Standard BioTools Proteomics Identifies Unique NASH Biomarkers

Researchers from Pfizer Research and Development have published a paper in Nature Scientific Reports detailing their use of Standard BioTools Inc.'s advanced SomaScan® Assay to investigate nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). The study utilized a comprehensive 7,000-protein biomarker panel to analyze blood serum samples from patients participating in a Phase 2a clinical trial.

NAFLD and NASH are significant global health concerns due to their complex effects on the liver, such as lipid accumulation, tissue stiffness, ballooning, and chronic inflammation. Diagnosing these conditions typically requires invasive liver biopsies, which are both difficult and costly. Consequently, many patients remain undiagnosed and untreated.

SomaLogic (now Standard BioTools) has previously collaborated with leading pharmaceutical companies and academic institutions to develop the SomaSignal™ tests. These tests offer a more accurate correlation with liver biopsy components than other noninvasive biomarkers. Operating on the SomaScan® Platform, which measures thousands of proteins, these tests allowed researchers to infer biopsy effects and identify additional protein biomarkers to understand drug mechanisms and treatment responses.

According to Stephen A. Williams, MD, PhD, Chief Medical Officer of Standard BioTools, the prevalence of metabolic and obesity-related diseases has intensified the urgency to better understand and treat NAFLD and NASH. The SomaScan Assay enables a deeper insight into the biological mechanisms of these diseases through a simple blood draw, and SomaSignal tests have demonstrated value in showing disease regression.

The study specifically examined the effects of clesacostat, an acetyl-CoA carboxylase inhibitor, on liver disease. Using the SomaScan Assay, researchers identified 69 blood biomarkers that were strongly associated with clinical measures of liver inflammation and steatosis. They found that the expression of these biomarkers was significantly higher in NASH patients compared to those with NAFLD.

Furthermore, in the pre-treatment phase involving 231 patients, the SomaSignal tests measured 37 analytes correlating with NAFLD and NASH. These tests helped researchers categorize patients by disease severity, establish a baseline before treatment, and monitor drug effects. These 37 analytes were identified by screening thousands of patient samples and validated against standard clinical measurements.

During the 16-week trial, participants received a daily dose of clesacostat. The SomaSignal test scores were in alignment with improvements in liver fat content as measured by MRI-PDFF. Twenty-seven analytes showed significant reversal upon drug treatment, highlighting the utility of SomaSignal tests for classifying NASH and understanding the effects of ACC inhibition on steatosis.

Michael Egholm, PhD, President and CEO of Standard BioTools, noted that the SomaScan Platform has been extensively validated, providing a robust foundation for this research. He emphasized that the SomaSignal tests were instrumental in better diagnosing NASH and NAFLD patients and studying their treatment responses.

Standard BioTools now offers the SomaScan 11K Assay, in addition to industry-leading single-cell and spatial proteomics solutions (CyTOF® and Hyperion™ platforms). These offerings aim to assist customers in identifying predictive biomarkers, understanding mechanisms of action, and stratifying patients in clinical studies.

Standard BioTools Inc. is dedicated to accelerating breakthroughs in human health through its advanced technologies. The company's portfolio includes mass cytometry and microfluidics technologies, which provide crucial insights into health and disease, aiding biomedical research and improving patient outcomes. The company collaborates with leading institutions worldwide, focusing on pressing needs in translational and clinical research, including oncology and immunology.