. The Star Company partners with XYZ Laboratories that has a CLIA Certificate of Compliance and also has CLIA Certificates of Waiver for their extension locations that do diagnostic testing at point-of-care. XYZ Laboratories is named in the Cue customer contract with Star Company as the Authorized Provider for Cue COVID-19 testing. XYZ Laboratories wants the Cue product shipped to XYZ Laboratories, c/o: Star Company at Star company’s address. This would be allowed as long as the Cue customer contract with Star Company names XYZ as the Authorized Provider XYZ designates the ship to address.

- Authorized Laboratories using the Cue COVID-19 Test must include with test result reports all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media.

- Authorized Laboratories must use the Cue COVID-19 Test as outlined in the authorized labeling. Deviations from the authorized procedures, including the authorized instruments, authorized extraction methods, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents, and authorized materials required to use the Cue COVID-19 Test are not permitted.

- Authorized Laboratories that receive the Cue COVID-19 Test must notify the relevant public health authorities of their intent to run the product prior to initiating testing.

- Authorized Laboratories using the Cue COVID-19 Test must have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate.

- Authorized Laboratories must collect information on the performance of the Cue COVID-19 Test and report to DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUAReporting@fda.hhs.gov) and Cue Health Inc. Technical Support (support@cuehealth.com) any suspected occurrence of false positive or false negative results and significant deviations from the established performance characteristics of the Cue COVID-19 Test of which they become aware.

- All operators using the Cue COVID-19 Test must be able to perform and interpret the test results, use appropriate personal protective equipment, and use the product in accordance with the authorized labeling.

- Authorized Laboratories using the Cue COVID-19 Test must ensure that any records associated with this EUA are maintained until otherwise notified by the FDA. Such records will be made available to the FDA for inspection upon request.

At current production scale, expect a new lot for every shipment from Cue, and possibly mixed lots in the shipment. Cue recommends that a positive and negative control be run with each new lot. For more details, refer to the Cue COVID-19 Test Instructions for Use (IFU) for professionals.

A Cue Wand nasal swab for collecting a patient sample is included with each Cartridge. The Cue COVID-19 Test External Control Swabs are sold separately. The Cue COVID-19 Test External Control Swabs Pack DOES NOT include test cartridges.

The Cue COVID-19 Test is administered by laboratories or point-of-care settings with the appropriate CLIA certifications. Laboratories are subject to the Federal Health Insurance Portability and Accountability Act (HIPAA). When the laboratory administers the test and the Cue Reader analyzes the Cue COVID-19 Cartridge, the result is transmitted to Cue’s secure cloud-based database and is provided to the test operator on their business device. Cue safeguards this test data in accordance with the HIPAA security standards when it is being transmitted and maintained in its database. The security of the device and the operator's account credentials are the responsibility of the operator.

Cue does not use or disclose Personal Health Information (PHI) for purposes other than providing the services and as otherwise permitted under HIPAA. Cue will sign a Business Associate Agreement with laboratories upon request.

If the test is administered by an organization with a CLIA Certificate of Waiver (for example) that is not a covered entity and therefore is not subject to HIPAA, Cue applies the exact same safeguards and standards to that organization’s personal information.

All manufacturing of Cue’s Cartridges takes place in our ISO 13485 certified facilities in San Diego, using fully automated, highly scalable production lines adhering to Good Manufacturing Practice (GMP) guidelines.

Cue’s COVID-19 tests are currently being used in healthcare, educational, and enterprise settings throughout the United States.

The Cue^® Mpox (Monkeypox) Molecular Test detects nucleic acid of monkeypox, the virus that causes mpox (previously known as monkeypox). Using isothermal nucleic acid amplification technology (NAAT), the test determines if monkeypox is present in samples collected directly from skin lesions or in samples collected from skin lesions in viral transport media from people suspected of having mpox by a healthcare provider.

The Cue Mpox (Monkeypox) Molecular Test uses nucleic acid amplification technology (NAAT) to generate a molecular amplification reaction, which is an equivalent alternative amplification method to real time polymerase chain reaction (RT-PCR).

