On September 22, 2020 Genosity, Inc., an innovative biotechnology company that provides comprehensive software and technical solutions to enable precision medicine reported that it has entered into a strategic collaboration with Personal Genome Diagnostics Inc. (PGDx), one of the leading companies in cancer genomics, that recently received market clearance from the U.S. Food and Drug Administration (FDA) for PGDx elio tissue complete, a comprehensive diagnostic kit for genomic profiling of cancer (Press release, Genosity, SEP 22, 2020, View Source [SID1234565495]).
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Under the terms of this non-exclusive partnership agreement, PGDx and Genosity will collaborate to co-market their respective services and products. As part of the agreement, Genosity will incorporate the PGDx elio tissue complete assay into its software platform and professional consulting services. PGDx will co-market Genosity’s Integrated Genomic Toolkit (IGT) designed to support integration of next generation sequencing based testing into precision medicine programs across biopharmaceuticals, commercial laboratories, and health systems.
Genosity’s IGT SaaS solution is a HIPAA-compliant platform that supports end to end workflows for clinical next generation sequencing (NGS) along with EMR integration for return of results and data analytics. IGT is a modular platform built with independent but integrated applications, including Gateway, LIMS, Pipeline, Case Analyzer, and Cortex. Genosity will pre-configure the LIMS workflows for PGDx elio tissue complete assay to enable easier and faster implementation of wet-lab workflows with appropriate quality monitoring. In addition, Genosity will integrate its Case Analyzer application with PGDx’s bioinformatic pipeline to enable labs to integrate assay results into physician centric reports. Genosity’s Cortex organizes the genomic and clinical data in a knowledgebase to enable population-level analysis and cohort identification to support research collaborations.
"Genosity has established a novel software and technical approach that allows laboratories to more effectively implement genetic testing," said Dr. Marc D. Grodman, MD, co-founder and chief executive officer of Genosity."PGDx has gained approval for an important assay to help improve the outcomes of cancer patients. We see informatics as an essential component to allow greater adoption of genetic testing and we appreciate working with a partner like PGDx who is bringing best of breed testing to laboratories globally."
"PGDx elio tissue complete is a first of its kind FDA cleared kit to enable any molecular lab to perform comprehensive tumor profiling. Every lab is unique, but the importance of data integration is consistent in maximizing the value of NGS data in improving clinical care," said Megan Bailey, Chief Executive Officer of PGDx. "We’ve built the PGDx elio software to be flexible in meeting the integration needs of any lab. The addition of Genosity provides labs an option for a comprehensive solution, built from the ground up for the needs of molecular testing and NGS data."