Bradley Merrill Thompson Quoted in “Lab Directors Look for Ways to Adjust to Proposed LDT Framework”

The Gray Sheet

Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Pharma & MedTech Business Intelligence’s The Gray Sheet, in “Lab Directors Look for Ways to Adjust to Proposed LDT Framework,” by Sue Darcey. (Read the full version — subscription required.)

Following is an excerpt:

“I agree that the CLIA procedures for certain populations are generally not sufficient,” Bradley Merrill Thompson, attorney with Epstein, Becker and Green, told “The Gray Sheet.” Thompson, who represented the Combination Products Coalition, sat on the workshop panel with Gutman and Putcha addressing “components of a test and LDT labeling considerations.”

“For example, for a test marketed with information about the value that a new biomarker offers in diagnosing disease (which is not an uncommon practice), CLIA will probably be insufficient, because it doesn’t address clinical validity,” said Thompson. At the same time, he said, “I think some CLIA requirements might get you reasonably good information on the analytical performance of a test.”