This new product will help pharmaceutical companies to assess drug safety risks, inform go/no-go decisions in lead selection, and expedite drug discovery programs
Westbury, NY –BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced the launch of its XPRESSWAY® Profile Safety Package, a compendium of 46 gene expression profiles for genes known to play pivotal roles in drug safety assessments. Those 46 genes are included in the initial screening panel used by pharmaceutical companies to evaluate new chemical entities (NCEs) for potential off-target interactions and toxic effects.1 Pharmaceutical companies routinely evaluate the binding and /or function of NCEs on these targets to determine their drug safety risk and make go/no-go decisions in their lead selection programs.
“BioIVT is always looking for ways to support our customers and help inform strategic decisions in the drug discovery process. We developed the XPRESSWAY Profile Safety Package to provide additional context for pharmacology screening data and allow sponsors to make go/no-go decisions regarding NCEs more efficiently. We also partner with customers to conduct custom gene expression studies that further support lead selection and optimization,” said Amanda Woodrooffe, PhD, Vice President and General Manager, PHASEZERO® Research Services at BioIVT.
Once NCEs have been screened against the 46 gene targets, the XPRESSWAY Profile Safety Package allows the resulting binding data to be compared with the corresponding human target expression profiles and interpreted further to assess potential safety risk. When NCEs bind to the targets, the tissue distribution of those targets can inform decision-making about the compounds and chemical series.
BioIVT’s XPRESSWAY Profile Safety Package serves as a reference guide and includes stellar plots showing the quantitative gene expression for each of the 46 genes in 72 human tissues representing the adipose, cardiovascular, central nervous system, endocrine, gastrointestinal, hemochorial, hemolymphoid, integumental, musculoskeletal, reproductive, respiratory, and urinary systems.
By providing gene expression data by tissue type, the XPRESSWAY Profile Safety Package allows researchers to incorporate their knowledge of the pharmacokinetics and distribution of their NCEs into the potential risk assessment. It enables them to determine whether the NCE will be present in the tissues where the off-target binding could occur. As data are grouped by organ category, XPRESSWAY also enables gene expression patterns across the “whole human” to be viewed at a glance.
BioIVT’s XPRESSWAY Profile Safety Package contains all 46 profiles in both hard copy and electronic format. It includes the profile patterns and electronic delivery of all raw data with primer-probe sequences, donor details, Ct data for the target and duplexed GAPDH PCR control, and interpolated gene copy number.
BioIVT employed a rigorous, highly-controlled qRT-PCR method to develop the XPRESSWAY Profile Safety Package’s gene expression data. It is a tried and tested approach; BioIVT has already used it to generate data for more than 2,300 human genes with excellent assay performance. Profiles for all the genes are available in a BioIVT database and the data quality and reproducibility have been independently verified by pharmaceutical customers.
Customers use BioIVT’s database profiles to interpret target expression and support target validation, and also to identify novel or unexpected expression that may indicate either safety liability or an opportunity to repurpose a drug acting on that target.
BioIVT can also develop expression profiles for new genes or splice variants, or to compare target expression across species.
BioIVT’s XPRESSWAY Profile Safety Package will be demonstrated at booth #3804 at the Society of Toxicology (SOT) Annual Meeting and ToxExpo, which will be held from Mar. 10-14 at the Baltimore Convention Center in Baltimore, MD. Further information about the meeting is available at https://www.toxicology.org/events/am/AM2019/index.asp.
- Bowes et al. Nature Reviews in Drug Discovery. 11(12):909-922.
BioIVT, formerly BioreclamationIVT, is a leading global provider of research models and value-added research services for drug discovery and development. We specialize in control and disease-state biospecimens including human and animal tissues, cell products, blood, and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples. Our PHASEZERO® Research Services team works collaboratively with clients to provide target and biomarker validation, phenotypic assays to characterize novel therapeutics, clinical assay development and in vitro hepatic modeling solutions. And as the premier supplier of ADME-toxicology model systems, including hepatocytes and subcellular fractions, BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly-discovered compounds and their effects on disease processes. By combining our technical expertise, exceptional customer service, and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in elevating science. For more information, please visit www.bioivt.com or follow the company on Twitter @BioIVT.
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