Cue Health Closes $100 Million Series C Financing to Support Launch of Rapid Molecular Testing Platform
San Diego, CA (June 10, 2020) - Cue Health Inc. (“Cue”), a healthcare technology company, announced today the close of its Series C financing round, raising $100 million in new capital.
Investors in Cue’s Series C include Menlo Park-based Decheng Capital, Foresite Capital, Madrone Capital Partners, Johnson & Johnson Innovation - JJDC, Inc., ACME Capital and other investment firms.
Proceeds from the financing will be used to complete development, validation, and scale-up of manufacturing of the Cue Health Monitoring System and Cue Test Cartridges. Cue’s operations, including manufacturing, are vertically integrated and currently occupy approximately 55,000sqft in San Diego, CA USA. The company plans to increase its footprint to over 110,000sqft to better support development and commercialization of its products, including a fast, portable, and easy-to-use molecular test for COVID-19, which is currently under review by the FDA for an Emergency Use Authorization.
Ayub Khattak, co-founder and CEO of Cue, said, “The COVID-19 pandemic has highlighted the need for a rapid, easy-to-use platform for diagnostics in decentralized settings to respond to existing and emerging threats. Healthcare settings such as nursing homes, emergency departments, and community health clinics need tools to allow them to access molecular test information immediately rather than waiting hours or days for lab results. Cue is grateful that our team’s years of hard work and preparation have put us in a position to assist with the current emergency and future threats.”
“We are excited to welcome strong healthcare and life-science focused investors that align with our vision for how diagnostics should evolve. Ultimately, broad distribution of the connected Cue platform to both healthcare professionals and consumers will enable a new model of rapid, on-demand diagnostic testing and enhanced telemedicine capabilities, changing the way important health information is accessed and acted on.
Apart from its COVID-19 solution, Cue is also completing the validation needed for FDA submission of its portable system for at-home influenza A and B testing. That approval would mark the first at-home molecular flu test that is rapid (~20 minutes) and enables connectivity via telemedicine networks to a healthcare provider of the patient’s choice. Cue also anticipates the introduction of a series of infectious disease tests and products for other test categories in the coming years.
In addition to private financing, the company has been awarded contracts totaling more than $30 million by the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (“BARDA”), which coordinates some of the HHS response to disasters and public health emergencies. BARDA funding has helped enable Cue to accelerate the development of its influenza and COVID-19 tests.
Goldman Sachs & Co. LLC acted as exclusive placement agent for the Series C financing. WilmerHale and Foley & Lardner LLP acted as legal advisors to the company with respect to the financing.
About the Cue Health Monitoring System
The Cue Health Monitoring System is a portable, compact, connected diagnostic platform that provides the power of lab-quality molecular testing at point-of-care, when and where it is needed the most. The Cue Health Monitoring system works with the Cue Test Cartridge, the Cue Sample Wand, and the Cue Health App to convert test samples into accurate digital results. The single-use Cue Test Cartridge contains all the biochemistry needed to perform the molecular test. The Cue Sample Wand is a nasal swab supplied with the Cue Test Cartridge. The reusable, battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results directly to the Cue Health App in about 20 minutes via a mobile smart device. The Cue Health App on the user’s mobile smart device is the user interface for test information, instructions, and display of the test results. Designed as a complete diagnostic tool, the Cue Health Monitoring System along with the Cue Test Cartridge and the Cue Health App deliver actionable health data at point-of-care.
COVID-19 Test Cartridge
The Cue COVID-19 Test Cartridge is a single-use, self-contained unit that utilizes proprietary technology to apply the reagents and associated materials required for molecular detection of the SARS-CoV-2 virus, the virus that causes COVID-19. The Cue COVID-19 Test is a high-sensitivity molecular assay that is being deployed to address urgent unmet needs in COVID-19 testing. On June 10, 2020, Cue received Emergency Use Authorization (EUA) from the US Food and Drug Administration for use of the Cue COVID-19 Test Cartridge with the Cue Health Monitoring System to detect nucleic acid from SARS-CoV-2 in nasal specimens from individuals who are suspected of COVID-19 by their healthcare provider.
About Cue Health
Cue Health Inc. (“Cue”) is an ISO 13485-certified company founded by Ayub Khattak and Clint Sever focused on developing and manufacturing professional and consumer medical diagnostic products that can be used in clinical or at-home settings. Cue’s mission is to create tools that empower healthcare providers and consumers by increasing their access to actionable health data. Cue’s first product, the Cue Health Monitoring System with the Cue COVID-19 Test Cartridge, is a platform that provides diagnostic information to clinicians and patients seeking to benefit from a connected healthcare delivery ecosystem. The company is based in San Diego, CA. For more information visit www.cuehealth.com
These products have not been FDA cleared or approved; but have been authorized by FDA under an EUA. These products have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of these products 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.
June 10, 2020
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