Breakthrough device desig for Elecsys GALAD to diagnose HCCApril 4, 2020
Breakthrough Device Designation has been granted by US FDA to the Elecsys GALAD score to help diagnose liver cancer, Roche announced.
This algorithmic score combines gender and age with the biomarker results of the Elecsys AFP, AFP-L3 and PIVKA-II and is intended to aid diagnosis of early-stage hepatocellular carcinoma (HCC).
The Elecsys GALAD score will be the first GALAD score, with regulatory approval, for use in in-vitro diagnostics.
The Elecsys GALAD score has the potential to support clinicians by giving them more accurate information at an earlier stage, thus improving patient outcomes while being minimally invasive for people and potentially also more affordable to healthcare systems.
While recent developments in screening and new treatments are making advances in the prevention, diagnosis and treatment of HCC, clinicians still face challenges in diagnosing the disease early enough. Only 44% of liver cancer patients are diagnosed at an early stage, Roche said.