Lyme Disease Test Granted FDA Breakthrough Device Designation
The test detects Borrelia bacteria directly from skin samples at tick bite sites.
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Large-Scale Study Validates Multi-Cancer Blood Test Performance
A real-world study of 111,080 participants found the Galleri multi-cancer blood test achieved a 0.91% cancer detection rate and 87% accuracy in predicting tumor origin.
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FDA Approves Companion Diagnostic for Colorectal Cancer Treatment
The FDA has approved a companion diagnostic for identifying BRAF V600E-mutant metastatic colorectal cancer patients eligible for encorafenib combination therapy.
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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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New Method Shows Superior Sensitivity in Liquid Biopsy Testing
Bridge Capture, a targeted NGS method, showed higher sensitivity for detecting rare ctDNA variants than two leading liquid biopsy assays, according to research in The Journal of Molecular Diagnostics.
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