Receive our newsletter – data, insights and analysis delivered to you
  1. Uncategorised
April 21, 2020

FDA authorises first Covid-19 test for at-home sample collection

By Chloe Kent

The US Food and Drug Administration (FDA) has authorised the first diagnostic test for Covid-19 with a home collection option.

Specifically, the agency has re-issued the Emergency Use Authorisation (EUA) for LabCorp’s COVID-19RT-PCR Test to permit testing of samples collected by patients at home using LapCorp’s Pixel by LabCorp COVID-19 Test home collection kit. Unlike routine PCR tests, which need to be inserted five to ten centimetres into the nasal cavity for a good sample, Pixel is designed to work with a swab taken from the front of the nostril.

LabCorp intents to make the test available to consumers in most US states in the coming weeks, doctor’s note permitting.

FDA commissioner Dr Stephen Hahn said: “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. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”

Related Companies

Content from our partners
Precision wire: The future of bespoke medical treatment
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
“This technique means everything to us”: How CGM devices empower users 

Topics in this article:
NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU