Accelerating the Promise of Precision Health
WHO WE ARE
GenPro is a precision health solutions company to the biopharma/biotech industry and to clinical research institutions, ultimately to clinicians and patients. As a leader in the discovery and commercialization of a powerful new class of clinically actionable biomarkers, epigenetic biomarkers, or EpiMarkers, GenPro is “opening-the-door” to a large underserved market need for sensitive, discriminating and personalized phenotypic-driven EpiMarkers and derivative assays for patient-disease characterization. GenPro’s EpiMarker discovery process also illuminates informative new molecular insights into disease causation and potential drugable targets that genomic analysis or genomic biomarkers do not provide.
Unique to GenPro is its proprietary cloud-based computational platform that combines advanced analytics and machine learning to rapidly discover novel patentable gene methylation EpiMarkers from patients’ blood, tissue, or tumor samples after whole genome NGS is performed on them. Novel EpiMarkers are then translated into low-cost, high throughput, easy to administer clinical tests plus a wealth of new epigenetic-driven molecular information about the genes involved, pathways, and MOA’s.
GenPro has successfully demonstrated its EpiMarker discovery and phenotypic characterization capabilities through several collaboration partnership agreements in multiple disease areas including oncology, neurology, neuro-degenerative, and endometriosis; and for applications such as patient stratification, early disease detection, diagnostics, and disease progression monitoring.
The most distinguishing capability of GenPro’s EpiMarkers are their ability to capture and leverage immune system epigenetic response to disease, disease progression and therapeutic intervention from patients’ blood (PBMC) samples. Although this capability is applicable across many diseases and applications, it is proving to be a particularly valuable difference-maker to biopharma oncology and immuno-oncology translation research and clinical development teams who are looking for solutions to match their new mono and combo immuno-therapeutics to patients who will respond positively.
GenPro’s therapeutic-specific EpiMarkers and their derivative panel assays disrupt the entire economic chain of clinical trials by enriching cohorts with potential responders that will greatly improve trial outcomes, accelerate new drug approvals and time-to-commercialization; reduce trial cohort sizes and trial costs; and provide a simultaneous development path for the drug’s companion/complementary diagnostic, followed by accelerated commercial adoption by physicians, patients and payers. These transformational capabilities are not possible with genetic markers of gene mutations or variants and related genetic-centric diagnostic panels and analyses that are prevalent in the market today.
Better Health by Decoding the Epigenome
WHAT WE DO
GenPro's quantitative analytics platform transforms the NGS value chain to yield both genetic variant calls (gene mutations) and our novel DNA methylation epigenetic biomarkers that enable clinical researchers to discover new therapeutic targets in their drug development pipelines, biopharmaceutical Investigators to conduct more timely and cost-effective clinical trial studies, and clinicians to tailor diagnostics and therapies to the needs of individual patients.
GenPro Analytics™, our proprietary, specialized software platform, employs genome-wide methylation profiling algorithms with machine learning support to discover novel epigenetic biomarkers with high positive prediction value that can be targeted in panel assays to allow scientists and medical professionals to predict, diagnose, and monitor the likelihood and progression of disease in individuals with much more sensitivity, specificity, accuracy, and cost-effectiveness than any other approach available today, including the popular tools in today’s markets that focus on genetic mutation panel profiling.
Capitalizing on the exponential growth in next-generation sequencing (NGS) and the rising interest in and rapidly expanding demand for epigenetic-profiling technologies to analyze and translate NGS data into actionable patient-care and treatment decisions, GenPro Analytics™ drives transformational improvements across the entire NGS value chain by adding a new epigenetic dimension to increase the scope of functional information derived from genome sequence data, all while seamlessly integrating with current industry standard NGS pipelines and workflows for NGS processing. From reducing the cost, time, and complexity of preparing genomic DNA (gDNA) for sequencing to delivering highly sensitive and accurate quantitative whole-genome methylation profiles with novel epigenetic biomarker identification and targeted assay development with either microfluidic qPCR platforms or gene capture and sequencing panels, GenPro's cloud based analytical services enable biopharma and diagnostic companies, clinical-care research institutions, and clinical trial programs to achieve game-changing improvements in personalized disease prediction, diagnosis, treatment, and stratification, all where a deeper understanding of the unique molecular and cellular makeup of individual patients is now necessary to make large differences in positive health care outcomes.
