UK Variant Of Coronavirus May Be Harder To Diagnose With Many Current Tests: FDA

The agency is cautioning that current tests may give false negative results for patients with genetic mutations of SARS-CoV-2, making it harder to control the spread of the pandemic.

Illustration of a coronavirus cell mutating.

The US Food and Drug Administration alerted clinical laboratories and health care providers that mutations in the SARS-CoV-2 virus, including the B.1.1.7 variant, may result in false negative readings on molecular diagnostic tests for COVID-19 .

The B.1.1.7 variant was discovered first in the UK back in October and is far more contagious than previous variants of the virus. Since the pandemic began, the FDA has...

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 Regulation

More from Policy & Regulation

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By 

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT Ruling

 
• By 

A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.

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

 
• By 

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.