Detect scores EUA from FDA for at-home molecular COVID-19 test

Health tech company Detect announced Friday it had received emergency use authorization from the Food and Drug Administration for its at-home molecular COVID-19 test. 

The Detect test uses an app to help users perform and interpret their results. The company said it’s also working on an electronic travel pass system with a telehealth service so its offering can be used for travel and events. 

“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,” Dr. Jonathan Rothberg, founder of Detect, said in a statement.

“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.”


Detect is pitching its COVID-19 test as a more accurate option that can be done in an hour at home, without the need for lab analysis.

The company said the Detect test showed 97.3{eca2258439cb6473656e03a2d3e6b84304b35fc01c093883e008a47bacba1047} overall agreement with a polymerase chain reaction (PCR) test, typically performed in a lab. 

Most at-home tests are antigen tests, which take less time to get results, but can be less accurate than a molecular test. 


Other makers of at-home COVID-19 tests include Ellume, Cue Health, Lucira and Abbott.

Rapid, at-home COVID-19 tests have been in short supply over the past couple of months in the U.S., and the test prices can vary. 

Earlier this month, the Biden administration announced it would allocate an additional $1 billion to purchase more rapid tests in response to the shortage. 

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