Quest Diagnostics' self-collection COVID-19 test kit gets FDA nod for emergency use

coronavirus test tubes
Quest Diagnostics said it will make its test kits available to healthcare providers, states and employers for return-to-work testing programs. (Getty/RossHelen)

Quest Diagnostics received emergency use authorization for its self-collection COVID-19 test kit from the FDA.

The company intends more than a half-million test kits to be available by end of June, with plans to make additional kits available on an ongoing basis, the company said Thursday. The news sent Quest's shares up 3%, Reuters reported.

Quest plans to make the device available through a broad range of healthcare, state, employer and consumer-initiated channels.

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The test kit was designed for self-collection by individuals, at home, with a consumer-friendly nasal swab approach, the company said.

Diagnostic and medical device companies have raced to develop at-home test kits for COVID-19 to expand testing capacity for the virus. LabCorp received a green light from the FDA back in April for its first at-home test for COVID-19. The FDA also issued emergency authorizations for a saliva-based test developed by Rutgers University and an at-home collection kit from home health care testing company Everlywell.

Startups Hims & Hers and Vault Health also rolled out FDA-authorized COVID-19 testing kits to order online and administer at home based on the Rutgers University saliva test.

Quest said specimens collected using the kit may be tested with the company's SARS-CoV-2 RT-PCR test that received an emergency authorization in March. This test aids in diagnosing infection with SARS-CoV-2, the virus that causes COVID-19.

RELATED: FDA clamps down on at-home coronavirus testing, citing fake products and bad actors

The company will also make the test kits available to healthcare providers, states and employers for return-to-work testing programs.

Over time, the kits may also be made available to other employers as well as for individual users of the company's QuestDirect consumer-initiated platform. The company plans to prioritize healthcare workers, first responders, law enforcement personnel and others critical to pandemic response to ensure they have timely access to the kit.

"COVID-19 molecular diagnostic testing has been constrained partly by limited supplies of swabs and trained healthcare professionals to do the specimen collection," said Steve Rusckowski, chairman, CEO and president of Quest, in a statement. "The self-collection kit enables an individual to self-collect at home, and the process is far less invasive and uncomfortable than many traditional methods."

Quest Diagnostics said it already tested specimens using a similar collection method in real-world settings in drive-thru and other on-site COVID-19 testing sites across the U.S.

RELATED: Hims & Hers, Vault Health roll out at-home saliva COVID-19 tests

The company also rolled out this week a new suite of Return to Work services built around large-scale workforce COVID-19 testing. Those services feature access to COVID-19 diagnostic and antibody testing and related capabilities, from event staffing to digital results reporting, the company said.

"Given our relationships with thousands of employers, we feel Quest can make a major contribution with our Return to Work services. We will empower organizations of all sizes to use lab insights to help them foster safer and healthy environments as our nation plans to reopen our economy," said Rusckowski in a statement.

The company is scaling up its COVID-19 lab operations. The company expects to have the capacity to perform approximately 150,000 molecular diagnostic tests a day by the end of June, compared to approximately 80,000 of these tests a day currently. Quest also has the capacity to perform approximately 200,000 antibody tests a day.

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