FDA Pathway Options Are Growing For Diagnostics, FDA's Gottlieb Tells Commercial Labs
While lab-developed test (LDTs) remain under a US FDA enforcement discretion policy, the agency is working on several fronts to offer appealing regulatory pathways for advanced diagnostic services, FDA Commissioner Scott Gottlieb told American Clinical Laboratory Association members.
You may also be interested in...
House Panel Approves Boosts For FDA Digital Health Plan, Quality Medtech Manufacturing
The US House Appropriations Committee in 2019 wants to give FDA an additional $40m to boost its digital health oversight, $12m more to “create a competitive marketplace for device quality,” and instructs the agency to keep working with Congress on a new laboratory-developed test regulatory path.
Labs, Test Makers Urge Congress To Pass Diagnostic Reforms
More than 80 industry, laboratory, health-care provider and patient groups sent a letter to two congressional committees, urging them to advance a bill to modernize the current way FDA regulates diagnostic tests, including possibly a new regulated product category that combines laboratory developed tests and in vitro diagnostics.
Abbott Strikes Deal With British Liquid Biopsy Company Angle
Abbott and UK-based Angle plc announced they will collaborate on a breast cancer liquid biopsy study, assessing Angle's technology for harvesting circulating tumor cells in combination with Abbott's FDA-approved gene-based test for determining HER-2 status.