Prometheus Laboratories Inc, San Diego, Calif, has introduced the FibroSpect NASH test—a new tool to help healthcare providers stratify nonalcoholic steatohepatitis (NASH) patients by risk, based on the severity of their liver fibrosis.
NASH is a potentially serious condition that is related to the more common and less severe nonalcoholic fatty liver disease (NAFLD). It is estimated that one third of the US adult population may have NAFLD, with approximately 25% of those individuals progressing to NASH. As the incidence of these conditions grows, there is a critical need for noninvasive testing that measures the degree of fibrosis. Liver biopsy, an invasive procedure, is the current gold standard for diagnosing and staging liver fibrosis.
“As more effective therapies become available to treat NASH patients, having noninvasive blood tests to assess the severity of the patient’s fibrosis stage will allow us to better stratify their risk and select the most appropriate course of action accordingly,” says Manal Abdelmalek, MD, associate professor at the Duke University School of Medicine.
Advanced stages of liver fibrosis have been proven to be the most significant independent risk factor for mortality among NASH patients. FibroSpect NASH differentiates between mild and advanced liver fibrosis to help healthcare providers stratify the risk of their NASH patients and manage them accordingly.
Warren Cresswell, Prometheus Laboratories.
“The new FibroSpect NASH serum test overcomes some of the limitations of current invasive and noninvasive liver assessment methods by pairing expert-developed proprietary algorithms with biomarkers that are clinically relevant to the development of liver fibrosis specifically in NASH patients,” says Warren Cresswell, general manager and head of diagnostics at Prometheus Laboratories. “This is part of our new generation of diagnostic liver tests, based on scientific innovation and a strong investment, that anticipate and meet the changing needs of healthcare providers in the growing liver health category.”
The FibroSpect NASH test was developed and clinically validated with well-characterized and biopsy-confirmed NASH patients. The clinical validation data were presented this October at the 2017 meeting of the American Association for the Study of Liver Diseases, in Washington, DC.
For more information, visit Prometheus Laboratories.
