CHAMPion

Fall 2021

Meet the Chair of the PRC Patient Engagement Subcommittee!

Jill Murrell, PhD, is a Director within the Division of Genomic Diagnostics at the Children's Hospital of Philadelphia and Associate Professor of Pathology and Laboratory Medicine at the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA. In addition to being an AMP member, Dr. Murrell has been a member of the Professional Relations Committee (PRC) since 2017 and became Chair of the PRC Patient Engagement Subcommittee in 2021.

Image: Dr. Murrell (third from left) participates in the 2019 AMP Advocacy Day along with Drs. Annette Kim, Jason Rosenbaum, and Lloyd Hutchinson (left to right).

How did you get involved in the PRC Patient Engagement Subcommittee at AMP?

I saw the call for volunteers for the Professional Relations Committee (PRC) and read the aims of the committee. I submitted my application because I was especially interested in the committee’s goal to increase efforts to engage with patients, patient advocates and groups. When I joined the committee, naturally, I volunteered for this subcommittee. I ran a research lab for 20 years and the best part of that work was meeting the families we were trying to help. They provided the spark and inspiration to keeps us going. Now that I work in a clinical lab, we are always cognizant of the patient/family behind that clinical laboratory report. Though we may never meet our patients, they are foremost in our efforts to provide the most accurate, efficient and cost-effective testing available.

How has the subcommittee engaged with patients? Which activity/project did you enjoy the most?

The subcommittee has provided informational sessions in the form of Lunch and Learns. These have been held in person in the past and at our national meetings. Currently, these have been done virtually. Recent topics have addressed laboratory testing in the realm of COVID. We discussed our survey findings about how the pandemic affected molecular diagnostic testing and learned how the pandemic was impacting their patients. These are fun and informative because we learn from each other.

Another major project to engage patients and advocates is the AMP Molecular Medicine for Patients website. Here we have developed a cool graphic that displays what goes on in a clinical molecular diagnostic laboratory. Also, there are sections that go in detail about cancer genetics and testing. We are currently developing a question/answer section with awesome graphics for COVID-19 testing. A few of our patient advocates are beta testing it now.

You are now the Chair of the Subcommittee, what do you hope to see from the Subcommittee in the next few years?

In the near term, I hope to see a fully populated Patient-facing website. We are making great progress and have completed the cancer module and are almost finished with the COVID-19 Q&A section. Next, the subcommittee plans to tackle the Inherited Conditions section. Our virtual Lunch and Learns have been very well attended and we plan to continue those until we are able to host in person events again.

Looking forward, I would like to see more personal interaction with patients. The pandemic has made this difficult and I can’t wait to be able to expand on our in-person events and give patients an idea of what we do and why we do it!

Do you have any advice for AMP members who would like to engage more closely with the patient community?

Come join our subcommittee! We would love to have you. We are always looking for volunteers and new ideas. Also, there are plenty of patient advocate groups who are looking for clinicians, laboratory professionals, experts to speak to and/or help educate their patient population, provide guidance (medical advisory councils), fundraising opportunities, help review grants, etc. All you have to do is reach out to policy@amp.org and let the learning begin.

AMP Continues to be a Leader in the COVID-19 Pandemic Response

As laboratories continue to respond to the COVID-19 pandemic throughout 2021, AMP has been engaged in a number of clinical, educational and advocacy campaigns in order to help support our members:

AMP as a Trusted Resource for COVID-19 Information

Since February 2021, the AMP COVID Response Steering Committee Blog has kept the AMP membership and general public informed on key issues impacting molecular professionals on the front lines of the COVID-19 pandemic. Additionally, the AMP “Testing Resources for COVID-19” webpage continues to be updated with new resources enabling members to stay up to date on the most recent advances in COVID-19 diagnostic testing, including changes to regulatory policy and clinical practice announcements.

AMP Remains Engaged with Patient Advocacy Community

In 2020, the AMP Patient Engagement Subcommittee (part of the AMP Professional Relations Committee) shifted the Lunch and Learn patient advocacy event series to an online, virtual format. Through these events, AMP members had in depth conversations with the patient advocacy community regarding COVID-19, diagnostic testing, and the impact of the pandemic on diagnostic testing for cancer and inherited conditions.

The most recent Lunch and Learn event took place on August 30^th and focused on the role of testing in the current phase of the pandemic, how sample sequencing has led to the detection and monitoring of COVID-19 variants, and the impact of rising case counts on testing supplies and non-COVID-19 testing, among many other topics. The Lunch and Learn events have been incredibly well received by the patient advocacy community, and we thank the AMP members who have volunteered their time to participate!

Beyond the COVID-19-focused Lunch and Learns, AMP has continued to provide educational resources to the patient community and general public through the AMP Outreach Webpage. Based on requests from the patient advocacy community, AMP is working to launch the first iteration of the infectious disease portion of the website that will focus on molecular diagnostic testing for COVID-19 in September. We invite the AMP membership to keep an eye on their email for the launch of this new resource and to share it freely! As always, please contact us with any suggestions you may have for this patient-facing website at policy@amp.org. The Patient Engagement Subcommittee thanks the Infectious Disease Subdivision Leadership and the COVID-19 experts within our community for their valuable input and expertise!

