LDT Final Rule: This session will have you covered

April 11, 2024

by Bob Croce

For The Executive War College

We’re on the edge of our seats, waiting for the Food and Drug Administration (FDA) to make official the final rule on Lab Developed Tests (LDTs), and wouldn’t it be interesting if it all came down during the 29^th Executive War College.

Suddenly, “Oversight of LDTs: How Labs Will Need to Comply, Steps to Take Now, and Analyzing the Financial Impact of Compliance” becomes an even more must-attend session.

Jane Pine Wood, Sheila Walcoff, and Valerie Palmieri will lead this session, which once again shows how EWC brings you the latest and greatest info on what’s happening right now. It’s like being in the right place at the right time; like observing “totality” on Monday somewhere in America.

It’s actually one of several sessions we have on the LDT final rule. Check out our agenda for all the details.

Wood, from McDonald Hopkins (pictured above), has over 30 years of representing clinical laboratories and anatomic pathology groups, hospitals, health systems and more.

Walcoff is a nationally recognized FDA policy expert, who currently advises precision medicine companies and boasts an impressive 25-plus years of experience.

Palmieri is executive chair on the Board of Aspira Women’s Health and previously served six years as the national Vice President of anatomic pathology operations at LabCorp.

The goal of the session will be to give you what you need to start complying with the LDT final rule soon as you get back to your labs.

Topics of the session will include the following:

The elements of a ‘LDT play book’ for complying with the anticipated FDA requirements.
A framework for analyzing whether certain LDTs will be worth retaining.
An understanding of the resources that may be needed to meet future compliance.

That’s it for this week. More dispatches to come. Hope to see you and your “krewe” in New Orleans.

(Bob Croce is Executive Publisher/General Manager of The Dark Intelligence Group, the company that brings you the Executive War College. Have a question or comment for Bob, you can reach him at bcroce@darkreport.com)