Called the Coalition for Effective Diagnostics, the organization has called on lawmakers to pass legislation revamping diagnostics regulation, including oversight of LDTs.
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.
Study Sees Rise in UTIs Diagnosed With Molecular Panels, 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.
The firm is engaging with regulators about its recently validated Ataraxis Breast test, which it hopes to make available for clinical use next year.
The company, based outside of Grenoble in the French Alps, together with its partners has received €5 million to pursue the project.
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.
Mursla Bio, a Cambridge, UK-based company that focuses on EV isolation, biomarker discovery from EV cargo, and EV assays for clinical use, is an EVEREST participant.