AUSTIN, Texas– With the first important deadline for compliance with the Food and Drug Administration’s (FDA) LDT rule only eight months away, experts urge clinical laboratories performing LDTs to take immediate action. This is essential to protect their most important LDTs that improve patient care while generating substantial reimbursement.
The FDA’s final rule on Laboratory Developed Tests (LDTs) ushers in a radical overhaul of the FDA’s longstanding policy of enforcement discretion involving LDTs. Labs that fail to comply with the new federal rule by May 2025 will no longer be able to offer these key diagnostic tools, impacting patient access to care and cutting the lab’s ability to be paid for LDT claims.
Clinical laboratories and genetic testing companies face unprecedented challenges with this ruling and must take immediate steps to understand the LDT rule and develop a compliance plan with timeline. To help clinical labs understand the specific steps they must take to bring existing LDTs into compliance with the new rule, The Dark Report and Dark Daily are presenting a timely webinar, “FDA’s LDT RULE: Understanding What’s Compulsory, What’s Not!” on Thursday, September 12 at 1:00 PM EDT.
First speaker is Jane Pine Wood, Counsel in McDonald Hopkins’ national Healthcare Practice Group. Wood will speak to the specifics of the FDA LDT rule, detailing what’s clear; what’s not; where more agency guidance is needed; and the ‘must do’ steps needed for labs to keep their LDTs compliant. Wood will also speak to the academic medical center and hospital exemption and legal issues triggered by this section of the FDA rule.
Second to speak is Valerie Palmieri, CEO of MOMENTUM Consulting. Palmieri’s proven track record in scaling and transforming high-growth biotech companies includes developing LDTs and bringing them to market successfully and profitably. She will address the importance of prioritizing each LDT offered by a lab by assessing the topline revenue it generates; the net profit it produces; and the clinical impact it delivers to physicians, patients, and payers.
Next to present is Sheila Walcoff, CEO and Founder of Goldbug Strategies. Walcoff has unique experience from working inside the FDA, Congress, and other federal agencies. She provides strategic regulatory and policy advice and counsel on the breadth of issues related to medical product reimbursement policies; legislative strategy; and advocacy for medical products. She will explain why labs need to act immediately to comply with the multiple elements in the final LDT rule and provide a roadmap that labs can use to define their LDT compliance strategy.