The Cue Mpox (Monkeypox) Molecular Test contains primers, probes, and internal controls used in molecular tests to detect monkeypox virus nucleic acid. The test was issued Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) for use by authorized laboratories or by healthcare professionals at the point-of-care. When the user inserts the Cue Sample Wand with a skin lesion sample into the Cue Test Cartridge, the test automatically begins. Heating, mixing, amplification, and detection take place within the single-use test cartridge, and results are transmitted to the user to a compatible mobile device in around 25 minutes.

For a more detailed description of how this test works, please visit Product Documentation and refer to the Instructions For Use (IFU).

Based on results of a clinical study sponsored by Cue and submitted to FDA for Emergency Use Authorization, the Cue Mpox (Monkeypox) Molecular Test is 100% accurate. Test performance was evaluated with 59 de-identified archived clinical lesion swab samples in viral transport media (VTM) (30 positive samples and 29 negative samples) collected by trained personnel from patients suspected of having mpox. Untrained personnel tested the samples. The positive percent agreement (PPA) and negative percent agreement (NPA) of the Cue Mpox (Monkeypox) Molecular Test compared to an FDA-cleared real-time PCR assay were both 100%.

The Cue Mpox (Monkeypox) Molecular Test is easy to understand and requires minimal training. Our cartridges are self-contained and come ready for immediate use with the Cue Health Monitoring System (Cue Reader). No sample preparation or reagent mixing is needed, and the Cue Health App guides users with step-by-step videos and prompts. Samples must be collected by healthcare professionals trained to collect skin lesion samples. Refer to your institution's training and certification guidelines before using Cue.

The Cue Mpox (Monkeypox) Molecular Test is authorized for use in point-of-care settings by laboratories or other organizations certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a that meet requirements to perform high, moderate, or waived complexity tests. Testing is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

For directions, precautions, and additional information, please see the Cue Mpox (Monkeypox) Molecular Test Instructions For Use (IFU).

Reimbursement varies by payor, and we are actively working with health insurance companies to ensure coverage for Cue’s tests. We encourage you to check with specific payors for pathways of reimbursement and coverage for the Cue Mpox (Monkeypox) Molecular Test.

Some providers use CPT code 87593 for reimbursement: Infectious agent detection by nucleic acid (DNA or RNA); orthopoxvirus (eg, monkeypox virus, cowpox virus, vaccinia virus), amplified probe technique, each.

The coding information contained here is for informational purposes only and is not a guarantee of coverage or reimbursement for any product or service. We recommend you consult with your CPT code advisors for guidance. To view existing CPT codes, please visit CodeMap.

The U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the Cue Mpox (Monkeypox) Molecular Test. This test may be used for the qualitative detection of DNA from the monkeypox virus (clade I/II) in human lesion swab specimens (i.e., swabs of acute pustular or vesicular rash) from individuals suspected of having mpox by their healthcare provider.

Conditions of Authorization for clinical laboratories and patient care settings are listed below. The FDA Letter of Authorization, Instructions for Use, authorized fact sheets for healthcare providers and patients, and authorized labeling are available at cuehealth.com/docs.

• Authorized laboratories* that receive the Cue Mpox (Monkeypox) Molecular Test must notify the relevant public health authorities of their intent to run the product prior to initiating testing. Authorized laboratories are responsible for understanding and satisfying their own reporting and use obligations.
• Authorized laboratories using this test must have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate.
• Authorized laboratories using this test must include with test result reports all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media.
• Authorized laboratories using this test must use it as outlined in the authorized labeling. Deviations from the authorized procedures, including the authorized instruments, authorized extraction methods, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to use this test are not permitted.
• Authorized laboratories must have a process in place to track adverse events and report to Cue Customer Technical Support (833-283-8378) and to FDA pursuant to 21 CFR Part 803.
• All operators using this test must:
  • be appropriately trained in performing and interpreting the results of this test
  • use appropriate personal protective equipment to collect skin lesion samples and when handling this test
  • use this test in accordance with the authorized labeling
• Cue Health Inc., authorized distributors, and authorized laboratories must collect information on the performance of this test and report any significant deviations from established performance characteristics to DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUA Reporting@fda.hhs.gov). In addition, authorized distributor(s) and authorized laboratories must report to Cue Health Inc. (833.283.8378 or support@cuehealth.com).
• Cue Health Inc., authorized distributors, and authorized laboratories using this test must ensure that any records associated with this EUA are maintained until otherwise notified by FDA. Such records will be made available to FDA for inspection upon request.

