FDA approves Quest Diagnostics’ new coronavirus home test kit

The FDA last week approved Quest Diagnostics’ new coronavirus testing kit, which will allow individuals to perform COVID-19 testing in their homes. After the user obtains the sample through the nasal swab, the user can send the sample overnight to the testing laboratory, and they will receive their test results. After approval, Quest Diagnostics said it plans to provide half a million test kits by the end of June.

FDA approves Quest Diagnostics' new coronavirus home test kit

Approval of new test kits is important because the lack of extensive testing has been a long-standing problem. Without extensive new coronavirus testing, it can be more challenging to determine the full impact of the virus and whether the number of cases is rising or decreasing. More importantly, available tests help ensure that asymptomatic infections are found — or they won’t realize they’re infected with the virus — to take appropriate safety precautions.

“COVID-19 molecular diagnostic testing has been limited, in part because of the limited supply of cotton swabs and the inability of trained medical staff to collect specimens,” Steve Rusckowski, chief executive of Quest Diagnostics, said in a press release. “Self-collection kits allow individuals to self-collect at home, and the process is much more comfortable than many traditional methods. “

Quest Diagnostics says it plans to make its test kits “used in a range of people.” The company will provide for state-run health plans, health care providers and, of course, individuals.

The company highlighted some of the key features of the new test suite:

Individuals collect themselves at home and use consumer-friendly nasal swabs for testing

Use its extensive logistics network to ship goods overnight to individuals via FedEx and back to Quest Diagnostics.

Specimens are transported at room temperature and do not require ice packs.

Children under the age of 18 are eligible to participate (under adult supervision).

Report results through the myQuest patient portal and mobile app.

Test data is reported to the relevant health department as required by Quest Diagnostics.

Interestingly, fda approval of test kits came faster than usual because the agency approved it through the Emergency Use Authorization (EUA). While the FDA’s standard approval process is usually fairly rigorous, a rule passed by Congress decades ago allowed the agency to approve test kits in an emergency if it could help “diagnose, treat, or prevent serious or life-threatening diseases or symptoms.”