Elizabeth O’Donnell, MD, and Tomasz Beer, MD, FACP, recap key takeaways from the panel and consider the potential of MCED testing in transforming cancer screening and addressing gaps in early detection.
Elizabeth O’Donnell, MD: So, Dr Brewer, we’ve covered a lot of topics, and a lot of it is so exciting. Could you briefly provide a recap of the discussion and discuss what’s on the horizon? What is the future of MCED [multicancer early detection] testing?
Tom Beer, MD, FACP: Well, it’s been a really rich and robust discussion. I learned a lot from my colleagues. Just to recap some of the highlights, cancer is the second leading cause of death in the United States, and it’s on track to become the leading cause of death by 2030. And today, two-thirds of cancers and cancer deaths occur due to cancers for which we do not have guideline-recommended, standard of care screening. Vulnerable, underserved populations are experiencing even higher cancer incidence and mortality rates than the general population.
Multicancer early detection tests in development have the potential to be a paradigm shift in cancer screening. They’re being designed to complement standard of care screening tests, enabling the early detection of cancers for which no standard-of-care screening tests are available today. They are built upon an analysis of molecular signals derived from cancer and measured in the blood. These tests are designed to be implemented as a single blood draw with very high specificity to limit false positives and as high as possible sensitivity for early-stage cancers, where intervention is most likely to save lives. We expect if successful, MCED tests will expand the range of screening-detected cancers well beyond the current 4 cancers for which we have agreed-upon recommended screening tests and enable more detection of early-stage cancers where effective intervention can save lives.
We think MCED tests, if successful, can make a meaningful and important contribution to the White House Moonshot goal of reducing cancer mortality by half within 25 years. The data from clinical studies today show that we’re getting closer. It’s now been demonstrated that MCED tests can detect cancers with no recommended screening options at early stages, and that early detection by MCED test has enabled treatment with curative intent. But more work remains to be done to further define MCED test performance and its contributions to human health.
Elizabeth O’Donnell, MD: It’s wonderful. And what do you see as an implication of the varied approaches that we’ve been discussing for them regarding MCED test design and diagnostic resolution for both patients and providers?
Tom Beer, MD, FACP: Well, the goal is to accurately detect and confirm cancers in early stages when curative interventions are possible. So with that goal in mind, we know that screening tests need to have high sensitivity for early-stage cancers and very high specificity to avoid false positive signals. We’ve heard about 2 approaches today to the development of MCED tests, one that involves 4 biomarker classes and one that focuses on 1 biomarker or class. Cancer confirmatory testing, accuracy, and a simple path for the provider with diagnostic resolution [are] also important. And we’ve heard of 2 possible approaches in development: One that’s anchored around a molecular tissue of origin suggestion, and another that focuses on the application of imaging. The tests that do this best will help us to make progress against the Cancer Moonshot goal that aims to reduce cancer mortality in half within 25 years.
Elizabeth O’Donnell, MD: And finally, my last question for you is what further work is needed to really harness the potential benefits and MCED testing and fill the current gaps in cancer screening?
Tom Beer, MD, FACP: While we’ve talked about a lot of exciting data, we’re really still at relatively early stages of the development of MCED tests, with many unanswered questions regarding MCED tests on the market and development. Some of the questions that we need to answer include: What is the most appropriate frequency of screening? What is the best diagnostic resolution pathway for patients and for providers? What about patient perceptions of MCED tests? Will patients stick with their proven standard of care screening tests as they should, even as they take advantage of MCED tests? What about anxiety and its impact on psychological well-being?
Pivotal trials need to be done to demonstrate the value of these tests in support of seeking FDA approval, which is a prerequisite for broad availability. And real-world evidence will complement these pivotal trials and enable us to learn more about how these tests perform in the real world and enable us to improve our strategies for implementation of these tests if they prove to be safe and effective in pivotal trials.
Transcript is AI generated and edited for readability.