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Addressing Healthcare Inequity With Accessible Multicancer Early Detection
The potential of MCED testing to reduce health inequities and an examination of accessibility, including FDA approval, physician education, patient awareness, affordability, and logistical support.
Transcript:
Elizabeth O’Donnell, MD: So this comes back to the preceding question…. Dr Beer, how might MCED [multicancer early detection]testing reduce some of the health inequities we see in screening?
Tom Beer, MD, FACP: The tests are still quite new. So we’re all working toward a better understanding of the role that they’ll play in general and the role that they can play in closing gaps that have emerged over the years. One of the key considerations is that the tests in development today are all blood-based, typically single blood-draw tests, which in general should be relatively more accessible than more complex screening tests. But we have to be really thoughtful and careful to make sure that this promise is realized. We know historically that new technologies have often widened disparities and gaps in care rather than narrowed them. So in addition to making it a relatively simple and accessible test, we have to be very mindful that the test is broadly available and accessible to all.
Elizabeth O’Donnell, MD: What is it that we need to do to ensure that MCED testing is accessible?
Tom Beer, MD, FACP: There is no broad accessibility without broad reimbursement. This test has to be broadly available at an affordable cost to Americans. That begins with FDA approval. It’s hard to imagine broad reimbursement for a screening test that is not FDA approved. Getting a test that the FDA agrees is safe and effective is really the key first step. But there’s a lot more to do. We have to raise physician awareness about these new technologies. This is really a new approach, and we should not underestimate how large an effort was undertaken to educate our physician workforce about the current screening tests that we think of as routine today.
But they did not start out as routine when they first became available. We need clear information and education on the intended-use populations…so that clinicians are confident in recommending those tests. We need to address the lack of information and misinformation among patients about what access can and cannot do. We need to make sure [patients] understand that they’re not a replacement for proven standard-of-care tests. We need to make sure [patients] understand what a positive result and a negative result mean for their care. [As with] most health care, we need to address basic logistical issues of access, transportation, and logistics—of getting into a clinician’s office and getting access to tests. We need to make sure that tests are affordable….
Certainly, when follow-up colonoscopy became available without a co-pay for those individuals who have a stool-based screening test for colon cancer, that signals a positive result. So we need to be very mindful of the out-of-pocket costs that [patients] will encounter and make sure that financial assistance programs are available for those in need. And we need to support patient navigation through this new diagnostic pathway…. You know, I think manufacturers of the tests also should ensure that the tests are efficacious for a broad range of members of our population, hopefully for average-risk [individuals,] where we can have the greatest impact with these tests. And that requires developing clinical evidence that demonstrates safety and efficacy in those populations. I think it’s necessary for this to be a team sport. It’s not the job of just academics or just test manufacturers to spread the word about these tests and to educate and work toward making them accessible. There’s room for advocacy organizations such as the American Cancer Society, Prevent Cancer Foundation, and others to weigh in as well.
Elizabeth O’Donnell, MD: [Would] you please provide a brief overview of the testing platforms that are currently available or under development?
Tom Beer, MD, FACP: So right now, I think the 2 platforms that are best known are the Galleri test from GRAIL and the multicancer early detection test being developed by Exact Sciences. There are other test developers working in this space, but these are the two that have been put to the test in relatively large-scale prospective clinical interventional studies. We’re beginning to learn something about their performance in the clinic. These tests have some things in common.
They’re both blood tests that are administered as a single blood draw and provide a result within a couple of weeks. They have some differences as well. They evaluate different biomarker classes. The Galleri test is focused on a deep interrogation of DNA methylation. The Exact Sciences test uses multiple biomarker classes to look for a cancer signal. There are some differences in how a positive result is worked up or diagnostically evaluated. And of course, the tests have not been compared with one another, and research is ongoing. There is a lot yet to learn about these tests. Both of them have been evaluated in feasibility or pilot studies. But definitive large-scale prospective clinical trials that really show us what the test performance is, what the test safety is, and how we see its contribution to cancer early detection are still ahead.
Transcript is AI generated and edited for readability.
