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Monday, Oct 3, 2022

FDA Approves Fulgent Virus Tests

Temple City-based genetic testing firm Fulgent Genetics Inc. is joining the rush of companies with home-based Covid-19 tests, announcing the launch of its service after receiving emergency authorization approval from the Food and Drug Administration.

The company said June 16 its Covid-19 test will use Picture Genetics, the at-home genetic testing platform it launched last summer.

Fulgent’s stock jumped 10% in after-market trading following the June 16 announcement, but gave back that overnight gain and fell an additional 1% on June 17, to close at $16.33, down 17 cents from its June 16 close.

In late March and early April, Fulgent entered the Covid-19 testing market with two kits it distributed to testing centers and clinics, according to comments from Chief Executive Ming Hsieh during the company’s most recent earnings call.

The test kit released in early April uses conventional reverse transcription polymerase chain reaction technology, analyzing RNA samples collected from nose and throat swabs to determine if the virus is present.

The other test, released in late March, uses a newer, analytic technique that Hsieh called next-generation sequencing. This test is aimed at researchers trying to get a better understanding of the coronavirus and Covid-19 disease.

According to Fulgent, its home-based genetic test offers at-risk individuals a more convenient way of getting tested for Covid-19 than the drive-up sites or walk-in clinics that have been established around the country.

“We are pleased to be able to offer a convenient and readily available Covid-19 testing solution for individuals at risk of contracting the virus,” Brandon Perthuis, Fulgent’s chief commercial officer, said in the announcement.

“Options for testing remain limited and many eligible individuals are unable to get the testing they need. We believe our at-home testing service will both enable at-risk individuals, particularly those at the front lines of this pandemic, to more readily access testing solutions while potentially offering a solution for organizations to screen employees before they return to work,” Perthuis added.

Individuals seeking at-home coronavirus testing must qualify through an online eligibility screener, which uses Centers for Disease Control guidelines to prioritize those who are most in need of testing.

Eligible individuals will receive Fulgent’s test kit in the mail, including a nasal swab. Once they collect their sample, they mail it to Fulgent’s lab in Temple City. Results are emailed through the company’s Picture Genetics platform within 48 hours of the lab receiving the sample.

Fulgent is joining several companies offering at-home Covid-19 tests, according to Ahmed Enany, chief executive of the Southern California Biomedical Council, an industry group based in downtown. Among these companies, he said, are Burlington, N.C.-based Laboratory Corp. of America Holdings; San Francisco-based Vitagene Inc. and downtown-based Scanwell Health Inc. .

“The availability of at-home diagnostic kits — even if it takes a couple of days to get the results — provides more options for people to get tested at a time when testing supplies are still tight at medical institutions,” Enany said.

Howard Fine
Howard Fine
Howard Fine is a 23-year veteran of the Los Angeles Business Journal. He covers stories pertaining to healthcare, biomedicine, energy, engineering, construction, and infrastructure. He has won several awards, including Best Body of Work for a single reporter from the Alliance of Area Business Publishers and Distinguished Journalist of the Year from the Society of Professional Journalists.

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