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Future Needs and Challenges of Multi-Cancer Early Detection Tests
Implementation challenges and the importance of equitable access in the future of multi-cancer early detection tests.
Transcript:
Elizabeth O’Donnell, MD: And so going back to you, Dr Beer, can you briefly discuss the future needs surrounding the MCED [multicancer early detection] test?
Tom Beer, MD, FACP: Well, I’d like to focus on 2 areas. One is the current considerations and challenges associated with implementation. And the second is what do we need to do to make sure that these tests are deployed in an equitable manner? With regard to implementation, there are many unanswered questions today that remain to be clarified with trials that are ongoing or planned. We need to sort out what is the optimal frequency of screening, as you alluded to earlier, Dr O’Donnell. We need to sort out what is the best diagnostic resolution strategy following a positive MCED signal. We have a lot of work to do to help patients understand and set tests in the context of currently available standard of care screening. It will be important that pivotal trials are conducted that enable FDA approval of these tests so that they can become widely available and accessible, and then it will be important for us to continue to gather real-world evidence that will complement clinical trials and enable us to learn more about the performance of these tests in real clinical settings and not just in a controlled setting of a clinical trial….
Elizabeth O’Donnell, MD: We’ve talked about a lot of issues around health care inequities. And so I was wondering what you thought was needed to ensure health inequities are addressed.
Tom Beer, MD, FACP: I think addressing health inequities with MCED means that we need to design a test with everyone and for everyone. And that is a unique meaning for MCED tests that might be a bit distinct from some of the other areas of medicine. That is because MCED tests are designed using patient specimens to calibrate the test itself. And so making sure that at those very early stages, at the level of the case-control studies, we have a diverse group of participants representing all of us. Participating is critically important so that the test is designed from the beginning for everyone. Then, of course, we need the pivotal studies to be inclusive and to evaluate the test performance in everyone, and that is the basis on which we are. We have the hope of gaining the trust of all Americans in MCED testing. FDA approval is also a crucial goal. There is really no practical way to bring MCED tests to the broad population in a manner that’s affordable without FDA approval and broad-based reimbursement. And then there is a lot of work to do on education. Both clinicians and patients [who are considering] cancer screening really need to grow an understanding of MCED tests. This is a complex new area. An understanding of current screening tests did not happen overnight. And so we have a lot of work to do to educate people about how these tests are performed, what they do, what they don’t do, and where they fit into our efforts to reduce the burden of cancer.
Transcript is AI generated and edited for readability.
