Roche's Elecsys GALAD Blood Test Receives FDA Breakthrough Device Designation for Early Hepatocellular Carcinoma Diagnosis

On the 5th, Roche announced that the U.S. FDA had granted Breakthrough Device Designation to its Elecsys GALAD score assay, to support the early diagnosis of hepatocellular carcinoma (HCC) patients.

Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer, typically occurring in patients with chronic liver disease, such as cirrhosis caused by hepatitis B or C virus infection. HCC affects approximately 500,000 people worldwide, with the highest incidence rates in Asia and Africa. China bears a substantial burden of HCC, accounting for more than half of all cases globally. According to statistics cited in the press release, only 44% of liver cancer patients are diagnosed at an early stage, and the five-year survival rate for those with advanced-stage disease is less than 16%. However, early screening and treatment can increase the five-year survival rate to 70%.

Currently, the primary screening methods for patients with liver cirrhosis are ultrasonography and measurement of alpha-fetoprotein (AFP) levels. Approximately half of patients with advanced hepatocellular carcinoma (HCC) exhibit elevated AFP levels. AFP is a protein produced during early fetal development, as well as by the liver and various tumors, including HCC. However, these tests have lower sensitivity for early-stage disease compared to advanced-stage disease. Furthermore, AFP levels can be influenced by other factors, such as pregnancy and other types of tumors, potentially leading to misdiagnosis.

Image source: 123RF

The algorithm for the Elecsys GALAD test integrates patient gender, age, and biomarker levels of AFP, AFP-L3 (a subtype of AFP), and des-γ-carboxy prothrombin (PIVKA-II) to facilitate early diagnosis of hepatocellular carcinoma. As a blood-based diagnostic approach, it is minimally invasive.

“We are pleased that the U.S. FDA has recognized the potential clinical benefits of the Elecsys GALAD assay in the early diagnosis of hepatocellular carcinoma,” said Thomas Schinecker, CEO of Roche Diagnostics. “The combination of blood-based biomarker levels with a clinical algorithm holds significant potential to reduce mortality among HCC patients by enabling more timely diagnosis and treatment.”

References:

[1] FDA grants Breakthrough Device Designation for Roche's Elecsys GALAD score to support earlier diagnosis of hepatocellular carcinoma, Retrieved March 04, 2020, from https://www.roche.com/media/releases/med-cor-2020-03-04.htm

Original Title: Express | Earlier Diagnosis of Liver Cancer! Roche Blood Test Receives FDA Breakthrough Device Designation

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