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Biomarker Development Overview
Discovery, Development & Commercialization
PGxHealth has developed industry leading know-how and experience in translating the science relating to genetic marker discovery to valuable applications in the clinical setting. The division is accustomed to discovering and in-licensing proprietary markers including but not limited to those in CNS, cardiovascular, and oncology. Once the genetic marker is known, and clinical utility is evident, PGxHealth has the experience to validate and commercialize genetic tests based on these markers. The genetic markers that are developed and included in PGxHealth’s test catalog are chosen for commercialization based PGxHealth’s assessment of their economic and clinical value to the key consumers of these tests (including patients, providers, payors). In addition, we work directly with those developing therapeutics to identify genetic markers, incorporate the markers into their commercialization plan, and PGxHealth is positioned to commercialize the resultant genetic tests for our clients as well in the same manner we commercialize our own genetic tests. PGxHealth is committed to funding its in-licensing, development and commercialization of these genetic tests but will continue to work with others to accelerate discovery and development where a strategic fit exists.
Why PGxHealth
PGxHealth has vast experience and capabilities in genetic marker discovery and validation. Our know-how in biomarker discovery is the foundation for development of our novel diagnostics that lead to safer and more efficacious therapeutics. PGxHealth has a long history of discovering and validating biomarkers for both the development of its proprietary diagnostics and for collaborations with pharmaceutical, biotechnology, and academic partners. Our Company has built a unique expertise and infrastructure to discover and validate genetic markers predictive of therapeutic response and to develop these into genetic tests. PGxHealth has years of experience planning and conducting prospective and retrospective clinical trials that maximize the chances for successful identification of clinically meaningful genetic markers. This experience includes the development of appropriate informed consents and IRB approval for use globally.
PGxHealth is also a leader in genomics capabilities with experience conducting whole genome scans and candidate gene-based approaches, including the identification of candidate genes through expression analyses. Our proprietary HAP® Database, additive to the publicly available HapMap, includes genetic information for >8000 genes, including genes that contribute to therapeutic response in all major therapy categories. For each of these genes, we have data for 79 unrelated individuals who are members of five ethnic groups that are common in the United States (Native Americans, African-Americans, Asian-Americans, European-Americans and Hispanics/Latinos). By performing polymorphism discovery on this diverse sample, we have identified most of the common variants that are found in populations from around the world, most of which are not present in public databases. The haplotypes, into which the variants combine, are almost completely unknown in the literature or in public databases. We have also developed proprietary software to rapidly screen genetic variants for their utility in genetic tests. This knowledge provides PGxHealth with a distinct advantage over those who are relying exclusively on publicly available genomic data.
For more information on our biomarker discovery and development capabilities, marker discovery in which you can participate, or in order to better understand how PGxHealth can further your endeavors in biomarker discovery, please click our e-mail link info@PGxHealth.com or call use toll-free at
1-877-2-PGXHEALTH (877-274-9432).
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