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Foundation Adds New Markers To FoundationOne Cancer Testing Platform

 
• By Reed Miller

US FDA and the Centers for Medicare and Medicaid Services have already accepted FoundationOne for Parallel Review and Expedited Access for breakthrough devices. The new markers will help identify patients best-suited to immunotherapy or other targeted therarapies, the company says.

Foundation Medicine Inc. is adding fully integrated and validated assessments of tumor mutational burden (TMB) and microsatellite instability (MSI) to its FoundationOne solid-tumor genomic test, and FoundationOne Heme hematologic and sarcoma molecular diagnostics systems to help oncologists identify the best therapies for their advanced-stage cancer patients.

The tests can easily be incorporated into the same genomic test report that FoundationOne and FoundationOne Heme already produce without requiring additional cost or time, according to Vince Miller, Foundation...

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• By Marion Webb, Brian Bossetta, Natasha Barrow, and Elizabeth Orr

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Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
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Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By Marion Webb

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Siemens Healthineers Widens FY25 EPS Range By €0.15 To Absorb Up To €300M In Tariff Costs

 
• By Shubham Singh

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