Quest lands FDA nod for at-home COVID-19 test

Quest Diagnostics (NYSE:DGX) has received an FDA emergency use authorization (EUA) for an at-home diagnostic test for COVID-19.

The Secaucus, N.J.-based testing giant said the test 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. It allows an individual to swab the front part of the nostril and may be used on children (supervised by an adult) as well as adults. Specimens are shipped overnight via FedEx at room temperature and patients can obtain results through the myQuest patient portal and mobile app. Quest said it will report test data to the relevant departments of health as required.

Specimens collected using the kit may be tested with the Quest Diagnostics SARS-CoV-2 RT-PCR test that received an EUA 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 Quest Diagnostics president & CEO Steve Rusckowski in a news 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.”

“We plan to utilize this device with a range of populations, from state-run programs and employers to healthcare providers and individuals,” added Dr. Jay G. Wohlgemuth, Quest’s 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.”

Quest Diagnostics already tested specimens using a similar collection method in real-world settings in drive-thru and other onsite COVID-19 testing sites across the United States. 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 said it will 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.