Roche has introduced the Elecsys PRO-C3 test for evaluating the liver fibrosis severity in individuals with signs of metabolic dysfunction鈥揳ssociated steatotic liver disease (MASLD).
The Elecsys PRO-C3 test, developed in collaboration with Nordic Bioscience, provides clinicians with a simple method to identify liver fibrosis severity, which is essential for timely medical intervention.
Roche highlighted that until recently, lifestyle changes were the only management strategy for MASLD, as no specific medications were available.
The test operates on Roche’s cobas analysers and requires one assay, delivering outcomes in 18 minutes. This marks an improvement over existing diagnostic methods, potentially minimising healthcare expenses.
When used alongside the ADAPT formula, the test is said to offer a comprehensive evaluation of fibrosis severity.
The ADAPT score, which integrates PRO-C3 levels, age, platelet count and diabetes status, assists in distinguishing between significant and advanced fibrosis and cirrhosis.
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By GlobalDataThis differentiation is vital for selecting suitable treatment options and detecting candidates for emerging therapies.
Roche plans to introduce software later in the year to automate the ADAPT score calculation, further enhancing the diagnosis process for liver fibrosis.
Roche Diagnostics CEO Matt Sause said: “The Elecsys PRO-C3 test addresses an urgent need in the diagnosis, staging, and management of liver fibrosis.
“With MASLD affecting a growing number of people worldwide and new treatments emerging, it is critical to detect fibrosis accurately and early. Our innovative solution simplifies the diagnostic process and eases the burden on healthcare services, providing a clear and rapid assessment while reducing the requirement for invasive biopsies.”
Last month, Roche received breakthrough device designation from the US Food and Drug Administration for its computational pathology companion diagnostic VENTANA TROP2 (EPR20043) RxDx device.
