Yeah, and there are several next steps that we need to take. So there are several gaps in our knowledge, but it’s also that we are about halfway in the development pipeline going up to clinical implementation.
So if you go at the very end, before clinical implementation, we have to address issues like regulatory approval, getting reimbursement, for example, inclusion in guidelines, clinical guidelines, but there are also technical developments that we need to address...
Yeah, and there are several next steps that we need to take. So there are several gaps in our knowledge, but it’s also that we are about halfway in the development pipeline going up to clinical implementation.
So if you go at the very end, before clinical implementation, we have to address issues like regulatory approval, getting reimbursement, for example, inclusion in guidelines, clinical guidelines, but there are also technical developments that we need to address. So it’s important that we will arrive at a in vitro diagnostic test. So that’s a kind of, yeah, quality label of robustness of a test. So that needs to be done as well.
There are other issues. For example, we need to do a real worlds analysis. For example, know how it fits in the diagnostic practice. What’s the added value for the physician? Do they feel comfortable? What are the cutoffs, is also something we need to establish. And so far, the studies have been performed, merely in Caucasian populations, and we need to include more diverse populations because there are also indications that the cutoffs may differ among different ethno-racial groups. So these are a few issues to address, but there’s still more to do.
