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.
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Posted In: NewsHealth CareFDAGeneralBriefsNon Alcoholic steatohepatitis
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