COVID-19 testing newcomer Detect aims to reset expectations for regular screening against the pandemic coronavirus—and it’s now received an FDA green light to move forward with its rapid, lab-quality test for repeated use in the home.
The company’s molecular diagnostic received an emergency authorization allowing it to be sold at retail stores over-the-counter. Equipped with a reusable analyzer and $50 cartridge-based tests, the system aims to produce results with PCR-level accuracy within one hour.
Founded by serial medtech entrepreneur Jonathan Rothberg—who previously helped launch hand-held ultrasound developer Butterfly Network and portable MRI maker Hyperfine—Detect also hopes to provide routine testing in schools and workplaces, screening people regardless of whether they’re showing symptoms.
The test, which showed zero false positives and a false-negative rate of about 9% in clinical studies, is designed to identify the virus at lower concentrations compared to the antigen-based tests that are typically used for rapid results.
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“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,” Rothberg said in a statement. “As a complement to vaccines, highly accurate rapid testing will be critical as the pandemic becomes endemic.”
The RNA amplification test relies on a mobile app to guide the user through the process and assists them in interpreting the results. In the future, Detect plans to develop an electronic pass system that will allow the test taker to use their molecular test results for air travel and for entering large events.
The company also said it is working on a telehealth service to help remotely verify results and that its reusable hub could one day serve as a platform for home-based tests for the flu or sexually transmitted infections.
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“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,” said Detect’s chief technology officer, Eric Kauderer-Abrams.
The company and its test were picked by the National Institutes of Health’s rapid diagnostics competition, known as RADx, to receive a $8.1 million contract earlier this month to help scale up manufacturing efforts.
The test is designed to capture all known variants of the coronavirus, including delta, while also being cheaper to produce in large numbers compared to previous molecular tests, the company said.