Seventeen organizations don't support the Diagnostic Accuracy and Innovation Act as written and would like lawmakers to advance a CLIA-centric framework.
Clinicians are using Roche's Cobas Omni Utility Channel to run lab-developed PCR tests alongside in vitro diagnostic kits, freeing valuable resources for labs.
MHRA has also published a draft guidance for institutions that offer such tests so that they can gain compliance with the new directive.
The similar analytic performance of LDTs and FDA-approved tests informs the ongoing debate about the regulation of in vitro testing.
The company is developing an epilepsy test based on inflammatory proteins in patient blood that is intended for ruling out patients with seizure-like symptoms.
The company discussed expectations for how its products will fare against rivals into next year based on recent data and coverage decisions, and on expected reimbursement changes.
Participants shared data from head-to-head assay comparisons, reflected on the advancement of NGS and digital PCR methods, and discussed new standardization projects.
Their study suggests that commercial IHC assays for PD-L1 can yield compatible and transferrable results if handled appropriately.
Geneticists and periodontists point to financial conflicts, the lack of genetics knowhow, and regulatory gaps for the availability of a test they say should have never come to market.
Entering a new chapter with a new leader, ACLA lends support to a draft bill that would regulate lab tests not as medical devices but as in vitro clinical tests.