Breakthrough Device Designation to the Elecsys® GALAD score intended to aid diagnosis of early stage hepatocellular carcinoma

Breakthrough Device Designation to the Elecsys® GALAD score intended to aid diagnosis of early stage hepatocellular carcinoma

https://finance.yahoo.com/news/fda-grants-breakthrough-device-designation-060000829.html
  • The Elecsys GALAD score aims to support clinicians in diagnosing hepatocellular carcinoma by giving them more timely and accurate information to make earlier interventions. 
  • When hepatocellular carcinoma is detected and managed at the very earliest, patient’s 5-year survival rates can increase to over 70%
  • Utilizing blood-based biomarkers, as part of the Elecsys GALAD score, is minimally invasive to patients.
  • The GALAD score is a serum biomarker-based model that predicts the probability of having hepatocellular carcinoma in patients with chronic liver disease. This combines gender and age with the results from assays AFP, AFP-L3 and PIVKA-II to give the clinician a clearer picture of HCC risk.
  • In chronic liver diseases, such as hepatitis and cirrhosis, Alpha1-fetoprotein (AFP) may be chronically elevated. Very high concentrations of AFP may be produced by certain tumors. This characteristic makes the AFP test useful as a tumor marker. AFP-L3 is a subtype of AFP and can be used to differentiate an increase in AFP due to HCC, or benign liver disease. PIVKA-II is a precursor and abnormal form of prothrombin that is found in patients with HCC. This can be used to differentiate HCC from non-HCC hepatic diseases.PIVKA-II is an alternate name for des-gamma-carboxy prothrombin (DCP).