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: https://www.lanl.gov/conferences/sequencing-finishing-analysis-future/index.php
“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.