Lab Corp. (LH) announces FDA granted EUA for its Pixel COVID-19 PCR Test Home Collection Kit for ages 2-17
- Wall Street ekes out gains to close languid week
- 'Faster than Porsche but Safer than Volvo': Tesla (TSLA) Begins Model S Plaid Deliveries, Priced Between $131,100 and $145,600
- Oil hits multi-year highs in third weekly gain on demand recovery
- Snowflake (SNOW) Falls Following Investor Day Despite Strong Guidance, Analysts Bullish But Say Investors May Have Wanted More
- Dollar looks stronger as euro and sterling dip
Get inside Wall Street with StreetInsider Premium. Claim your 1-week free trial here.
Labcorp (NYSE: LH), a leading global life sciences company, today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Pixel by Labcorp COVID-19 PCR Test Home Collection Kit for ages 2-17. The authorization expands the use of Pixel by Labcorp to children and adolescents 2 years of age and older when purchased by a parent or guardian.
“Expanding access of our Pixel by Labcorp COVID-19 Test Home Collection Kit to include younger populations fills an important need as people seek to resume life activities safely,” said Brian Caveney, M.D., chief medical officer and president of Labcorp Diagnostics. “This is welcome news as children and parents look forward to summer activities, camps, travel and the upcoming school year.”
Pixel by Labcorp COVID-19 PCR Home Collection Kit uses the same PCR test trusted by doctors and hospitals across the country. Individuals age 14-17 can self-collect with adult supervision, and children between the ages of 2 and 13 will need adult assistance to collect their sample.
Beginning in late May, parents and guardians can request a kit for children 2 years of age and older directly through www.pixel.labcorp.com. Once the request is received by Labcorp, a kit will be shipped to the individual’s home via FedEx. For adults 18 and over, the Pixel by Labcorp COVID-19 PCR Test Home Collection Kit is also available in over 6,000 pharmacies nationwide.
Labcorp offers its Pixel by Labcorp COVID-19 PCR Test Home Collection Kit for zero upfront costs when clinical guidelines are met. Visit Labcorp’s COVID-19 website to learn about the company’s testing and drug development offerings.
The Pixel by Labcorp COVID-19 PCR Test Home Collection Kit has not been FDA-cleared or approved, but has been authorized for emergency use by FDA under an EUA, and has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. Emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Quidel Corp (QDEL) Receives Amended EUA for New Sofia Q Rapid Antigen Test Device
- Rockwell Medical (RMTI) Announces Extension of Multi-Year Distribution Agreement with Nipro Medical Corporation for Dialysis Concentrates
- Zynerba Pharma (ZYNE) Presents Sleep Data from Study of Zygel in Children and Adolescents with Both DEE and ASD at Associated Professional Sleep Societies SLEEP 2021 Annual
Create E-mail Alert Related CategoriesCorporate News, FDA
Related EntitiesTwitter, Earnings, Definitive Agreement, FDA
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!