FDA Authorizes First Direct-To-Consumer COVID-19 Sample Collection Kit

LabCorp’s Pixel COVID-19 test home collection kit will be available over the counter through LabCorp’s website.

Microscopic view of Coronavirus, a pathogen that attacks the respiratory tract. Analysis and test, experimentation. Sars. 3d render
• Source: shutterstock.com

LabCorp's Pixel COVID-19 test home collection is the first COVID-19 test sample collection kit available in the US without a prescription. The US Food and Drug Administration granted the kit an emergency use authorization on 9 December.

The Pixel kit allows any adult to self-collect a nasal swab sample at home and send it to LabCorp to be tested with LabCorp’s a real-time reverse transcription polymerase chain...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from In Vitro Diagnostics

More from Diagnostics

Cardiosense Advances Noninvasive Heart Monitoring With Final Validation Study

 
• By 

Cardiosense has launched a nationwide clinical study, SEISMIC-HF II, to validate its non-invasive, AI-powered technology for monitoring heart failure. The data will be used to file for US regulatory clearance of the Cardiosense heart failure monitoring platform.

Handheld Diagnostics: A Resurging Category That is Here to Stay

 

Handheld diagnostics are more powerful, accessible and clinically relevant than ever. Medtech Insight spoke to companies behind such technologies to learn how they work and discuss their commercial models.

Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 

Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.