GOP Wants Check-In On FDA’s Lab Safety Issues

Berlin medtech associations add to European voice requesting that the EU eases MDR/IVDR and other compliance costs on SMEs.

A recent conference panel discussed the stagnation in diagnostics regulation, highlighting the FDA's failed regulatory efforts on lab-developed tests. Political and legislative challenges hinder other reforms, and concerns over Medicare reimbursement cuts loom for the clinical lab industry.

Quest is actively building collaborations with academic and pharmaceutical partners to integrate Haystack MRD into clinical investigations. These partnerships are not yet public but span multiple tumor types and therapeutic areas, VP Dan Edelstein said.

The agency is creating two new AI councils to facilitate its role in responsible AI adoption and regulation.