Detect™ Selected by NIH to Scale Manufacturing of PCR-Quality Rapid At-Home Covid-19 Test
RADxSM Initiative to Invest $8.1 Million in Detect™ Covid-19 Test, Currently Pending FDA Emergency Use Authorization
GUILFORD, Conn.--(BUSINESS WIRE)--#Covid19--Detect™, Inc., a Connecticut-based health technology company, announced today that the National Institutes of Health (NIH) has selected the Detect™ Covid-19 Test to receive funding from the highly competitive Rapid Acceleration of Diagnostics Initiative (RADxSM). The $8.1 million contract will facilitate the development and scale up manufacturing of Detect’s PCR-quality rapid at-home Covid-19 test to meet national testing demand.
The Detect Covid-19 Test, currently undergoing U.S. Food and Drug Administration (FDA) review, provides lab-accurate results, at home, in approximately one hour. With mobile app-based instructions to guide the user, it combines the accuracy of a molecular nucleic acid amplification test (NAAT) with the simplicity and scalability of a rapid test. The Detect Covid-19 Test is specifically designed for large-scale, low-cost manufacturing, which sets it apart from other molecular tests on the market today. In addition to simple and reliable home use, the test is ideal for schools, businesses, and nursing homes.
“President Biden’s Covid-19 Action Plan states that highly accurate and accessible Covid-19 testing with rapid results is critical to stopping transmission and allowing people to live their lives safely again,” says Dr. Jonathan Rothberg, founder of Detect, Inc. as well as several other successful health technology companies, including Butterfly Network (NYSE: BFLY), Quantum-Si (Nasdaq: QSI) and Hyperfine. “Our team of scientists have developed technology that brings the highest quality of laboratory testing into your home. We are extremely grateful to have the support of the NIH RADxSM initiative to make the Detect Covid-19 Test scalable and affordable.”
The NIH, the nation's preeminent medical research agency, established the RADxSM initiative in April 2020 to speed innovation in the development, commercialization and implementation of technologies for Covid-19 testing. The National Institute of Biomedical Imaging and Bioengineering (NIBIB) leads one arm of this initiative, RADx Tech, which facilitates the validation, scale-up, and deployment of novel diagnostic tests. To date, the program has played an integral role in scaling the nation’s testing capacity, including investing in the critically important at-home testing market.
“In addition to direct funding, the RADxSM initiative provides invaluable public and private sector expertise across technology, regulatory, commercialization, marketing, and clinical focus areas,” says Eric Kauderer-Abrams, Chief Technology Officer of Detect, Inc. “This partnership will allow us to deliver highly accurate Covid-19 testing to the U.S. market sooner -- fulfilling the nation’s unprecedented demand for convenient and reliable at-home testing.”
The Detect Covid-19 Test is intended for all known variants, including Delta. Upon FDA authorization, the test will initially be used in K-12 schools, workplace screening programs, and available for direct-to-consumer purchase via detect.com.
About Detect™, Inc.:
Detect, Inc. is a health technology company with the mission to build tools that empower people to understand their health and make informed, timely decisions by bringing accurate testing into the home. Founded by world-renowned scientist, entrepreneur and National Medal of Technology and Innovation recipient, Dr. Jonathan Rothberg, Detect Inc. has created an accurate, fast, and easy-to-use PCR-quality molecular Covid-19 test. The technology also serves as a platform for future home tests, such as influenza and STIs. Detect, Inc. is part of 4Catalyzer, a health technology accelerator that strives to transform 21st century medicine by solving today’s most challenging problems – across life science research tools, medical devices and therapeutics. To learn more, visit: detect.com and 4catalyzer.com
This project is supported by the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative and has been funded in whole or in part with federal funds from NIBIB, NIH, Department of Health and Human Services, under Contract No. 75N92022C00002.