The GenPro advantage starts with the simple addition of our gDNA fragmentation strategy to an existing whole-genome sequencing workflow. The methylation sensitive restriction enzymes in our approach are matched to the GenPro Analytics™ methylation-profiling and biomarker-discovery software algorithms. Together, these technologies deliver results and provide answers that are superior to those obtained from the bisulfite oxidation approach typically used today.
GenPro’s integrated technology:
Does not destroy any DNA
Delivers all the whole-genome sequencing data required for variant analyses
Is less expensive
Delivers unequalled quantitative methylation sensitivity and accuracy at all CpG sites
Requires only one NGS run, not two (half the cost)
Identifies the highest confidence methylation sites for classifying patient phenotypes
Establishes a targeted assay for rapidly and cost-effectively screening these DNA methylation sites in larger patient cohorts
As a result of these advances, researchers have access to highly sensitive, accurate, and comprehensive quantified methylation profiles that are fully analyzed for statistical EpiMarker signatures and processed for targeted assay development all within one workflow stream at a fraction of the cost but with much higher precision and accuracy than currently employed technologies for either gene mutation calls or epigenetic based profiling tools. More importantly, GenPro Analytics™ quantified methylation profiles enable previously unachievable downstream value generated by the discovery of novel epigenetic biomarkers that enhance the effectiveness of patient stratification needs and applications in clinical trials and that can be subsequently used as companion or complementary diagnostic assays to improve positive health outcomes when a drug therapy reaches the market.
The most significant advantages of GenPro's technology are:
Versatility. From gDNA preparation using the GenPro gDNA prep kit through the discovery of novel epigenetic biomarkers using GenPro Analytics™, our portfolio of services comprises a single integrated solution that enables a superior standard NGS whole-genome sequencing strategy without chemically-induced (bisulfite oxidation) mutations. The NGS data produced from our technology can be used in standard genomic studies (SNPs, indels, alleles, etc.). But more importantly, we can derive a quantitative DNA methylation profile at each CpG location and extract from that data novel epigenetic biomarkers, something no one else can do as accurately, cost-effectively, or quickly.
Accuracy. GenPro's technology utilizes quantitative metrics for statistical processing. Our approach uses two lines of evidence in the raw sequence read files to reconstruct methylation status, resulting in more statistical confidence in our measurements for each CpG site.
Sensitivity. Statistical robustness and sensitivity are essential for biomarker discovery and diagnostic applications. Our approach is highly efficient in separating the epigenetic changes that signal shifts in health status from all the genomic noise and variability that exist between individuals. We leverage an advanced machine learning engine to classify the diagnostic performance of methylation sites to build the best targeted assay panel or plate for further clinical use on larger patient cohorts.
COLLABORATION PARTNERSHIP METHODOLOGY
Each biopharma and research collaboration partnership is tailored to the partner’s goals based on a staged, milestone-driven methodology commencing with a rapid, cost-effective and highly informative first stage to demonstrate EpiMarker discovery feasibility from ~50 patients. Conclusive results are provided in <12 weeks and are the basis for a go / no-go decision to advance to the next stages.
Stage 1 provides the foundational characterization of the novel EpiMarker, in particular the elucidation of the unique CpG signal that enables its phenotypic discriminating power. During Stage 1 a wealth of valuable new molecular insights are also illuminated such as the genes associated with the CpG sites that make up the EpiMarker signal, pathways, and mechanisms of action and potential targets.
Stages 2 – 5 involve a progression of activities to refine and validate the discovered EpiMarker using a larger patient cohort, translating it into an easy and inexpensive to deploy CLIA validated panel assay followed by the use of the assay throughout the trial and its concurrent development into a companion or co-diagnostic for use by clinicians once the therapeutic is approved.
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