CHAMPion

Spring 2024

Dear AMP Members,

As I finish my first month as AMP’s new Chief Executive Officer, I was asked to take a minute to reflect on what AMP’s policy and advocacy work means to our members and the patients you serve. Four years ago, I decided that if the opportunity to serve as AMP’s lead administrator ever became available, I wanted to apply for consideration. At that point, I had worked at AMP in some capacity for over 13 years, but the decision came when my Mom was diagnosed with non-small cell lung cancer (NSCLC).

A cancer diagnosis is devastating for patients and their families. We immediately had to learn a new vocabulary and map out a complicated treatment plan. I knew from my work at AMP that it was critical that she received timely and appropriate molecular testing. I had spent much of the last 13 years talking to stakeholders about the barriers to best patient care in cancer. Navigating this labyrinth with my Mom as the patient was a completely different experience.

I saw firsthand what those barriers are and what they mean for patients trying to access molecular testing, not just in cancer, but across the board. It gave me a whole new perspective on the incredible work that AMP members do. You save lives every day; by fighting for better access, closing gaps in coverage and reimbursement, educating on, and advocating for practice improvement, and bringing cutting-edge discoveries to patients who need them. Seeing your work, through the lens of a patient, made me even more dedicated to serving AMP and its members. I am honored to take this opportunity to serve AMP. And…I’m delighted to tell you that Mom was the first person I called when I heard I got the job. She’s recovered and is doing great!

I’m eager to partner with you to fight for your profession and for the patients you serve. I look forward to seeing all that we will accomplish together.

Sincerely,

Laurie Menser, CAE

Chief Executive Officer, AMP

FDA Proposed Rule seeks to regulate LDPs as medical devices

On October 3^rd, 2023, the U.S. Food and Drug Administration published a proposed rule that seeks to regulate all laboratory developed testing procedures (LDPs) as medical devices. AMP released a statement later that day in opposition to the proposed rule, noting FDA had overstepped its authority by attempting to implement this regulation. The open comment period for the FDA proposed rule closed on December 4^th, 2023. There were a total of 6,707 comment submissions, including AMP’s extensive comments and many other prominent stakeholders. Thank you to all members who submitted individual comments to the docket!

AMP continues to engage and advocate for patients and members as the Rulemaking process progresses. AMP is actively engaging with Congressional offices to voice opposition to the rule and to provide AMP’s 2023 CLIA modernization proposal as the most cost-effective, streamlined approach to LDP regulation. The proposal is an alternative legislative pathway that gives much needed clarity to the current statute and includes a section specifically dedicated to Laboratory Developed testing Procedures as well. For more on the CLIA Modernization Proposal, please see below.

AMP will keep you updated on advocacy efforts and federal developments as this process continues, including opportunities to engage further on this issue.

AMP 2023 CLIA Modernization Proposal

AMP maintains the position that Laboratory Developed Testing Procedures (LDPs) should remain under the authority of the Centers for Medicare and Medicaid Services (CMS), Clinical Laboratory Improvement Amendments (CLIA) of 1988. This oversight will preserve a flexible system that fosters innovation and is the most streamlined, cost-effective approach that addresses clinical and analytic validity, expands proficiency testing requirements and enhances transparency.

In 2023, AMP created the Regulatory Reform Task Force to update the CLIA Modernization Proposal that was last drafted in 2018. The Task Force incorporated broad stakeholder input and finalized the proposal in November 2023. The proposal encompasses the highest standards of practice in the field of Molecular Pathology and would definitively remove FDA oversight of LDPs. The proposal expands current CLIA regulations to reflect the modern field of laboratory medicine and enhances transparency to ensure high quality testing is achieved without the need for a premarket review process. AMP continues to work with stakeholders and Congressional offices to move this initiative forward. The proposal was drafted into legislative text and AMP met with several congressional offices to identify potential sponsors to introduce the proposal to Congress. Thus far, AMP participated in a total of 22 meetings with key members of Congress and will update the membership on the progress of this proposal. For more information, please see the links below!

CLIA Modernization Proposal

Frequently Asked Questions

Section by Section Breakdown

AMP releases "The Impacts of the European Union In Vitro Diagnostic Regulation (IVDR)" Survey Report

In April 2023, AMP circulated an international survey to molecular professionals to investigate the impacts of the recent European Union (EU) In Vitro Diagnostic Regulations (IVDR) would have globally on clinical laboratories and patient access to care. We would like to thank all of those who participated in the survey process. AMP previously announced a survey report would be forthcoming (Spring 2023 ChAMPion).

AMP is glad to announce the release of the survey report entitled The Impacts of the European Union In Vitro Diagnostic Regulation Survey Report. This data will be used to inform future advocacy, as AMP plans to conduct follow-up surveys, one in 2026 and another in 2030 to track laboratory progression throughout the IVDR process. This project was generously supported by Loxo@Lilly.

Patent Eligibility Restoration Act (PERA) seeks to patent genes, overturn AMP v. Myriad

Throughout 2023, AMP strongly advocated against S. 4734, the Patent Eligibility Restoration Act (PERA) of 2023, which would allow genes, isolated DNA and its association to health conditions, laws of nature and abstract ideas to be patented. PERA was introduced by Senators Chris Coons (D-DE) and Tom Tillis (R-NC) and would revise Section 101 of the Patent Act, which defines what inventions are eligible for patenting. PERA would not only overturn the AMP v. Myriad Supreme Court decision, it would also abrogate 150 years of case law, by reforming Section 101 of the patent law to include genes, laws of nature, and abstract ideas to become patent eligible. For more details on actions taken in 2023 please see our Fall 2023 ChAMPion.

AMP continues to fight against PERA in the new year. Senator Bill Cassidy (R-LA), released a Request For Information (RFI) on Improving Americans’ Access to Gene Therapies. AMP submitted a response on January 19^th and is grateful for these efforts that seek to recognize the technological and medical advances that have been made to develop successful interventions and therapies for patients with ultra-rare disorders, along with the research and development of emerging innovative therapeutic approaches.

On January 23^rd, the Senate Judiciary, Intellectual Property Subcommittee held a hearing to discuss PERA. AMP submitted written testimony for the record of the hearing, reaffirming the position that genes should not be patentable. Both the RFI and Testimony can be found linked below.

This issue remains a top priority for AMP advocacy and as discussions move forward, AMP will continue to advocate against this legislation and keep the membership informed on opportunities to get involved.

AMP’s First Patient Outreach Video: Inside a Molecular Lab

AMP is excited to announce the release of the first animated, educational video series on the AMP advocacy patient-facing website. This series aims to provide patient education in a format easily accessible for the general public. The video, entitled, "Inside a Molecular Laboratory", gives the audience an introduction to molecular pathology and an “inside look” at a Molecular Diagnostic Laboratory. Additionally, this video is currently being translated into Spanish, so stay tuned!

Check out this video, other resources, and more on our Patient Advocacy at https://outreach.amp.org/.