RE:RE:Great News RecapSlimchange wrote: He also mentioned they are going into a phase (can't remember what it is specifically called)
LDT is probably what you refer to:
https://www.fda.gov/medical-devices/vitro-diagnostics/laboratory-developed-tests
Indeed Artistotle is validated on 10 000 patients already through the sentinel principle. if I am not mistaken, LDT garantees that you can sell your tests and FDA acceptance is probably for being able to reach insurance programs more easily.
Since they plan to launch Aristotle with Mercer, I would say that it's looking very good for that.