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November 1, 2021

Guilford’s Detect heads to market with over-the-counter COVID test following FDA green light

PHOTO | CONTRIBUTED Detect’s at-home Covid-19 test is suitable for ages 2+ and uses a nostril swab.
By Natalie Missakian

At the start of the pandemic, serial entrepreneur Jonathan Rothberg and one of his Guilford companies set out to develop a rapid home test for COVID-19 that could rival the accuracy of a standard lab test.

That over-the-counter test, called Detect, is now about to hit the market. 

Made by a startup that shares its name, the test won emergency use authorization last Thursday from the U.S. Food and Drug Administration and will be available “within weeks” for online purchase, the company announced.

The company said its test demonstrated 97.3% overall agreement with a PCR lab test in clinical trials, which, according to Detect, makes it more sensitive than more common antigen-based rapid tests. It promises results within an hour.

“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, the company’s founder, said in a statement. He cited a continued need for testing as a complement to vaccines “as the pandemic becomes endemic.” 

Although Detect joins several other home tests already on the market, experts say rapid COVID-19 tests remain in short supply in the U.S., according to recent news reports. The Biden administration in October announced plans to invest $1 billion to expand the supply of at-home tests.

Last month, Detect won $8.1 million from the National Institutes of Health to scale up manufacturing of the test.

The test finds and amplifies small segments of viral RNA, which, according to the company, allows it to detect an infection earlier than antigen tests, which identify certain proteins in the virus. Detect is counting on that sensitivity to help cut down pre-symptomatic spread of the disease. 

Detect’s test comes with a reader, nasal swab and buffer and uses a mobile app to guide users through the testing process and help them interpret results. 

It’s designed to detect all variants of the coronavirus, and Detect envisions it being used by schools and workplaces for regular screening of students and employees. 

Detect will initially be sold only on the company’s website, detect.com, but it could hit retail stores, pharmacies, and e-commerce sites such as Amazon by early 2022, a spokeswoman said in an email.  She said the test will have a starting retail price of $50 or less.

Contact Natalie Missakian at news@newhavenbiz.com

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