The FDA has granted Breakthrough Device Designation to Roche’s (OTCQX:RHHBY) Elecys GALAD score as an aid in diagnosing early-stage hepatocellular carcinoma (HCC).
The company says the algorithmic score combines
gender and age with biomarker results from three tests, Elecsys AFP,
AFP-L3 and PIVKA-II, to provide clinicians with a clearer picture of HCC
risk.
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.
https://seekingalpha.com/news/3548454-roche-liver-cancer-test-nabs-accelerated-review-status-in-u-s
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