Pharma

Roche launches digital liver disease panel for fibrosis and cancer risk assessment

Roche has launched a new Liver Disease Panel, a suite of certified digital algorithms and biomarker-based tools designed to support the diagnosis and management of chronic liver disease, a condition that affects an estimated 1.5 billion people globally.

The panel combines routine laboratory biomarkers with digital health algorithms to help clinicians identify liver fibrosis earlier, assess disease severity and support surveillance for liver cancer. Roche said the platform is aimed at improving clinical decision-making across different stages of chronic liver disease management, particularly in conditions such as metabolic dysfunction-associated steatotic liver disease (MASLD), metabolic dysfunction-associated steatohepatitis (MASH) and hepatocellular carcinoma (HCC).

The launch comes at a time when chronic liver disease is increasingly being driven by metabolic disorders. Roche said MASLD now affects 38% of the global population and is becoming the fastest-growing cause of liver cancer worldwide. The company said many patients remain undiagnosed because early-stage disease often develops without symptoms, delaying intervention until advanced stages such as cirrhosis or liver cancer.

“At every stage of their journey, patients with chronic liver disease need effective care,” Matt Sause, CEO of Roche Diagnostics, said in a statement. He said the Liver Disease Panel would help clinicians identify risk earlier and manage the disease more effectively.

A key component of the panel is LiverPRO, a CE-marked algorithm developed in collaboration with health technology company Evido. The algorithm uses a patient’s age and at least three out of nine commonly available blood-based biomarkers to assess the risk of liver fibrosis. Roche said the tool is designed to work with routinely available laboratory data, reducing dependence on invasive testing methods.

The company said LiverPRO has been endorsed in the European Association for the Study of the Liver (EASL) Patient Trajectory Guidance as an alternative first-line test for liver fibrosis. According to Roche, the technology is intended to standardise patient referrals and speed up the identification of high-risk patients through a non-invasive approach.

The broader Liver Disease Panel also integrates Roche’s Elecsys PRO-C3 biomarker with the ADAPT algorithm to assess fibrosis severity. Additional tools include the GAAD algorithm combined with Elecsys AFP and Elecsys PIVKA II to aid in the diagnosis of hepatocellular carcinoma. The platform also incorporates established clinical scoring systems such as the FIB-4 Index, MELD Score, ALBI Score, Child-Pugh Score and the Lille Model.

Roche said the panel has been integrated into its navify Algorithm Suite, allowing clinicians to access and review algorithm results within existing hospital systems. The company added that all algorithms within the platform are clinically validated, certified and integrated into clinical workflows.

The Liver Disease Panel will initially be available across European markets. Roche said the launch forms part of its broader strategy to expand digital diagnostics and non-invasive tools for chronic liver disease management.

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