University Lab Directors Rebut Lawmakers' Call For OMB To Release LDT Guide

A group of 23 academic clinical laboratories, following up on lawmakers' recent press for the White House Office of Management and Budget to release FDA guidance on laboratory developed tests, sent its own letter to the White House warning that FDA regulation of the tests would have a “crippling domino effect” especially on rare disease patients. The group -- which includes lab directors from the University of Utah, Mayo Clinic, Harvard University, University of California at San Francisco, University of...