Secaucus-based Quest Diagnostics received U.S. Food and Drug Administration (FDA) emergency use authorization (EUA) for its self-collection kit for COVID-19.
The kit allows individuals to self-collect nasal SARS-CoV-2 test specimens either at home or at a health care setting. Individuals collect samples by swabbing the front part of their nostrils. The kit and is intended for use in adults and children under adult supervision. Samples can then be shipped overnight to a Quest lab facility at room temperature.
As the U.S. tries to expand its testing capacity, at-home testing is seen as an important modality to get more people tested.
Quest said it will have more than 500,000 kits available by the end of June.
Earlier this month Rutgers University’s RUCDR Infinite Biologics received an amended EUA for its SARS-CoV-2 test to allow individuals to collect their own saliva sample at home and send it to the lab for testing.
“COVID-19 molecular diagnostic testing has been constrained partly by limited supplies of swabs and trained health care professionals to do the specimen collection,” Steve Rusckowski, Quest’s chairman, chief executive officer and president, said in a statement. “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.”