Molecular Stethoscope Inc, a precision medicine biotechnology company, announces publication of its human proof-of-concept study describing the stratification of NAFLD/NASH patients with clinically relevant and advanced liver fibrosis using the company’s Next-Generation cell-free mRNA Liquid Biopsy Technology Platform. The study titled “Non-invasive Stratification of Non-Alcoholic Fatty Liver Disease by Whole-transcriptome Cell-free mRNA Characterization” was published in the American Journal of Physiology – Gastrointestinal and Liver Physiology, a journal of the American Physiological Society. The first author is Naga Chalasani, M.D., Professor of Gastroenterology and Hepatology and Interim Chair in the Department of Medicine at Indiana University in the USA. Dr. Chalasani is the leading author of the AASLD Practice Guidelines for the diagnosis and management of NAFLD/NASH disease.
“Once validated in larger studies, non-invasive Liquid Biopsy diagnostic solutions such as the ones being developed by Molecular Stethoscope may be used serially not only as Drug Development Tools to monitor the ongoing challenging pharmacotherapy clinical trials, but also to follow cf-mRNA changes during lifestyle modification which has led to marked improvements in steatosis and fibrosis,” commented Dr. Chalasani.
There continues to be a concerted effort to accelerate the translation of innovative technologies to clinical studies and patient management. Consistent with this, the diligent efforts by the USA National Institute of Standards and Technology (NIST), biotechnology consortia and the USA-FDA have made foundational strides in establishing best practice Next Generation Sequencing, RNA-Seq and Machine Learning that will accelerate the translation of the Molecular Stethoscope Technology Platform into products for clinical practice.
The substantial unmet clinical need in NAFLD/NASH has spurred a $1.4B investment by numerous Pharma/Biotech companies with 125 interventional clinical trials now recruiting subjects. In addition, the USA-FDA has encouraged the development of Drug Development Tools to monitor efficacy of pharmacotherapies that target multiple mechanisms of action.
“Clinical interventional studies for NAFLD/NASH have multiple challenges. The Liver Forum, a collaborative non-competitive group of stakeholders from academia, regulatory agencies, professional societies, patient organizations, and industry stakeholders, has recommended standard reporting of baseline parameters and standardization of diet and exercise information to facilitate cross-trial analysis, an important step in validation of Non-Invasive Tests for this serious common chronic liver disease,” added Veronica Miller, Ph.D., the founder and Director of the Forum for Collaborative Research and a Professor (Adjunct) at the UC Berkeley School of Public Health.
“The publication of this important study positions us to move forward with the next phase of product development to have a significant impact on NAFLD/NASH clinical practice and in Pharma/Biotech R&D to improve the health of patients,” commented Guillermo Elias, Ph.D., Chief Executive Officer at Molecular Stethoscope.