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FDA approves an at-home coronavirus testing kit

The FDA this week approved a coronavirus testing kit from Quest Diagnostics that will allow individuals to test themselves for COVID-19 from the comfort of their own home. After taking a swab from their nostril, users can then FedEx the sample overnight to a testing lab whereupon they’ll receive their results. In the wake of the approval, Quest Diagnostics said it’s planning to 500,000 kits ready to send out by the end of June.

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The approval of the new testing kits is significant because a lack of widespread testing has been a longstanding issue. Without expansive coronavirus testing, it becomes that much more challenging to ascertain the full impact of the virus and whether or not the number of cases are rising or falling. More importantly, accessible testing helps ensure that asymptomatic coronavirus patients — who would otherwise be unaware that they have the virus — take appropriate safety precautions.

“COVID-19 molecular diagnostic testing has been constrained partly by limited supplies of swabs and trained healthcare professionals to do the specimen collection,” Quest Diagnostics CEO Steve Rusckowski said in a press release. “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 plans to make its testing kits available across a “range of populations,” which is to say it will be available for state-run health programs, healthcare providers, and of course, individuals.

The company highlighted a few of the key features of the new testing kits, which you can see below:

  • Self-collection by individuals, at home, with a consumer-friendly nasal swab approach
  • Overnight shipping to the individual and back to Quest Diagnostics with FedEx, leveraging their extensive logistics network
  • Specimens shipped at room temperature, which eliminates the need for ice packs
  • Availability for children less than 18 years of age (with adult supervision)
  • Results reporting through the myQuest patient portal and mobile app
  • Test data reported by Quest Diagnostics to the relevant departments of health as required.

Interestingly, the FDA approval for the testing kits came in faster than it would ordinarily as the agency approved it via an Emergency Use Authorization (EUA). Though the standard FDA approval process is typically quite stringent, a provision passed by Congress decades ago allows the agency to green light “unapproved uses of approved medical products” in emergency situations if it can help “diagnose, treat, or prevent serious or life-threatening diseases or conditions…”

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