The FDA has granted Breakthrough Device Designation to Thermo Fisher Scientific’s (NYSE:TMO)
Oncomine Precision Assay to identify low-grade glioma patients with
isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations who may be
suitable for Agios Pharmaceuticals’ (NASDAQ:AGIO) vorasidenib.
The designation, akin to Breakthrough Therapy
status for a drug, provides for more intensive guidance on development
by the FDA, the involvement of more senior agency personnel, the
assignment of a case manager and priority review of the marketing
application.
The companies have been collaborating on companion diagnostics since 2017.
https://seekingalpha.com/news/3582922-thermo-fisher-nabs-accelerated-review-in-u-s-for-glioma-test
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