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Detect Gets FDA Emergency Use Authorization for OTC, At-Home Molecular SARS-CoV-2 Test

NEW YORK — The US Food and Drug Administration on Thursday said it has granted Emergency Use Authorization for Detect's over-the-counter, at-home SARS-CoV-2 test.

The Detect Covid-19 Test uses reverse transcriptase loop mediated isothermal amplification, or RT-LAMP, and lateral flow strip technologies to detect the SARS-CoV-2 ORF1ab gene in self- or adult-collected anterior nasal swab samples. It comprises a collection swab, testing tube, and a reusable sample processing device.

According to Guilford, Connecticut-based Detect, the test will be available for purchase online in the next few weeks for under $50.

The FDA noted in a statement that the test requires the use of a smartphone and an app to deliver results in about an hour. 

Detect, formerly known as Homodeus, was originally focused on developing a platform to modify molecules found in nature to improve things like gene editing, but it shifted its attention to SARS-CoV-2 testing when the pandemic began.

Earlier this month, the company received an $8.1 million contract through the National Institutes of Health's Rapid Acceleration of Diagnostics initiative to develop and scale up manufacturing of its COVID-19 test.