Molecular Stethoscope, Inc. Announces Presentation of Primary Sclerosing Cholangitis (PSC) Study at the AASLD Liver Meeting 2021


Molecular Stethoscope, Inc., a Precision Medicine biotechnology company, announces presentation of its human proof-of-concept study applying its proprietary cf-mRNA Liquid Biopsy Technology Platform for the study of Primary Sclerosing Cholangitis (PSC) at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting – The Liver Meeting 2021. This study demonstrates the utility of the Company’s Technology Platform to identify dysregulated gene clusters in PSC patients and develop classifiers using liver-enriched cf-mRNA transcripts for PSC diagnosis.

Naga Chalasani, M.D., who is the lead author of this study and Professor of Gastroenterology and Hepatology and Interim Chair in the Department of Medicine at Indiana University in the USA, commented that, “The identified, usually inaccessible, pathological gene clusters may inform response to candidate medicines in present clinical trials, as well as suggest future therapeutic targets; and the liver-enriched classifier may have utility for non-invasive molecular stratification of PSC patients for pharmacotherapy safety and response studies.” And Dr. Chalasani added, “New molecular tools to timely diagnose PSC in patients with ulcerative colitis is a critical unmet need.”

The study is titled “Noninvasive molecular characterization of primary sclerosing cholangitis using cell-free messenger RNA sequencing,” and it will be presented during The Liver Meeting 2021 session “PBC/PSC and Other Cholestatic Diseases.”

Primary Sclerosing Cholangitis (PSC) is a rare chronic disease of the bile ducts with an unknown cause and unpredictable course that results in scars and inflammation of the biliary system. Patients with PSC may develop severe liver problems including cirrhosis, cancer and the need for a liver transplant. Specifically, PSC patients are at increased risk for cholangiocarcinoma, hepatocellular carcinoma and colorectal cancer. With limited therapeutic options and a lack of proven monitoring strategies, there is a significant clinical unmet need for PSC patients.

Guillermo Elias, Ph.D., Chief Executive Officer at Molecular Stethoscope stated, “We are excited to share the positive results of this PSC study with the medical and scientific communities. Together with our previously completed and published human proof-of-concept studies in NAFLD/NASH, Alzheimer’s Disease and Cancer (Transplant Oncology), this PSC study further de-risks our Technology Platform. We are now focused on building our clinical-grade pipeline to accelerate the development of products and solutions for clinical practice and BioPharma R&D.”

More information about the results of this study is available in the AASLD Liver Meeting 2021 website:

Publication Number: 1283. “Noninvasive molecular characterization of primary sclerosing cholangitis using cell-free messenger RNA sequencing.”


Molecular Stethoscope, Inc. Announces Presentation at 16th Annual Sequencing to Function: Analysis and Applications for the Future Meeting


Molecular Stethoscope, Inc., a Precision Medicine biotechnology company, announces a presentation at the 2021 16th annual Sequencing to Function: Analysis and Applications for the Future Meeting (SFA2F) at the Los Alamos National Laboratory in Santa Fe, New Mexico, USA. SFA2F is a meeting dedicated to bringing together leading scientific, translational medicine and clinical experts in the genomics and next-generation sequencing technology fields with the goal of advancing applications for the future. The study is entitled “Spiked in ERCC controls and integration of simulated RNA-Seq data for the analysis of cell free messenger RNA to study the variation for a clinical-grade multi-transcript classifier” and will be presented by lead author John J. Sninsky, Ph.D., Chief Scientific Officer at Molecular Stethoscope.

The presentation will take place in digital format to accommodate the evolving COVID-19 Global Pandemic circumstances. More information can be found at the SFA2F Meeting website:

“RNA-Seq for cell-free mRNA (cf-mRNA) represents the next frontier in liquid biopsy for clinical practice and Precision Medicine BioPharma Research and Development. Clinical-grade RNA-Seq assays must be more accurate and robust than research-grade RNA-Seq assays since the results inform patient management,” commented Dr. Sninsky, CSO. This study highlights key technical elements of the Company’s proprietary cf-mRNA Liquid Biopsy Technology Platform that non-invasively harnesses data from dynamic gene expression changes from major organs. First, the integration of spike-in RNA controls developed by External RNA Controls Consortium (ERCC) for sequence read normalization provided critical measurement assurance of dynamic range and limit of detection for a clinical-grade assay required for clinical-grade assays. Second, the high correlation of 14 replicate results of a clinical sample and the correlation of replicate results of a liver fibrosis classifier for the company’s successful human proof-of-concept study in Non-alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis (NASH) supports the reproducible performance of the Technology Platform. Third, a description of bioinformatics pipeline leveraging clinical-grade DNA-Seq pipeline guidelines and recent FDA review of best-in-class differential expression RNA-Seq software. Fourth, a proposal to model overall read uncertainty from combined biological variation, preanalytical variation, analytical variation and postanalytical variation for clinical-grade assays to assist interpretation for clinical practice and BioPharma R&D.

“Building on our successful peer-reviewed and published human Proof-of-Concept studies in NAFLD/NASH, Alzheimer’s Disease, and Transplant Oncology, we are transitioning our research platform to a clinical-grade capability to accelerate the development of products for clinical practice and BioPharma R&D,” added Guillermo Elias, Ph.D., CEO of Molecular Stethoscope. “We are committed to leading the development of the Next-Gen cf-mRNA Liquid Biopsy Technology by adhering to the ethos of rigorous scientific methodology in our on-going translational medicine efforts to build novel products and solutions to significantly improve human health,” added Dr. Elias, CEO.