AMP Advocates for COVID-19 Vaccine Requirements for Healthcare Workers

In August, AMP signed on to a Cancer Leadership Coalition letter advocating that all health care employers require their workers to receive the COVID-19 vaccine and that all health care professionals accept vaccination without delay. The letter was supported by twelve other cancer patient, health care professional, and research organizations.

AMP Advocates for Appropriate Oversight of Laboratory Developed Testing Procedures (LDPs)

This Spring, AMP was proud to support the reintroduction of the Verified Innovative Testing in American Laboratories (VITAL) Act of 2021! The VITAL Act was introduced by Senator Rand Paul (R-KY) on May 18, 2021. The VITAL Act includes the following four major provisions:

Codifies that regulation of laboratory developed testing procedures (LDPs) rests within CLIA and not the FDA, including during a public health emergency,
Defines LDPs as a professional medical service,
Mandates CMS hold a public meeting no later than 90 days after the enactment of this Act to solicit recommendations on ways to modernize the CLIA regulations, and
Directs the HHS Secretary to report to the Senate Health, Education, Labor, and Pensions Committee and the House Energy and Commerce Committee on recommendations for modernizing CLIA as well as provide an assessment of the availability and utilization of LDPs during COVID-19 pandemic response.

The VITAL Act of 2021 is nearly identical to the version that was introduced in 2020, and is a direct result of AMP’s continued advocacy on this issue. Since its reintroduction, AMP members have sent over 50 letters of support for the VITAL Act and AMP has met with 22 offices on the Hill to discuss support for the legislation. Recently, AMP championed a sign-on letter in support of the legislation along with the American Association for Clinical Chemistry (AACC), the Association of Pathology Chairs (APC), and the American College of Medical Genetics and Genomics (ACMG). The letter was sent to Congressional offices with an interest in this issue on September 8, 2021, with the support of 30 groups representing academic institutions and departments, hospitals, and health systems across the country. If you are interested in engaging in discussions on this topic with your institution, AMP is happy to help! We invite interested members to please reach out to policy@amp.org.

Discussion on Capitol Hill is sure to continue as Representatives Larry Bucshon M.D. (R-IN) and Diana DeGette (D-CO) along with Senators Richard Burr (R-NC) and Michael Bennet (D-CO) reintroduced the Verifying Accurate Leading-Edge IVCT Development (VALID) Act at the end of June. The VALID Act creates a single regulatory pathway at the FDA for both LDPs and in vitro diagnostic tests (IVDs), and AMP has communicated our concern with this proposal to the bill sponsors multiple times, most recently in a letter on October 19, 2020. You can read about the history of AMP’s advocacy work surrounding the VALID Act here. AMP will continue to engage with the sponsors’ offices and ensure that our members’ concerns are heard.

As the discussion of laboratory testing oversight continues to ramp up on Capitol Hill, there will be numerous opportunities for AMP members to get involved! We invite interested members to keep an eye on their inboxes for further educational and advocacy opportunities. Additionally, we invite you to visit our recently re-vamped webpage on LDP oversight, which contains up to date resources and relevant action items.

AMP's Push to Prevent Gene Patents Continues

In 2019, AMP learned about efforts from Senators Tillis (R-NC) and Coons (D-DE) and Representatives Collins (R-GA), Johnson (D-GA), and Stivers (R-OH) to revise Section 101 of the Patent Act, which defines what is and what is not patent eligible. Since that time, AMP has been heavily engaged with other stakeholders and the sponsors’ offices to express opposition to legislation that would abrogate Supreme Court precedent and expand patent-eligible subject matter to encompass “abstract ideas”, “laws of nature”, or “natural phenomena”.

The efforts by the Hill to address this issue picked back up in March of 2021 when Senators Tillis, Coons, Cotton (R-AR), and Hirono (D-HI) sent a letter to the Commissioner for Patents at the United States Patent and Trademark Office (USPTO) reasserting their belief in the need for congressional action on Section 101 and requesting that the USPTO issue a report on patent eligibility jurisprudence.

In response to the Senators’ March request, the USPTO announced a patent eligibility jurisprudence study to evaluate "how the current jurisprudence has impacted investment and innovation, particularly in critical technologies like quantum computing, artificial intelligence, precision medicine, diagnostic methods, and pharmaceutical treatments." On September 7, AMP submitted detailed comments to the USPTO, which focused on four case studies; two studies that demonstrate the historical negative impacts that gene patents had on patient care and medical innovation and two studies that reveal how innovation has been positively supported by the current patent eligibility rules. The comments highlight the growth of molecular pathology as a practice and the positive impact on the US economy, which would both have been impossible with patents on genes. AMP also plans to share our responses with relevant Hill offices and continue our strong advocacy push on this topic.

On June 8, AMP also signed onto a letter to the Biden Administration, led by the American Civil Liberties Union (ACLU), expressing concern and stating opposition to any legislative or regulatory proposals that would revisit Section 101 and overturn years of court precedent. ACLU and AMP were joined by thirty-six other civil rights, medical, scientific, technology, patient advocacy, and environmental organizations.