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BioFibroScore®

Noninvasive IVD for Liver Fibrosis Detection
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Application

BioFibroScore® is a research tool which has been shown accurate for staging liver fibrosis caused by HCV infection. The assay is also potentially applicable for additional forms of liver fibrosis caused by various diseases including HBV infection, fatty liver, and Nonalcoholic Steatohepatitis (NASH). In practice, additional applications for BioFibroScore® include monitoring liver fibrosis progressing and treatment decision.

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BioFibroScore®, an Non-invasive Alternative for Liver Biopsy

BioFibroScore® assesses liver fibrosis state by quantifying 3 biomarkers urokinase-type plasminogen activator (UPA), matrix metalopeptidase 9 (MMP-9), and beta-2 microglobulin (B2M) in the blood. Through a statistical algorithm based on the concentration of the 3 biomarkers, the assay could accurately determine liver fibrosis stages that are equivalent to the METAVIR score.

Urokinase-type plasminogen activator (UPA) is present in the blood and in the extracellular matrix of many tissues. UPA converts plasminogen into plasmin which triggers a proteolytic cascade involved in thrombolysis and extracellular matrix degradation. MMP-9, through its collagenase and gelatinase activity, plays a major role in the degradation of extra cellular matrix in both physiology and pathophysiology processes that involve tissue remodeling. Beta-2-microglobulin (beta-2-M) is associated with the heavy chains of class I major histocompatibility complex proteins that’s present in almost all nucleated cells. Serum beta-2-M levels are elevated in diseases associated with increased cell turnover and in conditions such as chronic inflammation, liver disease, renal dysfunction, and HBV infections

BioFibroScore® has been evaluated in 635 HCV-infected patients in comparison to percutaneous liver biopsy and FibroScan®. The assay was shown accurate to assess the stage of hepatic fibrosis. Applying this noninvasive test can substantially reduce the need for invasive liver biopsy.

Test Description

BioFibroScore® consists of 3 quantitative ELISA detecting serum level of UPA, MMP-9, and B-2-M, respectively. Each assay incorporates a set of quantitative standards to allow accurate determination of the biomarker concentrations which are combined and analyzed with a statistical algorithm to assess the stage of liver fibrosis.

Specimen Requirement

Patient Preparation – There is no specific requirement to the patients prior to blood drawn using standard venipuncture technique.

Specimen Preparation – Collect blood in SST tube. Serum should be separated from the red blood cells as soon as practical.

Storage/Transport Temperature – Store samples up to 48 hours at 2-8oC prior to assaying. Specimens held for longer time can be stored at -20oC for up to 6 months