Thursday, August 30, 2018

Very Brief Blog: The Swing to FDA Approval: FMI Discontinues F1 Test for CDx Test

I may not be the first one to hear it but I heard today:  Foundation Medicine is officially turning off the production line on its F1 test.   According to its website, "On September 28, 2018, FoundationOne will be discontinued.  All [orders] will automatically be converted to FoundationOne CDx."

Website here.  This appears initially as a headline banner.   Web clip below. 

FMI's last SEC report (before its acquisition inside Roche) was in early August; unless I missed something, I didn't see an explicit reference to discontinuing F1.  In that report, it sounded like FMI was billing its CDx test to Medicare via Massachusetts and its LDT test to Medicare via North Carolina.   I don't know if the F1 discontinuation means its CDx supply line in Massachusetts can handle all volume or its North Carolina lab was upgraded to CDx. 

FMI will continue to provide Foundation Heme and Foundation Liquid Biopsy ("ACT") tests as LDTs for the present.