The Temple City, CA-based company received EUA from FDA for the test and will offer it through Picture Genetics, the company’s consumer-initiated genetic testing platform.

Omar Ford

June 17, 2020

2 Min Read
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Markus Mainka -stock.adobe.com

Fulgent Genetics is launching an at-home testing solution for the coronavirus. The Temple City, CA-based company received emergency use authorization from FDA for the diagnostic, which tests for SARS-CoV-2 the virus that causes COVID-19.

Fulgent said it will be offering the testing service through Picture Genetics, the company’s consumer-initiated genetic testing platform, beginning next week.

Individuals interested in ordering testing services must qualify for the service through an online eligibility screener, which makes eligibility determinations based on the current Centers for Disease Control and Prevention guidelines while prioritizing those who are most in need of testing.

The company said eligible individuals will receive Fulgent’s collection materials in the mail that enable them to self-collect their specimens with a mid-turbinate nasal swab.  The specimen will be sent back to its Clinical Laboratory Improvement Amendments-certified high-complexity, CAP-accredited laboratory in Temple City, CA.

By enabling individuals to collect samples themselves, Fulgent’s at-home test services conserve valuable time and PPE resources otherwise required to perform these testing services for patients. Patients will receive their results through the Picture Genetics platform within 24 to 48 hours from receipt of the sample.

“As the coronavirus continues to spread, options for testing remain limited and many eligible individuals are unable to get the testing they need,” said Brandon Perthuis, Chief Commercial Officer at Fulgent Genetics in a release. “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 as they return to work.”

Labcorp was one of the first companies to obtain EUA for a test with a home collection option for COVID-19.  

Fulgent’s at-home test comes as there are more than 2,2 million confirmed coronavirus cases in the U.S., according to worldometers.info. About 119,175 people have died from the disease and about 903,136 have recovered.

 

About the Author(s)

Omar Ford

Omar Ford is MD+DI's Editor-in-Chief. You can reach him at [email protected].

 

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