Flow Cytometry Blood Test for Myeloma MRD Detection Launches
The test offers sensitivity comparable to next-generation sequencing methods while using noninvasive blood specimens instead of bone marrow aspirates.
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Guardant Health, Merck Form Multi-Year Partnership for Cancer Companion Diagnostics
The collaboration will utilize Guardant’s liquid biopsy portfolio for the development of companion diagnostics for drug approvals.
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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.
Read MoreAI Diagnostic Applications Showcased at AMP 2025 Annual Meeting
Studies demonstrate artificial intelligence achieving 93% cancer diagnostic accuracy and enabling noninvasive tumor analysis through spinal fluid testing.
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ASCP Launches Analytics Platform for Laboratory Performance Benchmarking
Performance and Diagnostics Insights platform provides comparative analytics to help labs optimize operations and improve patient care.
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