AMP and the LDT Lawsuit

We recently spoke about The Association for Molecular Pathology (AMP)’s lawsuit against the FDA for its final rule regulating laboratory developed tests (LDTs). Now, we connect with AMP CEO, Laurie Menser, ahead of the AMP 2024 annual meeting and expo to discuss the implications and goals of the lawsuit.

What was the catalyst for AMP to file this lawsuit – what challenges does the FDA’s rule bring to the pathology field?
 

AMP is very concerned about the wide-sweeping and long-lasting consequences the FDA rule will have for our members and patients across the country. The FDA rule threatens the ability of professionals in clinical laboratories, including many academic medical centers, reference laboratories, and community health systems across the country, to create, adapt, and modify LDTs to meet patients’ needs, account for supply chain issues, reflect advances in scientific understanding and practice standards, and improve performance characteristics.

AMP is committed to protecting the interests of our members and the patients we serve. We filed this lawsuit to ask the Court to overturn the FDA rule given the agency’s lack of statutory authority to regulate LDTs and to avert the significant and harmful disruption to laboratory medicine. This action was taken after months of careful consideration of the potential consequences of this drastic policy change on patient care and the practice of molecular pathology.

What are the potential implications for patient care if the rule is enforced as proposed?
 

For decades, LDTs have led to significant clinical advancements and breakthroughs in rare and infectious diseases, human genetics, oncology biomarker testing, and more. Often created in response to unmet clinical needs, they are instrumental for early and precise diagnosis, disease monitoring, and treatment guidance. It’s important to note that Congress has not given the FDA the authority to regulate LDTs as manufactured products, but, instead, authority was delegated to CLIA at the Centers for Medicare & Medicaid Services (CMS) to regulate these procedures as laboratory services under the Public Health Service Act.

Many laboratory professionals will have no choice but to stop providing patients with cutting-edge medical care and abandon ongoing efforts to develop new LDTs that could timely diagnose fast-moving diseases and mitigate emerging public health threats. Others will risk bankruptcy and closure of their laboratories in response to the cost of complying with FDA’s new mandates – leading to significant job losses in the pathology profession, driving future doctors into other fields, reducing training opportunities, and further exacerbating the ongoing shortage of pathologists in the US.

Many smaller laboratories aiming to survive the FDA’s regulatory overreach – especially those serving isolated, rural, or disadvantaged communities – will not have the financial security to continue to practice and will be faced with challenging decisions to close their operations and/or consider consolidation with the few national laboratory conglomerates or private equity firms that can afford the extraordinary cost of FDA compliance.

As a result, competition and innovation among labs will be significantly reduced. And patients will ultimately pay the price. Not only because labs will likely raise prices to cover the Final Rule’s high compliance costs, but also due to delays or limited access to tests that could have helped prevent, diagnose, or treat conditions sooner if new LDTs were available. It is imperative that this Court acts to prevent these catastrophic consequences.

How does the FDA’s final rule affect innovation in LDTs within the field of molecular pathology? Are there specific types of tests or procedures that you believe are most at risk under this regulation?
 

The final rule impacts all laboratory developed testing procedures, regardless of the type, putting the entire field of molecular pathology at risk. The FDA gave itself the power to regulate any LDT on the market and expressly reserved the right to take enforcement action against any LDT at any time – including LDTs that were created and in use prior to May 6, 2024.

As stated above, competition among laboratories, and the innovation it spurs, will be greatly hampered by the FDA rule. AMP will continue to advocate for a more effective and efficient legislative framework that supports innovation while ensuring high-quality patient care. Our proposal to modernize the current CLIA regulations is a key part of this effort, and we believe it offers a better path forward than the FDA’s final rule.

What is the ultimate goal of the lawsuit from AMP’s perspective?
 

Our lawsuit asks the Court to completely overturn the FDA rule and prevent the FDA from enforcing it, as the agency lacks the legal authority to regulate LDTs and the need to avert the significant and harmful disruption to laboratory medicine. We are very confident in our position and hope to receive relief from the Court as soon as possible.

How do you anticipate this lawsuit will affect the broader landscape of diagnostics and precision medicine? Could this ruling have implications for other areas of laboratory medicine or the development of emerging technologies?
 

AMP is concerned that the majority of labs across the nation will not be able to afford the exorbitant compliance fees imposed by the final rule. As a result, a massive consolidation of laboratories will most certainly stifle innovation, reduce training opportunities for the next generation of laboratorians, and increase costs to the healthcare system. The consolidation of labs could also result in testing monopolies, which was previously seen in precision medicine prior to 2013, when genetic sequences were patent-eligible and patients often could not access or afford testing.

However, once genetic sequences were no longer patent-eligible due to the AMP versus Myriad Supreme Court ruling, laboratories immediately began offering other testing options, the field flourished, and the cumulative market capitalization for the precision medicine industry nearly quadrupled to $132 billion in 2022. If AMP successfully overturns the rule, the incredible advances we have seen in this field over the last few decades will continue.

Given the FDA’s stance on LDT regulation, do you think we are moving toward increased federal oversight in molecular pathology and laboratory medicine as a whole? How might this trend impact the profession over the next five to ten years?
 

LDTs are essential medical procedures that are designed, developed, validated, performed, and interpreted by highly trained medical and scientific experts in highly regulated clinical laboratories. LDTs are protocols and differ vastly from medical devices; they aren’t manufactured, packaged, or commercially distributed as medical devices.

LDTs are already highly regulated through the existing CMS CLIA program. This program has successfully run for nearly 40 years and has led to hundreds of thousands of safe and effective tests on the market.

AMP has long maintained that the best way to ensure the development of accurate and reliable LDTs is by modernizing current CLIA regulations. AMP's legislative proposal to update CLIA builds on the existing oversight framework and provides enhancements to ensure test quality.

What advice would you offer to pathologists and laboratory professionals who are concerned about the impact of the FDA’s rule on their work? How can they stay informed and involved as the lawsuit progresses?
 

If you or your organization is interested in supporting AMP in this lawsuit, there are a few ways to do so. Firstly, join AMP and help shape the future of the molecular diagnostics field. You can also educate yourself on the issue at hand, reading up on AMP’s position on the regulation of LTDs.

After conducting your own research, you can get involved serving on one of our volunteer committees, working groups, or task forces to provide your views and assistance to the cause directly. It’s also important to engage with your local community and educate individuals on what this ruling could mean for your practice and patient care. AMP is currently surveying the community on the impact of the FDA rule – feel free to add your thoughts!