Siemens' Fatty Liver Disease Blood Test Wins FDA De Novo Clearance

The FDA has granted clearance to a blood test from Siemens Healthineers SMMNY to provide an easier and potentially more accurate diagnostic alternative than an invasive tissue biopsy for non-alcoholic steatohepatitis (NASH).
The agency's de novo green light covers the Advia Centaur enhanced liver fibrosis (ELF) test, currently available internationally.
It measures three serum biomarkers of liver scarring and helps diagnose patients with mild-to-moderate liver fibrosis, typically asymptomatic.
Gilead Sciences Inc GILD supported the ELF Test De Novo Classification Request throughout the FDA review by providing scientific expertise, clinical study data, and resources.
Related content: Benzinga's Full FDA Calendar.
Price Action: SMMNY shares are down 0.08% at $35.61, and GILD stock is down 0.40% at $72.25 during the market session on the last check Tuesday.