Meet Cue®: Accurate point-of-care testing in 20 minutes
Bring the unparalleled combination of accuracy, speed, and innovation of the Cue Integrated Care Platform to your healthcare organization and patients.Get Cue Now
Fast, accurate testing you can rely on
Cue’s molecular COVID-19 test combines fast results and ease of use with the accuracy of central lab technology to deliver diagnostics that your organization — and patients — can rely on to make timely health decisions.
When compared to lab-based PCR testing in clinical study results submitted to the FDA for EUA.
Symptomatic and asymptomatic detection
Effective early detection among infected individuals with or without symptoms.
CPT code 87635*
Cue products and COVID-19 tests may be reimbursable.
Seamless EHR integration
Intuitive dashboard syncs with your existing EHR systems for ordering, testing, tracking, and reporting.
*The coding information contained here is for informational purposes only, and is not a guarantee of coverage or reimbursement for any product or service.
Backed by science
The accuracy and efficacy of Cue’s diagnostic capabilities have been put to the test by some of the most reputable researchers in the industry.
How Cue can help
A scalable solution for healthcare organizations
Whether you’re running a large healthcare network or an intimate family practice, Cue streamlines your ability to deliver value-based care with ultra-fast, highly accurate test results on demand.
Automated Data Reporting
Streamlined and compliant data reporting you can rely on.
Easy to implement within existing infrastructure; no training required.
Fast test processing and the ability to run multiple tests simultaneously.
Highly sensitive and specific molecular testing with PCR-quality results.
Portable & Compact
Minimal footprint, easily transported for remote or offsite use.
Easily scalable within an organization or across a network.
Seamless integration with your existing EHR systems.
Fully compatible with future Cue tests.
How Cue® works
The Cue Integrated Care Platform
The streamlined Cue system is designed to provide you with the accuracy and speed you need to treat patients in real-time — all from a device that fits in the palm of your hand.
Efficient and intelligent, the reusable Cue Reader swiftly processes tests and communicates the results to the Cue Health App via Bluetooth®. Up to six Readers can be connected to the Cue Health App at one time for increased testing capacity.
Our sample-specific, single-use tests are designed with ease of use and safety in mind. All the components for the complex chemistry needed to perform each test are already contained within each cartridge. No mixing required.
A connected system
The Cue Health App and Dashboard work together to help you manage patient profiles, communicate results, analyze trends, and comply with reporting. The Dashboard seamlessly syncs with your existing EHR system.
A holistic approach to health
Designed as a complete diagnostic system, Cue’s future care offerings feature a wide range of tests including respiratory health, sexual health, women’s health, and overall wellness — all compatible with the Cue Reader.
Ready for smarter, faster diagnostics?
Connect with our team to discuss the right solution for your healthcare organization or request a demo of our technology.Get Cue Now
Ways to bring Cue to your organization
There are several ways to bring Cue’s innovative diagnostics to your healthcare organization. No matter which way you choose, you’ll always have the full support of our team behind you.
Purchasing Cue Readers and tests for a small practice? Shop our online store directly. Dashboard and other enterprise options not available with online purchase. Contact us to learn more.Shop now
Connect with us
Need to set up an account or connect with one of our trusted distributors? Fill out the form below for some one-to-one support.Contact us
Proven results at point-of-care
Interested in bringing Cue to your organization?
Connect with our team to discuss the right solution for your healthcare organization or request a demo of our technology.
The Cue COVID-19 Test for CLIA Certified Healthcare Providers and Laboratories (Cue COVID-19 Test) is streamlined, easy-to-use, and doesn’t require any specific training to operate.
The Cue COVID-19 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 and meets the requirements to perform high, moderate, or waived complexity tests. The test is also authorized for use in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
For directions, conditions of authorization, precautions, and additional information, please see the Cue COVID-19 Test Instructions For Use (IFU).
As of January 15, 2022, private insurance companies in the United States are required to reimburse their members for COVID-19 tests, per a federal requirement.
Methods and amounts of reimbursement vary by payor, and we encourage you to check with specific payors about their policies regarding reimbursement.
Some providers use 87635 as the CPT code for reimbursement: Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]).
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 our CPT code advisors for guidance.
Cue COVID-19 Test for CLIA Certified Healthcare Providers and Laboratories
The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the Cue COVID-19 Test for Professional use. The Cue COVID-19 Test may be used to test symptomatic and asymptomatic individuals for the detection of nucleic acid from SARS-CoV-2. 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 for Home and Over The Counter (OTC) Use
The FDA granted the Cue COVID-19 Test Emergency Use Authorization (EUA) for Home and Over The Counter (OTC) Use for the detection of nucleic acid from SARS-CoV-2 in symptomatic and asymptomatic individuals, ages 2 and older. Tests may be purchased without a prescription and self-administered by adults or administered on minors with adult assistance.
- Authorized Laboratories using the Cue COVID-19 Test must include all authorized fact sheets along with test result reports. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media.
- Authorized Laboratories must follow Cue’s COVID-19 Test Instructions For Use. Deviations from the authorized procedures, including authorized clinical specimen types and authorized control 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 (firstname.lastname@example.org) 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.
The reimbursement CPT code for Cue’s COVID-19 Test is: 87635 — Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19])
The coding information contained here is for informational purposes only, and is not a guarantee of coverage or reimbursement for any product or service.
Fact Sheet for Healthcare ProfessionalsDownload
Instructions For Use (IFU)Download
Quick Reference InstructionsDownload
FDA EUA LetterDownload
Cue’s COVID-19 Test has not been FDA cleared or approved; but has been authorized by FDA under an EUA. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.