Noninvasive PROMETHEUS® FIBROSpect® NASH Test Measures Severity of Liver Fibrosis

16 October 2017

SAN DIEGO, CA., October 16, 2017 – Prometheus Laboratories Inc. introduces 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 U.S. adult population may have NAFLD with approximately 25 percent of those 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.

Advanced stages of liver fibrosis have been proven to be the most significant independent risk factor for mortality in NASH patients. FIBROSpect NASH differentiates between mild and advanced liver fibrosis stages to help healthcare providers stratify the risk of their NASH patients and manage them accordingly.

“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,” said Warren Cresswell, General Manager and Head of Diagnostics at Prometheus Laboratories Inc. “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.”

“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,” said Manal Abdelmalek, M.D., Associate Professor at the Duke University School of Medicine.

The FIBROSpect NASH test was developed and clinically validated with well-characterized and biopsy-confirmed NASH patients. The clinical validation data is being presented at the 2017 American Association for the Study of Liver Diseases (AASLD) meeting, October 20-24, in Washington, D.C.

About Prometheus

Prometheus Laboratories Inc. is committed to improving lives through the development and commercialization of novel pharmaceutical and diagnostic products that enable physicians to provide greater individualized patient care. Prometheus is a leader in applying the principles of personalized medicine to the diagnosis and treatment of gastrointestinal diseases and is expanding product development to oncology testing. The company complements its proprietary diagnostic testing services with therapeutic products. By integrating therapeutics and diagnostics, Prometheus provides physicians with more targeted solutions to optimize care for their patients. Prometheus became part of Nestlé Health Science in 2011. For more information about Prometheus, please visit www.prometheuslabs.com.

PROMETHEUS, the Link Design, For the person in every patient, and FIBROSpect are registered trademarks of Société des Produits Nestlé S.A. Vevey, Switzerland.

- Prometheus Press release