The FDA is looking to add more tests to its list of authorized, home-based coronavirus diagnostics following its recent green lights for lab testing giant Quest Diagnostics and direct-to-consumer company LetsGetChecked.
The agency published a new template specifically for developers of self-collected tests—similar to previous documents for molecular, antibody and antigen diagnostics—outlining the data and information needed when requesting an emergency use authorization.
Following an earlier crackdown on offerings of home-based tests, the FDA has since authorized several COVID-19 diagnostics enabling the self-collection of samples, via either saliva or a nasal swab, which are then shipped to a laboratory for processing. Currently, there are no tests authorized to completely perform the analysis at home or outside of a professional setting.
“During this pandemic, the FDA has remained supportive of making accurate and reliable tests widely available,” said Jeff Shuren, director of the FDA’s device center, in an agency statement.
“Home collection raises unique concerns about safety and accuracy—for example, can the sample be collected safely and properly by a layperson, can the sample be shipped in a way that’s stable to ensure an accurate result once it reaches the lab, among other factors—which is why these tests require FDA review, to ensure they work as they should and are safe for all involved,” Shuren said.
“An at-home test that returns false results could be harmful to an individual patient, and hinder broader public health efforts to mitigate the spread of COVID-19,” he added. “We’ll continue to support ways of making our review processes as streamlined as possible, while continuing to protect patients and the public health.”
Late last week, the FDA authorized Quest’s self-collection nasal swab kit for use with the company’s molecular test the agency OK’d in March. It allows a person to take a sample from the front part of their nostril, compared to previous nasopharyngeal swabs that needed to reach deep into the recesses of the nose. The sample is then shipped overnight at room temperature.
The company said it plans to offer the kit for use in adults and children as well as to state-run public health programs and employers in the workplace, with priority given to healthcare workers and first responders.
"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's chairman, president and CEO Steve Rusckowski, who described the process as less invasive and uncomfortable compared to past testing methods. Quest expects to have more than 500,000 kits available by the end of June.
For its home-based diagnostic, LetsGetChecked is aiming to turn around results alongside a 24/7 telehealth platform offering guidance following a positive test. The company’s Sure-track Test also includes a transport tube containing a solution that deactivates the virus, compared to other tests that may use a saline solution.
“The coronavirus crisis has impacted everyone and we are delighted to not only introduce a reliable testing solution, but one that is safe for everyone involved in the supply chain,” said Gwen Murphy, director of epidemiology and clinical studies at LetsGetChecked.
“Our entire system was considered as part of the review process and we are delighted to have worked with the FDA to deliver a truly unique at-home coronavirus testing service to our customers,” Murphy said. “At-home testing will play a central role in ensuring a safe workplace and we are helping to develop and inform protocols with that in mind.”