GenPro’s proprietary bioinformatics platform not only enables the rapid discovery of novel immune-system derived phenotypic biomarkers — EpiMarkers, that deliver novel clinical value such as responder prediction to therapeutics, early disease detection, and therapeutic efficacy monitoring.
The GenPro platform also generates rich epigenetic profiling data and information through tailored studies that illuminate valuable new epigenetic biological insights into genes, mechanisms of action, and pathways. The epigenetic profiling reports and data from tumor, tissue, blood, bone marrow aspirates, or any source of gDNA are opening a new channel of rich biological understanding that directly benefits drug discovery teams not only in oncology/immuno-oncology, but in all disease areas. Epigenetic profiling studies are tailored to each situation, typically take less than 10 weeks from GenPro’s receipt of samples to complete, and are performed using a proven sample-to-actionable results pipeline that produces a rich portfolio of data tables, graphics and analyses.
Translational research and biomarker discovery teams are a primary beneficiary GenPro’s immune-system-derived (not mutation-based) EpiMarker discovery solutions; the new biological insights that are illuminated during the EpiMarker discovery process; and the translation of EpiMarkers into low-cost/high-throughput precision panel assays for use throughout the clinical development phases, including as a CDx’s matched with a drug upon commercialization.
GenPro EpiMarker solutions open a big new source of biological insight into the immune system’s unique and informative functional response to the stress of a disease or disease change from its methylome imprint which GenPro “decodes” into novel EpiMarkers and informative epigenetic information. We achieve this by exploiting the immune system’s own biology — discovering and elucidating the external stressors that impact cell function in ways that create unique DNA methylation EpiMarker signatures reflecting their current biological state, and translating novel EpiMarkers into low-cost/high throughput panel assays for R&D and/or clinical trial patient selection uses.
GenPro’s minimally invasive blood-based EpiMarkers matched to pipeline drugs in development to identify patients who will be responders versus non-responders to a drug with a high degree of certainty and thereby enable better, more predictably successful clinical trial outcomes due to precision patient selection into clinical trials is GenPro’s primary value proposition to Clinical Development teams.
Further, EpiMarker enabled tests for clinical trial patient selection can also be advanced to be companion diagnostics for the drug throughout the clinical development and commercialization process. A big value add is the ability to do deep dive assessments into dynamic unforeseen biological variances and anomalies that happen throughout the clinical trial process to help pinpoint the precise DNA sites where diseases impact cellular health and function and/or to establish refined phenotypic classifications that mutation-based techniques cannot achieve.
GenPro is developing a pipeline of novel EpiMarker-enabled Immuno-Diagnostics that it will market directly and through collaboration partnerships with established Molecular Diagnostic Companies seeking to leverage their global marketing channels with valuable new clinical tests.
For Molecular Diagnostic companies who seek to rapidly expand into blood-based EpiMarker-enabled Immuno-Diagnostics in collaboration with GenPro, the value we bring is the ability to rapidly discovery and blind validate novel EpiMarkers in specific therapeutic and disease areas, then translate them into clinical tests that run on standard lab testing platforms, validate them through CLIA certification, and provide on-going technical and results processing support through the regulatory approval process and into commercialization. Our goal is to rapidly enable our Molecular Diagnostic partners with a growing pipeline of new tests that align with their long-term growth and market penetration goals. The scalability and performance of the GenPro Platform to rapidly and assuredly discover novel blood-based EpiMarkers is GenPro’s primary enabling advantage.
GenPro EpiMarker-Enabled Diagnostic Solutions are unparalleled in their ability to harness the sentinel power of the immune system, to provide a dynamic and deep information source for decoding epigenetic diagnostic patterns of health status from early disease detection to therapeutic responsiveness that can be easily translated into novel, minimally-invasive precision diagnostic blood tests in many diseases that mutation-based diagnostics cannot easily address.
GenPro’s unique scientific approach leverages a tightly disciplined workflow commencing with whole genome next generation sequencing (NGS) data to rapidly discover and blind-validate predictive epigenetic biomarkers from the immune system’s methylome, then enables their translation into low-cost/high throughput precision diagnostic tests. GenPro’s unique approach is delivering a superb success rate in the discovery of actionable diagnostic EpiMarkers in diseases such as Parkinson’s, cerebral palsy, AML, endometriosis, breast cancer, and NSCLC.
For Molecular Diagnostic collaboration partners who have specific business strategies to improve their positions in current markets or to enter new markets, GenPro starts with a staged collaboration engagement for one or several clinical tests. Engagements are “turnkey” and milestone driven from novel EpiMarker discovery through a CLIA approved clinical test that is ready for the regulatory approval process with an opt out provision if the blind validation of the newly discovered EpiMarker does not meet performance requirements. GenPro tailors on-going technical and results processing services to support regulatory development and approval as well as post-approval commercialization.
GenPro’s proprietary bioinformatics platform not only enables the rapid discovery of blood-based immune-system derived epigenetic biomarkers — EpiMarkers, that deliver novel clinical diagnostic clinical utility such as responder prediction to therapeutics, early disease detection, and precision diagnostics
The GenPro platform also generates rich epigenetic profiling data and information through tailored studies that illuminate valuable new epigenetic biological insights into genes, mechanisms of action, and pathways to expedite the discovery of new epigenetic diagnostics. The epigenetic profiling reports and data from tumor, tissue, blood, bone marrow aspirates, or any source of gDNA are opening a new channel of rich biological understanding that directly benefits diagnostic discovery teams in all disease areas. Epigenetic profiling studies are tailored to each situation, typically take less than 10 weeks from GenPro’s receipt of samples to complete, and are performed using a proven sample-to-actionable results pipeline.
Clinical Research Institutions
GenPro’s Epigenetic Profiling Services interpret the immune system’s natural response to diseases and are used by grant or government funded clinical research institutions to accelerate their investigations into a myriad of opportunities to better understand the role of the genome, epigenome, and metabolome in disease etiology, diagnosis, management and cure.
GenPro’s unique capabilities to provide epigenetic profiles that illuminate new insights into how immune cells interact with the dynamic biology of a disease — including cytokines, metabolite chemokines, and cell/tissue interactions - as well as deeply informative epigenetic profiles from any source of gDNA (tissue, tumor, bone marrow aspirates, etc) - are providing clinical research institutions who aspire to be at the leading edge of scientific knowledge about the role of epigenetics in human health with timely, cost-effective and rich new insights.
Research collaborations with Clinical Research Institutions are central to GenPro’s strategy to support advanced front-line epigenetic research opportunities through “turnkey” engagements tailored to each study and leveraging a growing portfolio of valuable tabular and graphic reports to accelerate new knowledge about genes, pathways, mechanisms of action and much more.