1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Legislation

Faulty CDC COVID-19 Assays Leave Only 12 US Jurisdictions With Testing Ability, CDC Director Says

But better reagent coming, Robert Redfield tells congressional panel

 
• By Sue Darcey

Only 12 US jurisdictions currently have sound COVID-19 virus assays from the Centers for Disease Control and Prevention to test suspected virus cases, CDC director Robert Redfield told a House panel looking at virus preparedness on Wednesday – but a better batch is coming, he said. Other questions raised at the congressional hearing was how long an infected person stays infected, whether COVID-19 can be picked up from inanimate surfaces, and related queries.

microbiologist with a tube of biological sample contaminated by Coronavirus with label Covid-19 / doctor in the laboratory with a biological tube for analysis and sampling of Covid-19 infectious disea

The US Centers for Disease Control and Prevention worked with the Food and Drug Administration to fix faulty COVID-19 assays it previously sent to all 50 state laboratories, with the result that new, improved test reagents will be sent back next week to states that need it, CDC director Redfield told Congress on 26 February.

The CDC first reported glitches in some of the tests that were sent out two weeks ago, leaving only 12 laboratories in the US with adequate diagnostics to detect freshly...

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
Start Free Trial

Already a subscriber?

More from Legislation

Debate On FDA User Fee Reauthorization Begins To Take Shape

 
• By Elizabeth Orr

A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.

Health Secretary Defends Spending Cuts During Senate Hearing On HHS Budget

 
• By Elizabeth Orr

Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.

Tariffs Threaten Medtech Innovation And US Position As World Leader, Whitaker Tells Lawmakers

 
• By Brian Bossetta

During his testimony before US senators on the impact of tariffs on critical supply chains, AdvaMed’s Scott Whitaker said the Trump tariffs could jeopardize America’s preeminence in medtech. Other industry experts echoed similar concerns.

‘The FDA Will Be Looking For Avenues To Regulate Laboratory Developed Tests’

 
• By Natasha Barrow

The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.

More from Policy & Regulation

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
• By Amanda Maxwell

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 
• By Natasha Barrow

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