International Consensus Statement Says Microbiome-Based Diagnostic Tests Not Ready for Prime Time
Researchers laid out a set of ethical, organizational, and technical guidelines for the development, commercial use, and clinical implementation of microbiome tests.
Molecular Panel Use for UTI Diagnosis Increasing Despite Lack of Clinical Evidence for Tests
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Using claims data, researchers saw an uptick in urinary tract infections diagnosed with pricey molecular panels, notwithstanding their limited clinical evidence.
Becton Dickinson's HPV assay was FDA-approved for use with clinician-collected samples in 2018 and received approval for sample self-collection in May.
The McGill University team is advancing a test, dubbed DOvEEgene, which sequences DNA from a uterine brush sample to detect cancer-associated mutations.
The firm is engaging with regulators about its recently validated Ataraxis Breast test, which it hopes to make available for clinical use next year.