I've had the sense it has been mostly good news this year for pharmacogenetics - favorable scientific articles, favorable press, advances in coverage, and a new dedicated CPT code (for 6 or more PGx genes) which was just issued a final price of nearly $1000.
But here's a headline from Precision Medicine Online / Genomeweb:
- The well-known software vender Translational Software plans to shut down after receiving a negative result from its FDA 510(k) review.
- Here's an October 12 follow up at Genomeweb - here.
I haven't seen this yet on the Translational Software website. So the only source right now is the Genomeweb headline.
By October 8, a closure notice was up on the TS website:
I noted in my blog(s) on the FDA LDT proposals last week, that in the online FDA docket supplement (127pp), it made remarks about venders of software that support LDTs and that this multi-sourcing of LDT components was not being viewed favorably by the FDA. (Blog here, quote: "FDA is concerned that firms are offering IVDs as “LDTs” even when they are not LDTs, because they are not actually designed, manufactured, and used within a single laboratory.") ...Could or would the TS product have been cleared, absent this multi-sourcing concern? ...Could FDA navigate software that might give recommendations that are not found on FDA drug labeling? ...Did FDA think endorsement of the TS software seemed to indicate endorsement of the local LDT PGx tests that incorporate it? ...Where does clinical decision support in EHRs (CDS) stop and 510k software start? I don't know.
The extensive story by Turna Ray on the Translational Software events is on subscription.