COVID-19 Update: FDA Authorizes First At-home Collection Kit

Morrison & Foerster LLP - Class Dismissed

FDA has been actively working to accelerate access to diagnostic tests for COVID-19 through its extension of Emergency Use Authorizations (EUAs). According to FDA Commissioner Stephen M. Hahn, M.D., “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.”

Still, as we previously reported, no diagnostic test had been authorized for at-home collection by Americans. But that changed last Tuesday when FDA authorized the first diagnostic test with an at-home collection option for COVID-19. Specifically, the agency re-issued an EUA for the Laboratory Corporation of America’s (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home.

Importantly, the EUA is not a general authorization for at-home tests fully conducted at home. Instead, the EUA permits at-home collection using LabCorp’s designated self-collection kit, which contains nasal swabs and saline. Once patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing. LabCorp intends to make these kits available to consumers in most states (with a doctor’s order) within the coming weeks.

FDA worked with LabCorp to ensure that at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital, or other testing site. FDA encourages developers to discuss their validation of home use or self-collection tests with the agency early in their development process.

To that end, while the LabCorp self-collection kit includes a specific nasal swab and may not be used with other cotton swabs at the present time, FDA is working with test developers to determine whether or not Q-tip-style cotton swabs can be used safely and effectively with other tests.

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Morrison & Foerster LLP - Class Dismissed | Attorney Advertising

Written by:

Morrison & Foerster LLP - Class Dismissed
Contact
more
less

Morrison & Foerster LLP - Class Dismissed on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.