Quest’s self-swab COVID test gets FDA authorization

Secaucus-based Quest Diagnostics announced on Thursday it has received emergency use authorization by the Food & Drug Administration to release its self-collection kit for COVID-19.

The lab-developed test will be available for people to self-collect a nasal specimen at home or in a health care setting when its determined necessary by a health care provider.

Each specimen will be shipped overnight via FedEx at room temperature and may be tested with the Quest Diagnostics SARS-CoV-2 RT-PRC test that received emergency use authorization in March, which helps diagnose 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,” Steve Rusckowski, chairman, CEO and president, said. “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 said it has already tested samples using a similar collection method at various drive-thru and on-site testing facilities throughout the United States.

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

Other features of the kit include:

  • Self-collection at home with a consumer-friendly nasal swab;
  • FedEx overnight shipping to the individual and back to Quest Diagnostics;
  • Specimens shipped at room temperature so no need for ice;
  • Can be used on children less than 18 years of age with supervision;
  • Results posted on the myQuest patient portal and mobile app;
  • Test data sent to the relevant departments of health as required.

The company said it will be prioritizing the kits for health care workers, first responders, those in law enforcement and others related to the pandemic response to ensure they have access to them.

More than 500,000 kits will be available by the end of June, with plans for additional ones on an ongoing basis.

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