ProSciento said today it will combine its predictive screening methodology and clinical protocol with Nordic Bioscience’s biomarker technology in a collaboration designed to improve the diagnosis, prognosis and development of therapeutics for nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH).

Under their collaboration—whose value was not disclosed—the companies plan to identify and validate translational biomarkers by combining ProSciento’s NASH PASS patient registry with Nordic Bioscience’s Protein FingerPrint technology.

NASH PASS combines a proprietary screening methodology using biomarkers, predictive algorithms, and a broad range of assessments—as well as an IRB-approved clinical protocol, and a patient registry of current diagnostic data. NASH PASS is intended to diagnose and differentiate between healthy, NAFLD and NASH with a single blood draw, as well as use imaging modalities or liver biopsy in a highly predictive manner.

ProSciento—a clinical research organization (CRO) exclusively focused on NASH, diabetes, obesity and related metabolic diseases—said its NASH PASS registry includes more than 1,000 screened individuals. The company works with select, prequalified clinical centers across the U.S. to establish opt-in routine screenings of patients at high risk for the development of the NASH, such as patients diagnosed as obese or with type 2 diabetes, within their primary care setting.

The screening assessment data is used, according to ProSciento, to determine patient eligibility for clinical research, as well as identify individuals with NASH from a high‐risk population who will progress to imaging or biopsy procedures.

Nordic Bioscience said its Protein FingerPrint has delivered a broad range of novel and proprietary protein biomarkers for applications in the diagnosis and prognosis of important diseases. Most of these biomarkers detect structural components of the extracellular matrix (ECM) and have been validated in clinical studies of patients diagnosed with musculoskeletal disorders, fibrosis and cancer, according to the company.

One example cited by Nordic Bioscience: Its PRO-C3 biomarker detecting neoepitope fragments of Collagen Type III has shown an association with poor prognosis in fibrotic liver diseases, such as NAFLD and NASH, and will be further assessedthrough the partnership with ProSciento.

“We’re very pleased to be partnering with Nordic Bioscience to combine the scientific insight from our access to real-time, longitudinal patient data and biological samples and their cutting-edge biomarker discovery expertise. ProSciento CEO Marcus Hompesch, M.D., said in a statement. “Bringing together our areas of expertise specific to NASH research provides a much-needed opportunity to gain a better understanding of disease progression and establish new diagnostic and prognostic biomarkers to support safe, effective drug development.”

Added Nordic Bioscience CEO Morten Karsdal, PhD: “ProSciento’s expertise conducting NASH clinical studies and patient access via its NASH PASS program, combined with the complementary expertise and technology at Nordic Bioscience, promises to make this a transformative collaboration for the advancement of NAFLD/NASH research.”

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