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The products/features (mentioned herein) are not commercially available in all countries. Their future availability cannot be guaranteed.
INNOVANCE VWF Ac assay is under review by FDA as a de novo classification request. An approval is pending and the product is not yet commercially available in the United States.
In the U.S., the ELF Test is indicated as a prognostic marker in conjunction with other laboratory findings and clinical assessments in patients with advanced fibrosis (F3 or F4) due to non-alcoholic steatohepatitis (NASH) to assess the likelihood of progression to cirrhosis and liver-related clinical events. The test is not for use in the diagnosis of NASH or for the staging of fibrosis.