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Quest Diagnostics Receives FDA Emergency Use Authorization for COVID-19 Self-Collection Test Kit

NEW YORK – Quest Diagnostics said on Thursday that it has received US Food and Drug Administration Emergency Use Authorization for its Self-collection Kit for COVID-19.

The kit allows individuals to self-collect nasal SARS-CoV-2 test specimens either at home or a healthcare setting for testing with Quest's SARS-CoV-2 RT-PCR test, which received FDA EUA in mid-March.

Individuals collect samples by swabbing the front part of their nostrils. The kit and is intended for use in adults and children under adult supervision. Samples can then be shipped overnight to a Quest lab facility at room temperature.

The company said it plans to make the kits available through healthcare providers for their patients and to healthcare workers and through states and other organizations running return-to-work testing programs with priority given to healthcare workers, first responders, law enforcement personnel, and other workers playing a role in the pandemic response. Eventually, kits will also be made available to individual customers through Quests' QuestDirect platform.

Quest said it will have more than 500,000 kits available by the end of June.

"COVID-19 molecular diagnostic testing has been constrained partly by limited supplies of swabs and trained healthcare professionals to do the specimen collection," Steve Rusckowski, Quest's chairman, CEO and president said 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."

As the US tries to expand its coronavirus testing capacity, at-home testing is seen as an important modality to get more people tested, and today's announcement follows the recent clearance by the FDA of an at-home swab collection kit by Everlywell. In April the agency reissued an EUA to the Laboratory Corporation of America to allow for the self-collection of samples by patients using LabCorp's Pixel by LabCorp COVID-19 Test home collection kit. Earlier this month Rutgers University's RUCDR Infinite Biologics received an amended EUA for its SARS-CoV-2 test to allow individuals to collect their own saliva sample at home and send it to the lab for testing.

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