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.
Biobanks have been making strides in gathering data from more diverse populations this year while the evidence for the clinical utility of embryo PRS testing remains insufficient.
Called the Coalition for Effective Diagnostics, the organization has called on lawmakers to pass legislation revamping diagnostics regulation, including oversight of LDTs.
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.
CMS Final Pricing for Genomic Procedure Codes Leaves Lab, Industry Stakeholders Wanting More
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After going through the gapfill process and releasing final pricing for six codes related to genomic sequencing procedures, the final pricing still has stakeholders worried.