ZURICH (Reuters) – Roche has won fast-track review status in the United States for a new diagnostic approach the Swiss drugmaker hopes will support its push into treating liver cancer with drugs including its immunotherapy Tecentriq.
The company said on Wednesday that its Elecsys GALAD score, which combines factors including age, gender and biomarker results to more quickly and accurately diagnose early stage hepatocellular carcinoma (HCC), was awarded U.S. Food and Drug Administration’s (FDA) Breakthrough Device Designation.
“The combination of blood-based biomarkers with clinical algorithms has the potential to significantly reduce mortality of HCC patients as they can receive a more timely diagnosis and treatment,” said Roche Diagnostics head Thomas Schinecker.
Roche is targeting HCC, the most common type of liver cancer and a big killer of people particularly in Asia and Africa, with a cocktail of Tecentriq and its older drug Avastin that has been submitted for FDA approval. Some 750,000 people globally are diagnosed with HCC annually, in particular in countries hit hard by chronic hepatitis B or where a cancer-causing mould called aflatoxin contaminates food such as rice, Roche said. Almost half of HCC cases are in China, one of the company’s fastest growing markets.
The FDA Breakthrough Devices Program was created in 2018 to speed the development and prioritize review of technologies that may help treat or diagnose devastating diseases or conditions better than existing products.
(Reporting by John Miller, editing by John Revill)