Operationalizing FDA LDT Compliance: Expert Panel Reveals Essential Strategies and Actions for Meeting the 1st Reporting Milestone

AUSTIN, Texas--(BUSINESS WIRE)--Many clinical laboratories are now under the gun to achieve Phase One compliance with the Food and Drug Administration’s (FDA) LDT rule before the May 2025 deadline. Labs performing LDTs must take immediate action to protect their most important LDTs that improve patient care while generating substantial reimbursement.

This is a high stakes situation for labs offering LDTs because they have only five months to secure their most valuable LDTs. To help labs understand their best path to compliance, The Dark Report and Dark Daily are presenting the next webinar in our on-going FDA LDT series, “FDA’s LDT RULE: Steps to Prepare for Your FDA 1st Milestone Submission” on Thursday, November 7^th at 1:00 PM EST.

You and your lab team will get the insider’s essentials, centered around a comprehensive five-part plan. Part one is to conduct a thorough LDT test menu gap analysis, including assessing LDTs based on risk factors and financial value. Labs can use this roadmap to operationalize compliance by prioritizing their most valuable LDTs for the first FDA submission milestone, which involves medical device reporting (MDR) requirements, corrections and removals reporting, and complaint handling, effective May 5, 2025.

By the end of this 90-minute webinar, participants will leave with actionable insights and strategies, including:

• Developing an End-in-Mind Strategy: Craft a comprehensive approach for your menu of Laboratory Developed Tests (LDTs) to align with long-term patient care and revenue goals.
• Financial Strategy Framework: Understand current financial strategies and prepare for future exit opportunities in the LDT landscape.
• Operational Milestones: Create a detailed operational plan to successfully navigate the first FDA submission milestone involving medical device reporting.
• Categorization of LDTs: Learn effective methods to categorize LDTs into strategic groups, focusing on high-margin opportunities and export/import considerations.
• Financial Reconciliation Techniques: Develop skills in reconciling your financial plan by conducting comprehensive risk assessments and gap analyses.

You’ll hear these three recognized experts speak to specific elements of this five-part LDT compliance plan, including:

Valerie Palmieri CEO of MOMENTUM Consulting. Building from her track record in scaling high-growth biotech companies with LDTs and bringing them to market successfully and profitably, she will address the importance of prioritizing each LDT offered by a lab by an assessment of topline revenue the LDT generates; the net profit it produces; and the clinical impact it delivers to physicians, patients, and payers.

Dr. Kim Dickinson a Senior Pathology Leader at MOMENTUM Consulting. With her background in global clinical trials and diagnostic testing, she will address the differences in FDA oversight of medical devices compared to CLIA oversight of clinical laboratory testing. She will share processes to drive continuous process improvement and ensure compliance with FDA and related regulations.

Dr. Marilyn Owens is a Senior Consultant at MOMENTUM Consulting and has deep experience in managing clinical and surgical pathology laboratories. Her guidance on the elements of the webinar’s Five-Part LDT Compliance plan will be particularly relevant to labs offering LDTs in anatomic and hematopathology, immunology, infectious disease, molecular oncology, and genetics.

Full details on the speakers, webinar content and how to register for this valuable webinar are at https://www.darkdaily.com.

For additional information, contact Amanda Curtis, 512-264-7103.

About The Dark Report

Established in 1995, The Dark Report is the leading source of exclusive business intelligence for medical laboratory CEOs, COOs, CFOs, pathologists and senior industry executives. It is widely read by leaders in laboratory medicine and diagnostics. The Dark Report produces the famous Executive War College on Laboratory and Pathology Management every spring.