FDA Clears Roche’s Cobas c 703 and ISE Neo Analytical Units
The FDA has cleared Roche’s cobas c 703 and cobas ISE neo, high-throughput analytical units designed to automate workflows and address staffing and capacity challenges.
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Search Results for: liver disease
FDA-Approved PD-L1 Companion Diagnostic Expanded to Esophageal and GEJ Carcinoma
The companion diagnostic can now help identify patients with esophageal or gastroesophageal junction carcinoma who may be eligible for pembrolizumab treatment.
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FDA Grants CLIA Waiver for Rapid Test That Differentiates Bacterial and Non-Bacterial Respiratory Infections
The FDA has granted a CLIA waiver for FebriDx, enabling its use in over 300,000 U.S. point-of-care settings and potentially reaching 80 million patients annually, according to PHASE Scientific.
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Large Study Shows Genetic Risk Results Can Be Returned to Thousands of Patients—With Caveats
A national eMERGE study found that genetic risk results can be returned at scale, with over 70% of high-risk patients receiving counseling, though disparities in access persist, according to the American Journal of Human Genetics.
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CSF Liquid Biopsy Delivers 82% Clinical Impact Rate in CNS Lymphoma Cases
A retrospective study in Lymphatics reports that CSF liquid biopsy testing delivered clinical impact in 82% of CNS lymphoma cases, resolving diagnoses and informing treatment when standard methods were inconclusive.
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