Detect gets FDA EUA for over-the-counter home use COVID test

Detect, Inc., a Connecticut-based health technology company, announced today that its PCR-quality, at-home rapid molecular Detect™ Covid-19

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 (RADxSM) for an $8.1 million contract to scale up manufacturing. Business Wire