Clinical lab industry AMPed for future of molecular pathology

Jan. 23, 2020

A chilly morning in Baltimore brought molecular diagnosticians together to discuss the hot topic on all of their minds – what does the future hold for molecular pathology? The panel discussion was held on the last day of the Association for Molecular Pathology (AMP) conference in November and was clearly one of the most-anticipated sessions of the annual meeting – evidenced by the standing-room-only attendance. During the session, many lab- and healthcare-related topics were brought up for discussion; however, no others received more attention and requests for additional information than the following three topics.

Looking to the future

Session moderator Victoria Pratt, PhD, Professor, Director of Pharmacogenetics and Molecular Genetics Laboratories at Indiana University School of Medicine in Indianapolis, IN, opened the discussion by asking the four-person panel where they see molecular pathology going in the future, encouraging round-table opinions from each of the panelists.

Federico Monzon, MD, Chief Medical Officer at Castle Biosciences in Friendswood, TX, was quick to point out the field of molecular pathology is “so rapidly changing, you can’t just focus on one thing for the future. It’s diversification, it’s looking at transcending sequencing; it’s going beyond genomics. Informatics helps us with the ever-increasing complexity in molecular data, but we all need to embrace new technology and products to really take advantage of what’s available to us.”

In agreement with Monzon’s assessment, Timothy Stenzel, MD, PhD, Director of the FDA’s Office of In Vitro Diagnostics and Radiological Health in Silver Spring, MD, added, “I think our future has never been brighter than it is today, but our ability to adapt to the changes that are coming is critical. We are going to be moving more into precision medicine, which is so important now, and I believe we are going to see a lot more specialization and sub-specializations as well in the future.”

Focusing on the role of molecular pathology (MP) in the future, Gabriel Bien-Willner, MD, PhD, Medical Director of the MolDx program at Palmetto GBA in Texas, said, “The rest of medicine sees molecular pathology and molecular diagnostics as the future of medicine. With the amount of data we have, we really are at the center of the future of medicine. We are in the middle of changing paradigms on how we treat patients, and we’re going to be challenging things even more in the future, so we need to be ready for whatever changes come our way.”

Reiterating the importance of clinical data, Karen Kaul, MD, PhD, Chair of the Department of Pathology and Laboratory Medicine at Northshore and Clinical Professor of Pathology at the University of Chicago’s Pritzker School of Medicine, pointed out that “pathologists generate 75 percent of the data that determines 75 percent of the downstream action in the medical management of patients. The amount and type of data is expanding and changing dramatically with the advent of personalized medicine.” Regarding sub-specialization, she said, “Additionally, our community needs to ensure our trainees are prepared to take care of patients more precisely when they finish training, which is a challenge with this rapid evolution we are seeing.”

Affects of AI on MDx

As automation becomes a larger part of many clinical labs, the role of artificial intelligence (AI) / machine learning (ML) is expected to impact the field as well, with molecular diagnostic (MDx) demands being met by potentially faster and more accurate technology. Continuing the session discussion, Pratt focused on questions about how AI/ML could affect MDx in the future.

Panelist Dr. Stenzel reported, “Our office has been dealing with AI for a while, and we’re seeing a huge increase in people coming in to work in AI, but we’re still a long way off from being fully integrated. With AI/ML in the future, how you teach and test will be key. When we initially compared the efficiency and productivity of pathologists with AI/ML, it was always people who came out as winners, but now we’re seeing a shift with AI/ML starting to win more.”

Acknowledging existing industry apprehension about using AI, Dr. Bien-Willner asserted, “AI is a scary word to some people, but we shouldn’t be scared of it because there are a lot of AI-related ways to help pathologists do their job more efficiently. In terms of replacing pathologists at some time in the future, AI never will – because it lacks the human element, and there are certain things pathologists just do better. But when it comes to using AI, we should still embrace it, and find ways to get involved with it, which will help us keep pace with the available technologies.”

Looking at AI/ML as a necessity for clinical labs in the future, Dr. Kaul predicted, “AI, for the near future, will be tools that will help us be more accurate and more efficient. With the predicted shortage of pathologists in the future, we may need these AI tools. They could not only make us better, more effective and more efficient, but maybe more cost-effective as well.”

Next-generation pathologist success

As panelists looked ahead to the future of the clinical lab, Pratt raised the question of what could be done – in an ideal scenario – to better assist the next generation of molecular pathologists and ensure their academic and professional success, both for themselves as well as their patients.

“Our trainees need greater ability to talk to clinicians in an interactive way, in a consulting role,” asserted Dr. Kaul, adding, “They also say they haven’t learned enough about lab management, regulatory issues, etc., when they finish residency and fellowship, so our training curricula needs to include these skills, in addition to the factual and diagnostics knowledge needed.”

Also noting a disconnect between education and application, Dr. Bien-Willner said, “There is a huge gap outside of the lab with how data results are applied to the patient. Molecular pathologists deal with oncologists who often don’t know how to apply the findings we give them. They ask us what to do with the data we provide, so we tell them it’s cancer and they cut it out. Future pathologists could help oncologists more by helping them really understand the role everyone plays in patient care, and how we all have to work together for the patient.”

Voicing his agreement, Dr. Monzon added, “For a long time, we’ve only focused on providing detailed lab reports. Now, we find we’ve done ourselves a disservice by creating a barrier between the lab and the oncologists and their patients. In the future, we have to come out of the lab more to help remove this barrier.”

Summarizing a plan for the future, Dr. Stenzel suggested, “Information is power – we have to learn how to communicate with other specialties. There is also a competency issue – learn the basics and keep learning, because the field is going to keep changing in the future.”

Takeaways for the future

When Pratt asked for their final thoughts in a word, the panelists used collaboration, communication, involvement and evolution to describe the future of molecular pathology. These four keywords, along with feedback given both throughout the session, as well as during an after-session Q&A period, offer the optimistic viewpoint of an industry that has acknowledged the issues that exist and has accepted the challenges and opportunities that are yet to come.