Pathology News Roundup: September 4, 2024

Battle Over FDA's LDT Rule Continues. The Association for Molecular Pathology (AMP) has filed a lawsuit against the FDA, challenging the Final Rule on regulation for Laboratory Developed Testing (LDT) procedures. 

AMP is the second group to file suit against the FDA regarding this issue, following the American Clinical Laboratory Association (ACLA), which had already initiated a lawsuit over the new LDT rule back in May.

The final rule, which had been years in the making, sets a series of deadlines starting in 2025 for review of LDTs by the FDA. Many labs and industry groups oppose the rule, saying that the drastic policy change will stifle diagnostic innovation, impose billions of unnecessary dollars in healthcare mandates, and threaten patient access to essential medical procedures.

"AMP remains very concerned about the wide-sweeping and long-lasting consequences the FDA rule will have for our members and patients across the country," said Maria Arcila, MD, President of AMP. "We filed this lawsuit to ask the Court to vacate the FDA rule given the agency’s lack of authority to regulate LDTs and to avert the significant and harmful disruption to laboratory medicine. AMP will continue working with key stakeholders to develop a more effective and efficient legislative framework that ensures high-quality patient care while continuing to foster rapid innovation and the promise of new diagnostic technologies."

The College of American Pathologists has also spoken out against the new final rule for LDTs, saying, "The CAP is greatly concerned that the FDA is moving forward with its regulatory oversight plan for LDTs without making the additional changes needed to ensure both patient safety and access to accurate and innovative testing."

Laboratories and pathologists—many having never worked with the FDA—now have more questions than answers as they face implementation of the LDT regulation’s first phase in 2025.

While the CAP opposes the regulation and is actively working to stop the FDA, the organization is committed to helping the pathology and laboratory community understand and prepare their operations. To that end, the CAP is holding a six-part webinar series starting Sept. 18 on the new LDT oversight rules.

AAPA's Annual Conference is Coming! Less than two weeks to go until the American Association of Pathologists' Assistants' big annual conference... but there is still time to register. AAPA's 49th Annual Conference: "Hot Topics in Pathology" kicks off on Sunday, September 15 and runs until Thursday, September 19, at the Westin Fort Lauderdale Beach Resort in Fort Lauderdale, FL. 

This is a hybrid event... so you can choose to attend in person or virtually! Enjoy a variety of speakers and educational events, along with invaluable opportunities to network with PA peers!

The AAPA is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS PACE^TM Program. The maximum number of credits available at the AAPA 49th Annual Conference will be 23 (or 26 with the workshop add-on). To be eligible to receive continuing education credit, you must have passed the ASCP BOC exam prior to this conference AND you must have your name badge scanned upon entering EACH lecture. You must be scanned within the first 10 minutes of the start of the lecture or workshop to receive credit. Scanning is also required at each poster session along with your completed quiz submission.

Register online!