Dr Peter Paul Yu: How Next-Generation Sequencing Is Changing Cancer Care

Next-generation sequencings tests are just starting to change the landscape for cancer patients, explained Peter Paul Yu, MD, FASCO, FACP, physician-in-chief, Hartford HealthCare Cancer Center.

Transcript

How is next-generation sequencing changing the landscape for cancer care?

Next-generation sequencings tests are just starting to change the landscape for cancer patients. We’ve had quite a bit of FDA and CMS regulation just in the first half of this year, which have begun to lay down the road map for how the FDA will look at laboratory diagnostic tests based on genomics and how they will go about ascertaining the quality of that test and how CMS is starting to think about how they will decide when they will pay for these tests. So, the fact that we have the 2 major regulatory agencies in the United States starting to set policy is a big step forward.

However, the payment policy issued by the National Coverage Decision by CMS a couple of months ago is extremely narrow. It essentially, as I interpret it, limits it to when there is a specific genomic biomarker match to a specific drug that’s been FDA approved. In that circumstance, combined with a patient with advanced cancer, there will be payment for it. But, it’s still a very, very limited role.

The alternative is that we rely on traditional biomarker testing, which is either a series of sequential tests that consume a lot of sample, and very often you may run out of sample before you’ve done all your testing, or some limited panel, which is increasingly being look at as both an inefficient and expensive way of doing genomic testing.

So, I think that it’s good news that the FDA and CMS are recognizing that requiring a specific companion diagnostic test for every single drug that is precision medicine-based is no longer the way to go. But, we’re not quite there yet.