In my last Map of Biomedicine blog post, I discussed companion diagnostics and the FDA approval process for such tests. In this post, I’ll be talking a little bit about research use only (RUO) tests and use that to segue into a discussion about a kind of test that is going to turn diagnostic testing on its head.
The distinction between RUO tests and the clinical tests we’ve been discussing is pretty simple. RUO tests are used only in research studies with consenting participants. The big catch is that the results of the tests won’t be used to change the patient’s treatment. On top of that, the results are often anonymized so that the researcher doesn’t even know who the participants are.Read More