Bay Area company creates 1st ever at-home test to diagnose COVID, flu at same time

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Tuesday, August 16, 2022
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Lucira Health has applied for FDA approval for the first test that can diagnose not only COVID but also the influenza A and B strains with one sample.

EMERYVILLE, Calif. (KGO) -- The convenience and reliability of at-home COVID tests are ushering in a new era of testing for other diseases.

A Bay Area biotech firm is seeking approval for a self-test that will diagnose the flu in addition to COVID-19 and could help to prevent the spread of other contagious diseases.

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During COVID, people became accustomed to at-home antigen testing using nasal swabs. The process was private, easy to use, and produced results in 15 minutes. But the emergency authorization from the FDA is expected to be withdrawn soon as support for free kits ends. As that door closes, another has opened to allow people to test for other pathogens.

Emeryville-based Lucira Health has applied for FDA approval for the first test that can diagnose not only COVID but also the influenza A and B strains with one sample. It could eliminate the uncertainty of similar symptoms and how to address them while preventing transmission to others.

"You won't be coming into their office infectious. It's better for society," said Lucira Health CEO Erik Engelson. "I'll confess my behaviors in the past were to still go to work, even with the flu. I don't think I'll do that anymore."

Engelson says the device has already been approved for use in Canada. The familiar nasal swab procedure is used after which the testing device amplifies the sample and performs separate flu and COVID assays.

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"Those lab benches are running different tests inside the device, some for flu A, some for flu B and some for COVID."

A high viral load can be confirmed in as fast as 11 minutes, although results more typically take closer to 30 minutes. The device was originally developed to identify sexually transmitted diseases. The vision is to offer a wide range of tests.

"Imagine if you have kids, and you can test for strep at home. Wouldn't that be handy?" said Engelson. "You won't wait until symptoms are severe enough to decide to go to a doctor's office."

Once approved, the Lucira Health test is expected to cost $75 if purchased directly. The cost could be lower if dispensed by a health provider.

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