Detect™ Covid-19 Test Receives FDA Emergency Use Authorization for Over-the-Counter Home Use

Rhea-AI Summary

Detect, Inc. announces that its PCR-quality at-home Covid-19 Test has received Emergency Use Authorization from the U.S. FDA. The test provides results in one hour, making it ideal for home, school, and workplace use. With an overall agreement of 97.3%, a sensitivity of 90.9%, and 100% specificity, it is among the most accurate home tests available. Priced under $50, it stands as the lowest-cost molecular test on the market. The test is designed to detect all current variants of concern and is supported by an $8.1 million NIH contract to scale up manufacturing.

Positive

• Received Emergency Use Authorization from the U.S. FDA for at-home use.
• Test demonstrates 97.3% overall agreement, with 90.9% sensitivity and 100% specificity.
• Lowest priced at-home molecular test on the market at under $50.
• Supported by an $8.1 million contract from the National Institutes of Health.

Negative

• None.

PCR-Quality Rapid Test Provides Results in One Hour—Ideally Suited for Home, Schools, Workplaces, and Travel

GUILFORD, Conn.--(BUSINESS WIRE)-- Detect™, Inc., a Connecticut-based health technology company, announced today that its PCR-quality, at-home rapid molecular Detect™ Covid-19 Test received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for Over-the-Counter Home Use.

The Detect™ Covid-19 Test provides PCR-quality results in one hour all from the comfort of your home. 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 is a unique molecular rapid test that combines the sensitivity of a PCR lab test with the convenience, simplicity, and scalability of a typical rapid test. Detect’s innovative technology identifies SARS-CoV-2, the virus responsible for Covid-19, at lower viral loads than antigen tests, allowing for earlier detection to mitigate pre-symptomatic spread. But unlike traditional laboratory testing, the Detect Covid-19 Test can be done entirely at home in one hour.

When compared to a highly sensitive PCR test in clinical studies, the Detect Covid-19 Test demonstrated 97.3% overall agreement, with 90.9% sensitivity and 100% specificity¹ when the test results were interpreted correctly, which makes it among the most accurate tests available for home use.

Detect has taken a consumer-centric approach to the entire testing experience—from purchasing the test through communicating results. The Detect Covid-19 Test will be available for purchase at detect.com in the coming weeks, with retail pricing under $50, making it the lowest priced at-home molecular test on the market and significantly less costly than PCR laboratory tests. The test will also be used in schools and workplaces for regular screening programs, using a serial testing approach for anyone who does not have either symptoms or exposure, and for reliable and convenient PCR-quality testing when individuals are symptomatic or exposed.

The Detect Covid-19 Test uses mobile app-based instructions to guide the user through the test-taking process. The Detect™ App helps users perform the test and interpret their results correctly. To ensure that results can be used for travel and event entry, Detect is also developing an electronic travel pass system with an add-on telehealth service. This will enable users to take the test under the virtual guidance of a healthcare professional, providing a verified result.

“The Detect Covid-19 Test brings laboratory accuracy into the home, helping to mitigate Covid-19 transmission and make everyday activities safe and anxiety-free again,” remarks Dr. Jonathan Rothberg, founder of Detect, Inc. “As a complement to vaccines, highly accurate rapid testing will be critical as the pandemic becomes endemic. We developed the Detect Covid-19 Test to help people return to doing the things they love with the people they love in the safest way possible.” Rothberg received the National Medal of Technology and Innovation for inventing next-generation DNA sequencing, and leads 4Catalyzer, the biotechnology incubator that launched several other successful health technology companies, including Butterfly Network (NYSE: BFLY), Quantum-Si (Nasdaq: QSI) and Hyperfine.

With a limit of detection of 313 copies per swab (less than 1 copy per microliter), the test finds and amplifies small segments of viral RNA, which enables it to identify an infection earlier than an antigen test. The test is designed to detect all currently circulating Variants of Concern and Variants of Interest, including Delta. Detect uses state-of-the-art software to monitor all circulating strains of SARS-CoV-2 to ensure that the test continues to maintain high accuracy as new Variants of Concern and Variants of Interest appear.

“Detect’s proprietary technology puts the complex nucleic acid amplification process into an easy-to-use and affordable format, bringing the gold standard of Covid-19 testing into the home,” says Eric Kauderer-Abrams, Chief Technology Officer of Detect, Inc. “Detect is helping to create a future in which home testing can bring peace of mind to everyone, without compromising quality and accuracy.”

As a testament to the Detect Covid-19 Test’s performance and ability to meet national testing needs, the Detect Covid-19 Test was recently selected by the highly competitive National Institutes of Health (NIH) Rapid Acceleration of Diagnostics Initiative (RADx^SM) for an $8.1 million contract to scale up manufacturing.

About Detect™, Inc.:

Detect, Inc. (www.detect.com) 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.

The Detect Covid-19 Test has not been FDA cleared or approved but has been authorized by FDA under 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.

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.

¹ When interpreted by lay individuals the specificity was 97.5% and the overall agreement was 95.5% because two users reported the incorrect result in an older version of the Detect™ App.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211029005300/en/

Shawna Marino

press@detect.com

Source: Detect, Inc.

FAQ

What is the Detect Covid-19 Test and how does it work?

The Detect Covid-19 Test is an at-home PCR-quality test that provides results in one hour, combining lab accuracy with home testing convenience.

When was the Detect Covid-19 Test authorized for home use?

The Detect Covid-19 Test received Emergency Use Authorization from the U.S. FDA.

What are the accuracy metrics for the Detect Covid-19 Test?

The test shows 97.3% overall agreement, with 90.9% sensitivity and 100% specificity when interpreted correctly.

How much does the Detect Covid-19 Test cost?

The test is priced under $50, making it the lowest-cost at-home molecular test available.

What support has Detect, Inc. received for manufacturing the test?

Detect has secured an $8.1 million contract from the National Institutes of Health to scale up manufacturing.