The discussion draft includes the regulatory proposals, including precertification, the FDA provided to legislators in a technical assistance document.
At the Personalized Medicine Conference this week, stakeholders historically at odds over lab test regulation said it is up to Congress to resolve the issue.
The agency's regulatory plan differs in key areas from a draft of the Diagnostic Accuracy and Innovation Act that had shored up lab industry support.
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MHRA has also published a draft guidance for institutions that offer such tests so that they can gain compliance with the new directive.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.