Patricia Deverka, MD, MS, senior researcher, deputy director at the Center for Translational and Policy Research and Precision Medicine, University of California San Francisco, explains what multicancer early detection tests currently exist and the research needed to understand their clinical utility.
Patricia Deverka, MD, MS, senior researcher, deputy director at the Center for Translational and Policy Research and Precision Medicine, University of California San Francisco, explains what multicancer early detection tests (MCEDs) currently exist and the research needed to understand their clinical utility.
What access to multicancer early detection tests do patients currently have? How do they typically pay for them right now?
Currently, the only multicancer early detection test that's on the market is called Galleri, and the company website for Galleri indicates that providers and health systems and employers are their intended target audience. They have information about that. But it is currently not covered by insurance. The price listed on the website is $949 and it appears that self-pay is the only option. At this point, even though employers may be some of their target audience, it's unclear whether they could use their HSA [health savings account] or FSA [flexible spending account] accounts to pay for the test.
What additional testing and research is needed to understand the clinical utility and cost-effectiveness of liquid biopsy screening?
In terms of what additional testing and research is needed to understand the clinical utility of MCED testing, I think, first, there really needs to be a shared understanding of how we're going to even assess the clinical utility of these tests. Is it that each cancer will be looked at individually, so the clinical utility of screening for that type of cancer, or for the test as a whole?
If we all agree that clinical utility means studies that demonstrate that the test results affect clinical decisions and improve health outcomes, then can this be done across tumor types, some of which have current standard of care screening options, and others which do not? I think that's a whole very complex area where we just have to agree by what do we mean by clinical utility.
I really do think there need to be large, pragmatic clinical trials, such as those that are occurring now, like for the National Health Service in England with the Galleri tests that I mentioned earlier, as well as other real-world evidence studies that look at longitudinal outcomes across patient subgroups and health care delivery settings. Because, as I already mentioned, there is at least 1 test already on the market in the US and these studies are either in the planning stages or some of them are ongoing, I think that there need to be models that estimate the survival benefits of downstaging cancer detection across multiple cancer types. I think that will help to estimate the ability to detect multiple cancers simultaneously.