In the IMvigor011 trial, the test that was used was a commercial test from the USA from the company Natera, and the test is called Signatera. And so it’s a tumor-informed ctDNA detection test. And what you need to do is you first profile a piece of the tumor tissue, say from the cystectomy, and then you design a custom assay that searches in that patient’s blood only for the mutations that are present in their cancer...
In the IMvigor011 trial, the test that was used was a commercial test from the USA from the company Natera, and the test is called Signatera. And so it’s a tumor-informed ctDNA detection test. And what you need to do is you first profile a piece of the tumor tissue, say from the cystectomy, and then you design a custom assay that searches in that patient’s blood only for the mutations that are present in their cancer. And it’s reasonably sensitive and it’s very specific. And I think an advantage in that trial was regular blood testing. But the challenge is how we’re going to implement that, especially outside of the USA, where those types of tests are not typically reimbursed. I think we have to do some cost-effective analyses and show how, you know, using this test helps you save money on treatment. And, you know, that might be one argument for covering the cost of tests. The other is I think it’s actually possible for hospital molecular pathology labs to implement this type of test. It is more difficult than what we normally do in our hospital molecular path labs, sort of more standard targeted sequencing, but it’s actually possible. And I think if we team up with our colleagues in GI and lung and breast, we can have enough of a case volume that could make it feasible.
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