Benzinga | Aug 24, 2021 01:22PM EDT

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

* The FDA has granted clearance to a blood test from Siemens Healthineers (OTC: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 (NASDAQ:GILD) supported the ELF Test De Novo Classification Request throughout the FDA review by providingscientific 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.