FDA grants emergency approval for Quest Diagnostics's self-collection kit

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FDA grants emergency approval for Quest Diagnostics's self-collection kit

By Sandra Levy - 05/29/2020

Individuals will soon be able to use a self-collection kit to take a nasal specimen for COVID-19. Quest Diagnostics has received emergency use authorization from the Food and Drug Administration for the Quest Diagnostics Self-collection Kit for COVID-19.

The self-collection kit is for individuals to self-collect a nasal specimen at home or in a healthcare setting when determined to be appropriate by a healthcare provider.

The self-collection kit allows an individual to swab the front part of the nostril and may be used on children, who are supervised by an adult, as well as adults. Specimens are shipped overnight via FedEx at room temperature without a frozen cold pack.

Specimens collected using the kit may be tested with the Quest Diagnostics SARS-CoV-2 RT-PCR test that received an Emergency Use Authorization in March. RT-PCR testing aids in diagnosing infection with SARS-CoV-2, the virus that causes COVID-19.

"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, Quest chairman, CEO and president. "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."

"We plan to utilize this device with a range of populations, from state-run programs and employers to healthcare providers and individuals," said Jay Wohlgemuth, Quest senior vice president and chief medical officer. "Our scientists at our advanced diagnostics laboratory in San Juan Capistrano, California developed the technology, which has been validated in real-world studies."

The company plans to make the self-collection kits available through several channels, including for healthcare providers for patient care and healthcare workers as well as for states and organizations 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 will prioritize healthcare workers, first responders, law enforcement personnel and others critical to pandemic response to ensure they have timely access to the kit.

Quest expects to have more than a half-million kits available by the end of June, with plans to make additional kits available on an ongoing basis.