Joint Commission Launches System Survey Option for Laboratory Accreditation
The new concurrent survey model aims to reduce administrative burden and promote operational consistency across healthcare systems.
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FDA Clears Roche PCR Test for Bacterial Vaginosis and Yeast Infections
The FDA has cleared Roche’s cobas BV/CV assay, a molecular test that detects bacterial vaginosis and Candida vaginitis from a single swab, enabling streamlined diagnosis on the cobas platform, according to Roche.
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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
Ibex Earns European Certification for Complete Breast Pathology AI Suite
Ibex Medical Analytics has received IVDR certification for its breast cancer diagnostic tools, completing regulatory approval for ER, PR, and Ki67 tests, according to a company press release.
Equipment & Supply Spotlight
Roche Receives CE Mark for Tuberculosis Blood Test
The automated assay identifies latent infections in routine laboratory settings with results available in less than 24 hours.
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Disease Detection & Understanding
Researchers Link Gene Variant to Aggressive Prostate Cancer Risk
Researchers report that inherited CDK12 gene variants may increase risk for early, aggressive prostate cancer, suggesting inclusion of CDK12 in hereditary screening panels could improve risk identification in men.
