COMy 2026 | ClonoSEQ in myeloma: how does it fit into a patient-centric diagnostic pathway?

So clonoSEQ is a highly sensitive minimal residual disease testing method which can detect down to one in a million tumour cells amongst normal bone marrow cells still. And of course, as such, it is a monitoring tool for disease responses that’s much better than what we could ever at the moment achieve with a peripheral blood test. It is likewise at the same time a bit the limitation. We have to use it very carefully in the right position in the treatment pathway and for the right patients to really derive the most information for a patient because we have to do a bone marrow biopsy, which is not the most pleasant investigation for a patient. So it makes really sense to take a step back and to think about what is the information that we want to derive from such a MRD test when we use it in clinical care. We do know that we can use it a lot in, for example, the regulatory setting. And we’re now looking at whether drugs may be approved faster by using it in a whole group of patients. But when an individual patient comes to us, of course, the question is a different one. That patient wants to know, what does the test mean for me? Does it mean that I need to have more treatment, that I can have less treatment? We have been thinking about this for quite a while, and we have actually just launched a new diagnostic pathway at the Royal Marsden Hospital called MyTrack Myeloma. And the idea here is that clonoSEQ forms an essential part of it, but it’s actually embedded in a whole suite of tests, which include enhanced risk profiling up front before a treatment starts, which includes genetics, but also gene expression risk profiling and a whole-body MRI for patients. So that we really, really know as much as we can, which patient is at risk of an early relapse. And then the clonoSEQ information, of course, gives wonderful information about the depth of response. And we know that about half of our patients don’t have a risk of early relapse. For these patients the depth of response is particularly important and they might guide us on an individual decision basis and really guide patients that are keen to reduce their treatment intensity whether the time point is right once they have had enough treatment. So, we are now evolving really to see through the concept of MyTrack that we need a set of diagnostics that are really used at the right time, at the right place to get the right treatment to the right patient.

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