The U.S. FDA granted an emergency use authorization (EUA) for Quest Diagnostics Inc.’s self-collection kit for COVID-19. The kit allows individuals to collect their own specimens at home or in a health care setting.
"COVID-19 molecular diagnostic testing has been constrained partly by limited supplies of swabs and trained healthcare professionals to do the specimen collection," said Steve Rusckowski, Quest’s chairman, CEO and president. "The ... kit enables an individual to self-collect at home, and the process is far less invasive and uncomfortable than many traditional methods."
The greater comfort comes from the combination of the home setting and the ability to collect a sample from the front of the nostril rather than the back, as has been the case in other tests.
Analyses of other molecular tests have shown that errors in specimen collection and other issues have produced relatively low reliability of results, but the company seemed confident of the value of its new product, even with untrained individuals collecting samples.
“The kit is similar to the molecular PCR testing [that] we currently provide, but the specimen can be collected by the patient without medical supervision,” Quest Senior Vice President and Chief Medical Officer Jay Wohlgemuth told BioWorld.
“Quest shared data with [the] FDA that indicate that the self-collection kit offers a consumer-friendly approach to high-quality diagnostic testing for COVID-19,” he added.
The kit will be used in offices and drive throughs, as well as for home collection by consumers.
Samples are sent overnight for processing using Quest’s SARS-CoV-2 RT-PCR test, which received its own EUA in March.
The samples do not require refrigeration or use of a cold pack for preservation in shipment. “We are working with our carrier, FedEx, to ensure proper shipping temperatures,” Wohlgemuth said.
While Laboratory Corp. of America Holdings claims the prize for being first to have an authorized at-home COVID-19 test, having received an EUA for its test in April, Quest’s test still enters a market with huge appetite and need for testing.
In early May, Harvard’s Global Health Institute suggested that the U.S. should be conducting 900,000 diagnostic tests per day to reopen. In late April, another group at the university said the country needed to do 5 million tests a day by early June, rising to 20 million by the end of that month to fully reopen.
“We’re planning to ramp this up by end of June, with the goal of 500,000 kits available,” said Wohlgemuth.
The company did not provide information about plans to increase production in subsequent months; however, it said that it expects to continue to produce additional kits on an ongoing basis.
"We plan to utilize this device with a range of populations, from state-run programs and employers to health care providers and individuals," Wohlgemuth said.
Return to work suite
Along with the kit, Quest announced a new Return to Work package of services for employers as states reopen.
"All of us are eager to get back to work as safely as possible, and COVID-19 testing is essential to making this happen," said Rusckowski.
The new suite of services will include large-scale workforce diagnostic and antibody testing for COVID-19, as well as an ability to act on lab insights to increase safety in the workplace. The program also will offer on-site temperature and respiratory checks, blood specimen collection, online questionnaires to evaluate symptoms and exposure, access to physician ordering and telemedicine services, and, eventually, vaccination services.
As part of that program, Quest is adding more capacity to enable it to conduct 150,000 molecular diagnostic tests a day within a month, about double its current capacity. Quest already can process 200,000 antibody tests per day.
"Employers of all kinds are trying to put programs in place to help protect their employees and customers as we return to work over the coming months. To be more effective, these programs will need to use high-quality laboratory-based testing with software applications and analytics along with implementation of worksite safety programs," said Wohlgemuth, who also heads Quest's Employer Population Health business.
"Every workforce has different testing needs depending on the local environment, the type of work, the work environment and interactions with customers for the job category. Our Return to Work solution can be tailored to each organization's unique requirements," he noted.
The company plans to prioritize offering the new suite of services to companies that provide essential services.