*The letter of authorization refers to “authorized laboratories” as follows: Testing on the Cue Health Monitoring System (Cue Reader) and Cue Cartridge is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived complexity tests. Testing is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

The Cue Mpox (Monkeypox) Molecular Test Cartridge Pack comes with foil pouches, which each contain a plastic tray with one (1) single-use Cue Mpox (Monkeypox) Molecular Test Cartridge and one (1) single-use wrapped sterile Cue Sample Wand. The storage temperature range of this test is between 59°F (15°C) to 86°F (30°C). Do not use Cartridges that have been stored outside of this temperature range. Use caution when using this test outdoors, as it has not been tested at extreme high or low temperatures or in highly humid environments.

Yes. Please refer to the ‘Use By’ date on the test’s packaging.

The confirmed LoD of this test is 1 genome copy/Sample Wand for direct swabbing and 1.5 genome copies/Sample Wand for specimens in viral transport media (VTM). The LoD of both sample collection methods were found to be equivalent.

This test may only be provided to an entity that meets the definition of a CLIA certified laboratory or at point-of-care settings (i.e., patient care settings) operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation (referred to collectively as Authorized Laboratory). If Cue contracts with a customer that is NOT an Authorized Laboratory, then that customer must have a partnership with an Authorized Laboratory that will perform the testing services, and the customer must clearly identify and name the Authorized Laboratory in the contract. This test may only be shipped to addresses designated by the Authorized Laboratory. The addresses may be included in the contract or provided to Cue by written notice.

External controls are validated for this test, and are available through ZeptoMetrix, a third-party vendor. Refer to catalog numbers NATMPXV-ERC (Positive Control) and NATSARS(COV2)-NEG (Negative Control). To purchase, visit www.zeptometrix.com or call (800) 274-5487.

The test is administered by laboratories or in point-of-care settings with the appropriate CLIA certifications, which may be subject to the federal Health Insurance Portability and Accountability Act (HIPAA) and other privacy standards. Results are transmitted to Cue’s secure cloud-based database and provided to the test operator on their compatible mobile device. Cue safeguards this test data in accordance with HIPAA security standards.

Cue does not use or disclose Personal Health Information (PHI) for purposes other than providing the services and as otherwise permitted under HIPAA. Cue will sign a Business Associate Agreement with laboratories upon request.

If the test is administered by an organization with a CLIA Certificate of Waiver (for example) that is not a covered entity and therefore is not subject to HIPAA, Cue applies the same safeguards and standards to that organization’s protected information.

Yes. Before an operator or administrator of a test uses the Cue Health App, they must register for an account and agree to the Cue Health App Terms of Use (End User License Agreement) and Privacy Policy. Upon user consent, a verification email is triggered to complete the account creation process.

Once a test result is transferred from the Cue Reader to the Cue Health App on a compatible device, the test result is deleted from the Reader memory. Therefore, the Reader does not retain any Personal Health Information (PHI) or Personally Identifiable Information (PII).

The Customer Data (including test results and identifiers) are stored in MongoDB which is a SAAS solution that provides cloud-based HIPAA compliant storage. Cue has executed a HIPAA Business Associate Agreement with MongoDB to protect Customer Data.

Yes, Cue is willing to sign a Business Associate Agreement (BAA) with Authorized Laboratories that are covered entities under the Health Insurance Portability and Accountability Act (HIPAA). Whether or not Cue signs a BAA, it protects all its data in accordance with the HIPAA privacy, security, and data breach notification rules.

Cue takes information security very seriously and has taken measures to ensure the confidentiality and integrity of sensitive data. Cue is ISO 27001 certified and the certification number is: 25912-001

International Organization for Standardization (ISO) is an independent, non-governmental international organization that strives to develop voluntary, consensus-based, market-relevant international standards that support innovation and provide solutions to global challenges.

ISO 27001 is an international standard that helps organizations manage the security of their information assets. It provides a management framework for implementing an ISMS (Information Security Management System) to ensure the confidentiality, integrity, and availability of sensitive data (such as customer data, financial information, intellectual property, employee details or information managed by third parties).

Learn more about ISO and ISO 27001 certification.