Cofactor Genomics, a clinical RNA sequencing and translational assay developer, announced today that its laboratory has successfully completed a rigorous validation of ImmunoPrismTM, its comprehensive, quantitative, solid tumor immune-profiling assay, certified by the College of American Pathologists (CAP). In testing, the ImmunoPrismTM assay successfully met all performance criteria, which included sensitivity, specificity and reproducibility standards. As one of the only clinical laboratories specializing in RNA-based assays, Cofactor Genomics has worked closely with the College of American Pathologists in recent years to establish criteria specific to RNA-based assays. Today’s announcement follows previous 2018 releases highlighting work with ImmunoPrismTM (formerly called Paragon) with top-tier cancer centers, including The National Cancer Institute (NCI) and the Fred Hutchinson Cancer Research Center.
“Working closely within the guidelines set by the College of American Pathologists (CAP), Cofactor leveraged its expertise in RNA-based testing to carry out a robust assay validation and quality assurance plan. The ImmunoPrismTM assay provides highly accurate and reproducible results from routine formalin-fixed tissue paraffin embedded tissue (FFPE) with a much higher sensitivity than conventional protein-based methods,” said Eric Duncavage, MD, medical director, Cofactor, and Associate Professor, Director of Hematopathology at Washington University in St. Louis.
Cofactor’s ImmunoPrismTM assay reports on the most impactful immune modulatory molecules demonstrated to have implications in drug discovery, biomarker development and immunotherapy efficacy prediction. Speciﬁcally, ImmunoPrismTM details the quantitative percentage for each of eight major immune cell types. This immune characterization can be obtained using FFPE, FNAs, CNBs, accommodating solid tumors with very limited tissue, as is often the case with pre-treatment clinical samples, which previously have been difficult to characterize.
“The CAP validation of our ImmunoPrismTM assay further strengthens our position as leaders in bringing the next generation of molecular assays into the clinic,” said Jarret Glasscock, PhD, founder and chief executive officer. “By enabling clinicians and researchers to interrogate nearly all clinical specimens with a sensitivity and specificity previously unattainable, ImmunoPrismTM can enhance patient outcomes through more precise identification and treatment of solid tumor cancers.”
Cofactor’s COO, David Messina, will share more during a panel discussion titled, “Building the Best Biomarker-Driven Precision Medicine Clinical Trials” at the Clinical Biomarkers and World CDx Meeting in Boston on October 4.
About Cofactor Genomics
Cofactor Genomics uses RNA to help researchers and clinicians understand, diagnose, and predict drug response for the 95% of disease that can’t be assessed by DNA alone. Founded by three former Human Genome Project scientists, Cofactor has built a database of multidimensional gene expression models and a proprietary platform capable of overcoming the chemical and computational challenges of performing complex characterization of clinical-grade human samples. Cofactor has contracts to provide RNA sequencing and analysis services to the research arms of eight of the world’s largest pharma and biotech companies and is in the process of commercializing a suite of clinical diagnostic assays. Find out more about Cofactor Genomics at cofactorgenomics.com.
Continuum Health Communications/ICR