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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Saliva-Based Endometriosis Test Shows 96% Accuracy
The test uses microRNA analysis and AI to diagnose endometriosis in women with chronic pelvic pain when imaging is inconclusive.
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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.
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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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Blood Test May Match CT for Early Lung Cancer Detection
The Mercy Halo test demonstrates performance similar to low-dose CT screening with the potential to reach underscreened populations.
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