Lab Group Urges FDA To Wait For Congress On LDT Issue
This article was originally published in The Gray Sheet
Executive Summary
Jeff Shuren recently spoke at the annual American Clinical Laboratory Association industry meeting where the device center director was grilled on FDA's plans to regulate lab-developed tests. While ACLA President Alan Mertz appreciates Shuren's willingness to engage, his group continues to push back hard against the agency's plan to move forward with a final LDT plan before Congress has a chance to act.
You may also be interested in...
FDA Puts Lab-Developed Test Oversight Plans On Hold
After years of wrangling over lab-developed test regulations with laboratory lobbyists, FDA has put its plans to finalize a guidance that lays out its oversight framework for LDTs on hold as a new Congress and a new deregulation-focused president-elect is set to take the helm.
US Policy-Makers Prioritize Liquid Biopsies
Liquid biopsies have been a priority topic for policy development by US FDA and the broader Obama administration. During the past year, FDA has kicked itself into high gear to provide test-makers with more insight into its thinking and, this summer, the agency approved the first liquid biopsy test.
Guardant Looking Ahead To Insurers, FDA On Liquid Biopsy
Guardant Health recently announced that the first US health insurance plan covered its Guardant360 liquid biopsy system. CEO Helmy Eltoukhy spoke to Medtech Insight about the milestone and the firm's plans to gain FDA approval as the agency moves to oversee laboratory-developed tests. Read the story and listen to the podcast interview.