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 use pooled samples

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

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.

Regeneron Sees 23andMe Buy As Complement To Genetics Platform - Clone

 

The consumer genomics firm will operate as a subsidiary, while Regeneron plans to leverage its database for drug discovery and trial design efforts.

Disparities — Including Financials Shortcomings — Remain In Women’s Health, Execs Say

 

FemTech leaders discussed some of the barriers that remain in unlocking the full potential of the women’s health market during SiS New York last week. They also offered solutions.

Mirvie Launches Predictive Blood Test For Preeclampsia

 
• By 

Mirvie launched Encompass, a blood test to help identify women over age 35 who are at moderate risk for preeclampsia, and will conduct additional studies to support reimbursements from payers.

More from Medtech Insight

Mirvie Launches Predictive Blood Test For Preeclampsia

 
• By 

Mirvie launched Encompass, a blood test to help identify women over age 35 who are at moderate risk for preeclampsia, and will conduct additional studies to support reimbursements from payers.

Bringing Israeli Medical Device Candidates To The Right Partners In The US

 
• By 

Despite regional unrest, it is business as usual for medtech innovators and investors in Israel as evidenced by continued high-value M&A of locally developed technologies. Irit Yaniv, co-chair of the medtech session at the upcoming BioMed Israel 2025, explained the unique dynamics of Israeli medtech innovation.

How Structured Patient Engagement Gives Medtech Companies A Competitive Edge

 

Communication with patients has become a particularly crucial factor for investors, payers, and other healthcare decision-makers in a hostile market environment.