Foundation Medicine Reaches 100 Approved Companion Diagnostic Indications
The precision medicine company now has 57 approvals in the US and 43 in Japan for its FoundationOne CDx and FoundationOne Liquid CDx tests.
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FDA Proposes Reclassifying Oncology Nucleic Acid–Based Tests from Class III to Class II
The proposed order would shift these test systems to Class II with special controls, replacing the current PMA requirement for companion diagnostics and related oncology assays.
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Every week, we dig into the biggest shifts, breakthroughs, and tech transforming clinical diagnostics. Straightforward, insightful, and always relevant.Critical Resources
Diagnostic Innovations
New ‘Ultra-Mild’ Sequencing Method Addresses DNA Methylation Testing Limitations
UMBS-seq preserves DNA integrity while maintaining accuracy for cancer biomarker detection in liquid biopsies and tissue samples.
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Comprehensive Liver Health Management: Top Platforms for Health Care Organizations
Compare leading liver health management platforms that support early detection, streamline clinical workflows, and improve outcomes for patients with liver disease.
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Disease Detection & Understanding
FDA Approves Blood-Based Prostate Cancer Test
The test receives premarket approval as an aid in biopsy decision-making for men 50 and older with elevated PSA levels.
