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Exact Sciences’ Cologuard Gets Panel Nod As Colorectal Cancer Screen

Exact Sciences Corp.’s Cologuard stool test for colorectal cancer screening gained full support from the FDA Molecular and Clinical Genetics Advisory Panel March 27, putting it in a good position to gain approval and, potentially, a Medicare national coverage determination.

Exact Sciences Corp. ’s Cologuard stool test gained unanimous support as a colorectal cancer screening tool from an FDA panel March 27, setting it up for a likely approval and, potentially, a Medicare national coverage determination in the near term.

FDA’s Molecular and Clinical Genetics Advisory Panel said the test was safe, effective, and has benefits that exceed its risks as a screen in adults older than 50 who are...

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First At-Home Cervical Cancer Screening Tool Gets FDA Clearance

 
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Edwards Mitral Valve Replacement System SAPIEN M3 Receives CE Mark

 
• By Natasha Barrow

“We believe [the SAPIEN M3] launch alongside PASCAL and EVOQUE will help support the company’s target of $2bn in transcatheter mitral and tricuspid therapies sales by 2030,” noted analysts from Leerink Partners.

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

 
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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

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