LabCorp's at-home coronavirus testing kit authorized by FDA

coronavirus test tubes
LabCorp said it plans to make the test available with a prescription in the coming weeks, starting with front-line healthcare workers and first responders. (Getty/RossHelen)

The FDA has given the green light to its first at-home test for COVID-19, allowing people to collect nasal swab samples themselves and then ship them to a clinical laboratory to be analyzed for signs of the novel coronavirus.

SPECIAL REPORT: FierceMedTech's 2019 Fierce 15

Offered by LabCorp, the Pixel test is built off the coronavirus diagnostic that received an FDA authorization in early March, forming the basis of its nationwide testing service. The new home kit includes specifically designed swabs that only have to go as far as the nostril, as opposed to the deeper nasopharyngeal swabs used in previous tests.

Free Webinar

From Patient Adherence to Manufacturing Ease - Why Softgels Make Sense for Rx

Join Thermo Fisher Scientific’s upcoming webinar to learn why softgels offer numerous benefits for Rx drug development, including enhanced bioavailability, patient compliance and easy scale-up. Register Today.

Those swabs must reach farther back into the nose’s upper cavities to collect a clean sample—a difficult and uncomfortable procedure that requires a trained healthcare professional—which had been a hindrance to the development of home-based tests.

The kit also includes an ice pack, insulation and a FedEx box for overnight shipping. LabCorp said it plans to make the test available with a prescription in the coming weeks for $119, starting with front-line healthcare workers and first responders. Results will typically take one to two days.

RELATED: FDA clamps down on at-home coronavirus testing, citing fake products and bad actors

“The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more than 50 diagnostic tests and engagement with over 350 test developers,” FDA Commissioner Stephen Hahn said in a statement

“Specifically, for tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site,” Hahn added.

Suggested Articles

Biotech IPOs are up over 40% year-to-date, but today’s markets have rewritten the rules for going public. Find out the new best practices for IPOs.

Baxter has received clearance from the FDA for the latest version of its automated peritoneal dialysis system designed for home use.

ATAI Life Sciences is topping off a busy year with a $125 million financing, which will push two programs through phase 2 readouts.