Detect™ Selected by NIH to Scale Manufacturing of PCR-Quality Rapid At-Home Covid-19 Test

Rhea-AI Summary

Detect, Inc. has secured an $8.1 million funding award from the National Institutes of Health (NIH) under the RADx initiative to advance its Detect™ Covid-19 Test. This test is currently pending FDA Emergency Use Authorization and promises PCR-quality results at home in approximately one hour. The funding will aid in scaling manufacturing to meet national demand. Designed for schools, businesses, and homes, the Detect Covid-19 Test targets all known Covid-19 variants, including Delta, enhancing accessible testing options in the U.S.

Positive

• Secured $8.1 million funding from NIH for the development and manufacturing of Covid-19 test.
• Test provides PCR-quality results at home in about one hour, enhancing convenience.
• Designed for scalability, addressing significant national testing demand.
• Targets all known variants, ensuring broad applicability in schools and businesses.

Negative

• None.

RADx^SM Initiative to Invest $8.1 Million in Detect™ Covid-19 Test, Currently Pending FDA Emergency Use Authorization

GUILFORD, Conn.--(BUSINESS WIRE)-- 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 (RADx^SM). 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 provides PCR-quality results for use at home in approximately one hour. The test includes a reusable Detect™ Hub (sold separately), a Detect™ Test Reader, a Dropper pre-filled with buffer, a nasal swab designed by Detect™, a Test Tube with pre-filled liquid buffer and a proprietary reagent bead that dissolves in the Test Tube liquid. The Detect™ App guides the user through each step of the test-taking process and stores results for travel or venue entry. (Photo: Business Wire)

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 RADx^SM initiative to make the Detect Covid-19 Test scalable and affordable.”

The NIH, the nation's preeminent medical research agency, established the RADx^SM 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 RADx^SM 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 (RADx^SM) 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211014006048/en/

Shawna Marino

press@detect.com

Source: Detect, Inc.

FAQ

What is the recent funding amount for Detect, Inc. related to its Covid-19 test?

Detect, Inc. received $8.1 million from the NIH for its Covid-19 test.

What is the status of the Detect™ Covid-19 Test with the FDA?

The Detect™ Covid-19 Test is currently pending FDA Emergency Use Authorization.

What variants does the Detect Covid-19 Test target?

The Detect Covid-19 Test is intended for all known variants, including Delta.

How long does it take to get results from the Detect Covid-19 Test?

The test provides results in approximately one hour.

Who is funding the Detect Covid-19 Test development?

The funding is provided by the National Institutes of Health through the RADx initiative.