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CLIA Waiver Study Guidelines Simplified By US FDA In Latest Revisions

 
• By Sue Darcey

FDA took the unusual step of issuing a second round of draft guidance documents in its effort to refine requirements for diagnostics companies seeking a CLIA waiver to allow point-of-care use of a test. The revised drafts are simplified compared to November 2017 versions, and they appear to line up more closely with industry arguments about what is needed to demonstrate "accuracy" in this context.

Guidance word in red keyboard buttons

USFDA has returned to the drawing board with some draft advice to in vitro diagnostic device manufacturers on what types of studies are needed to qualify a test for use at the point of care.

Two new draft guidances were postedby the agency Nov

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Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 
• By Natasha Barrow

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 
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Mirvie Launches Predictive Blood Test For Preeclampsia

 
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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.

SpotitEarly Raised $20.3M In New Funding To Bring AI- And Dog-Sniffing-Powered Early Cancer Detection Test To US

 
• By Marion Webb

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SpotitEarly Raised $20.3M In New Funding To Bring AI- And Dog-Sniffing-Powered Early Cancer Detection Test To US

 
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Danaher Faces $350M Tariff Hit, But Says It’s Ready To Absorb The Blow

 
• By Shubham Singh

Despite Danaher’s confident outlook, the company acknowledged near-term profitability fluctuations, particularly in the second quarter. Matt McGrew, Danaher’s CFO, clarified during the company’s first-quarter earnings call on 22 April, that expected operating margin softness in the second quarter – forecast at 25.5% – was not related to tariffs, but to seasonal dynamics in its respiratory diagnostics business.

What’s A Diagnostic? WHO Wants To Know

 
• By Elizabeth Orr

The World Health Organization is seeking input from stakeholders to create an official definition of the term ‘diagnostics.’ This initiative follows a 2023 resolution aimed at enhancing global diagnostics capacity; the definition, it is hoped, will help drive the creation of effective health policies. Comments will be accepted until 23 May.