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Lucira Health’s Unexpected Sprint To A First-Of-Its-Kind EUA From FDA: The Inside Story

The company wasn’t aiming to be the first to get an emergency use authorization for an at-home molecular COVID-19 test – but it was

 
• By Shawn M. Schmitt

Lucira Health executive VP Kelly Brezoczky explains in this Medtech Insight case study how the company shifted gears from making a test for influenza A and B to quickly developing one that detected SARS-CoV-2. The result was the company’s COVID-19 All-In-One Test Kit, an at-home prescription molecular diagnostic test that was the first of its type to hit the market when the US FDA granted it emergency use authorization last November.

Athlete about to start sprinting

It was early 2020, and Lucira Health was busy working on an at-home test for detecting influenza A and B when the first reports of a novel coronavirus began trickling through the media.

“We were on the path to [US Food and Drug Administration] authorization in flu when the pandemic hit. And it didn’t take long for everybody to realize that the pandemic...

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