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FDA Pulls Chembio’s Rapid Test As Purge Of ‘Inaccurate’ Antibody Tests Continues

 
• By Phil Greenfield

Chembio’s stock opened down 60% the day after the FDA’s decision to revoke its EUA for the first US rapid test for antibodies to SARS-CoV-2.

FDA alert to Abbott’s COVID-19 test that doesn’t perform as expected

The US Food and Drug Administration has revoked the emergency use authorization (EUA) of Chembio Diagnostics Inc.’s DPP COVID-19 IgM/IgG test and analyzer system due to doubts about the accuracy of the test. The test was the first rapid test for antibodies to SARS-CoV-2 authorized for use in the US.

The news prompted a sell-off in Chembio’s shares, with the price plummeting around 60% in premarket trading, opening at $3.86 on 17 June. That suggests the news was a big...

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More from United States

Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

Bone Surgery Startup Surgify Medical Raises $7.9m

 
• By Natasha Barrow

Surgify Medical’s selective drill tip, Surgify Halo, is “an obvious choice for surgeons,” said Boris Hofmann, head of ZEISS Ventures and lead investor in the company’s series A funding round.

German Bionic Launches ‘Strongest Exoskeleton To Date’

 
• By Natasha Barrow

German Bionic’s new exoskeleton Exia helps healthcare practitioners, nurses, and other caregivers to lift and move patients by supporting muscle movement and reducing the risk of injury.

FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By Elizabeth Orr

The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.

More from North America

TRiCares Tricuspid Valve Replacement System Reduces Regurgitation In First-In-Human Study

 
• By Natasha Barrow

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Guardant Health Launches Germline Hereditary Cancer Test

 
• By Natasha Barrow

Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.

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.