Quest’s First Pooled Sample COVID-19 Diagnostic Test Could Save Time, Resources: FDA

US regulators gave the thumbs-up to the first COVID-19 test that pools patient samples to determine if any one of the individuals in the pool may be infected. Despite concerns such tests may be diluted and make it harder to detect the SARS-CoV-2 virus, the FDA says validation data shows it works.

BROOKLYN, NEW YORK - DECEMBER 13, 2019: QUEST DIAGNOSTICS brand logo sign at location entrance

Over the weekend the US Food and Drug Administration again authorized Quest Diagnostics Incorporated’s Quest SARS-CoV-2 rRT-PCR test, but this time the authorization is to run multiple tests together to see if a patient within a pool of patients has COVID-19. The agency says the new method should save testing resources and help get results faster.

The agency on 18 July announced it gave emergency use authorization (EUA) for the first COVID-19 diagnostics test that can...

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 Business

Veterinary Heart Health Goes High-Tech: Eko And Boehringer Use AI To Spot Heart Murmurs In Dogs

 
• By 

Eko hopes its new partnership with Boehringer Ingelheim to develop algorithms for accurately detecting heart murmurs in dogs will pave the way for more collaborations with medical and pharmaceutical companies to advance early detection in humans as well as animals.

Prix Galien Spotlights Mental Health ‘Renaissance’ But Systemic Hurdles Persist

 

Experts at the Prix Galien UK Forum discussed the future of mental health innovation, emphasizing the important roles of digital solutions, diagnostic biomarkers and community involvement.

Ellipsis Raises $45M To Expand AI Care Manager Across Health Systems

 
• By 

Ellipsis said it will use its new funding to expand its AI-powered voice assistant Sage across health systems. Ellipsis is part of the global vocal biomarker market, which is expected to exceed $9bn by the end of 2033, according to a research market report.

A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 

After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.

More from Medtech Insight

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

Execs On The Move: 2-6 June 2025

 
• By 

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

Ellipsis Raises $45M To Expand AI Care Manager Across Health Systems

 
• By 

Ellipsis said it will use its new funding to expand its AI-powered voice assistant Sage across health systems. Ellipsis is part of the global vocal biomarker market, which is expected to exceed $9bn by the end of 2033, according to a research market report.