Multicancer early detection tests What we know/ What we don't Access vs Payment

It’s a real problem that FDA approval is routinely treated as a proxy for a reimbursement decision when that is explicitly not something FDA looks at. It’s frustrating to me, as someone whose wheelhouse is much more FDA approval than insurance coverage, to look up the reimbursement question and consistently be told it’s technically not a proxy. Then people who know the system talk as if it mostly is, especially for Medicare with the extra Medicare carve-out here. Private insurance and Medicaid are different, but the same thing still happens. So approval stops being a narrow access question and seems to become a value judgment, even though it can’t be openly deliberated that way. The access question (in terms of FDA approval) can be debated separately, but that debate by design stays on evidence standards (endpoints, trial design, quality) and informed choice. It does not go into cost, value, and system impact. The two decisions are set up as separate. In practice they are not treated that way, no matter what the technical answer is. I really don’t know what the answer is. If after all these years it seems that in practice, for some reason, they can’t be decoupled, do we accept that they are linked, or do we try to make the system do what it’s actually supposed to do? And since this is a lab test, there is the added complication of it being offered as an LDT versus needing FDA approval.

Great presentation and obviously this is an uncharted territory. The test can point to cancer origin with 93% accuracy, I believe, so we don’t really have to dig around in the dark that much.

All this rolling out when premiums at record highs, millions transitioning to Medicare, and every agnostic adult I know absolutely and overtly panicked over mere mention of death. Good times 😁

Galleri detects cancers that shed in blood. Cancers that shed in blood are the ones that are growing. If galleri detects a cancer, it is a growing cancer, therefore it is likely not benign.

This is amazing analysis. Who is on the panel who can understand these very basic concepts ? Me guessing -NONE. Vinay stay true to science. Stray away from the political BS. Change through education

Access matters, but so do the facts. Families deserve to know what a test can actually tell them, what it can't, and what a positive result actually means before the high costs of repeat tests become the norm. Informed decisions require the full picture.

Multicancer ctDNA testing creates all of the same problems as "PSA only recurrence after prostatectomy" but with an even higher level of diagnostic and therapeutic uncertainty.