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.
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:
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:
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.
Nicholas (Nic) Dracopoli, Ph.D. is Chief Scientific Officer at a seed stage cancer diagnostics company based in Baltimore, MD, and he also serves as a consultant to several other early stage diagnostic and oncology companies. Previously he was Senior Vice President of Translational Sciences at Personal Genome Diagnostics (PGDx). For the prior eighteen years, he served in leadership oncology drug development roles at Bristol Myers-Squibb (BMS) and Janssen Pharmaceuticals. In these roles, he was responsible for building two new translational science teams whose work contributed to the approval of several new oncology drugs. Prior to leaving Janssen Nic was Vice President, Head of Oncology Diagnostics and Vice President, Head of Oncology Translation Research.
Before joining the pharmaceutical industry, he spent five years in the biotechnology industry at Sequana Therapeutics. Nic obtained his bachelor’s degree and doctorate from the University of London and completed post-doctoral fellowships at the Memorial Sloan-Kettering Cancer Center in New York City, NY and the Massachusetts Institute of Technology (MIT) in Cambridge, MA. Subsequently, he served as an Assistant Director at the Whitehead/MIT Genome Center and as a Section Chief at the National Center for Human Genome Research at the National Institutes of Health, Bethesda, MD. Nic has authored more than 70 scientific publications and has extensive experience in the fields of genomics, molecular biology and cancer research.
Dr. Goel has spent more than 20 years researching cancer and has been the lead author or contributor to over 240 scientific articles published in peer reviewed international journals and several book chapters. He is also a primary inventor on more than 15 international patents aimed at developing various biomarkers for the diagnosis, prognosis and prediction of gastrointestinal cancers. He is currently using advanced genomic and transcriptomic approaches to develop novel DNA- and microRNA-based biomarkers for the early detection of colorectal cancers. In addition, he is researching the prevention of gastrointestinal cancers using integrative and alternative approaches, including botanical products such as curcumin (from turmeric) and boswellia.
Dr. Goel is a member of the American Association for Cancer Research (AACR) and the American Gastroenterology Association (AGA) and is on the international editorial boards of several journals including Gastroenterology, Clinical Cancer Research, Carcinogenesis, PLoS ONE, Scientific Reports, Epigenomics, Future Medicine, Alternative Therapies in Heath and Medicine, World Journal of Gastroenterology. He is also actively involved in peer reviewing activities for more than 100 international scientific journals and various grant review panels of various national and international funding organizations. His research has been actively funded by various private and federal organizations, including funding from the National Cancer Institute (NCI) at the National Institutes of Health (NIH), American Cancer Society (ACS) and other state organizations. He has won more than dozen awards and honors, including the Union of European Gastroenterology Federation’s Distinguished Researcher Award, multiple Poster of Distinction Awards from the AGA, and Visiting Professorships from various national and international academic institutions and academic bodies. Some of his key research interests include:
Dr. Landais earned is Ph.D. at Universite Louis Pasteur, Strasbourg, France and his MBA at UCLA. Dr. Landais has extensive biopharma R&D oncology new drug discovery and development experience stemming senior scientific leadership positions with Sanofi early in his career. After Sanofi he served on the executive teams of several biotechnology companies, mostly focused on strategy, business and corporate development. Prior to joining Servier, Dr. Landais was GenPro’s Chief Business Officer. He is a seasoned executive in research & development, project management, GMP manufacturing and business development with 20 years of experience in biotech and pharmaceutical industries and has extensive knowledge of the market environment (especially in Oncology) that includes broad experience in pharmaceutical product development, biomarkers, research, manufacturing, financial planning, intellectual property, and market assessment. More specifically, he is adept at leading the international development of a therapeutic product (Ph II trials in Europe and US), managing BLA and MAA filings for biological products, negotiating and closing deals (licensing and M&A), initiating research and clinical collaborations with academic institutions and biotech companies, designing and executing Business & Marketing Plans, developing strategic international negotiation skills and experience, including 15 years in the US, defining new business channels/partnerships and strategies, contacting and forming relationships at executive level, and leading cross-functional teams.LinkedIn
Dr. McCormack is Principal of RMCC, LLC, where he advises companies in liquid biopsy development and testing. Bob is also a member of the FNIH Cancer Steering Committee and co-leads its efforts to develop well-validated reference materials for ctDNA testing.
Dr. McCormack has thirty years of invitro diagnostics experience in clinical, regulatory, medical and scientific affairs. He served in R&D leadership positions at academic institutions, small biotechs, large diagnostic companies, and in the pharmaceutical sector. While at J&J he was a founding member and General Manager of Veridex, LLC, Cellular Technologies, which helped define the liquid biopsy space. Prior to Veridex he was Head of Biomarker Strategy for the Disease Interception Group in Janssen Pharmaceutical R&D, and Vice President of Clinical Affairs for Ortho-Clinical Diagnostics.
Dr. McCormack received his BS degree from the University of Wisconsin, River Falls, and his MS and PhD degrees from the University of Minnesota.
Dr. Christopher Mason completed his dual B.S. in Genetics and Biochemistry (2001) from University of Wisconsin-Madison, his Ph.D. in Genetics (2006) from Yale University, and then completed dual post-doctoral training in clinical genetics (2009) at Yale Medical School, and a joint post-doctoral Fellow of Genomics, Ethics, and Law at Yale Law School (2009). He is currently an Associate Professor at Weill Cornell Medicine, with appointments at the Tri-Institutional Program on Computational Biology and Medicine between Cornell, Memorial Sloan-Kettering Cancer Center and Rockefeller University, the Sandra and Edward Meyer Cancer Center, and the Feil Family Brain and Mind Research Institute.
The Mason laboratory develops and deploys new biochemical and computational methods in functional genomics to elucidate the genetic basis of human disease and human physiology. We create and explore novel techniques in next-generation sequencing and algorithms for: tumor evolution, genome evolution, DNA and RNA modifications, and genome/epigenome engineering. We also work closely with NIST/FDA to build international standards for these methods, to ensure clinical-quality genome measurements/editing. We also work with NASA to build integrated molecular portraits of genomes, epigenomes, transcriptomes, and metagenomes for astronauts, which help establish the molecular foundations and genetic defenses for enabling long-term human space travel.LinkedIn
Dr. Serum received a B. A. in Chemistry from Hope College in 1965 and was awarded a Ph.D. degree in Organic Chemistry in 1969 from the University of Colorado. His doctorate research was directed toward studies in Mass Spectrometry. Following his graduate studies, he taught and did research at the University of Ghent, Belgium. He spent a year at Rice University as a Welch Fellow, and then joined the staff at Cornell University as Director of the National Institutes of Health High Resolution Mass Spectrometry Facility.
Dr. Serum joined the Hewlett-Packard Company in 1973 as Applications Chemist for Mass Spectrometry. Since then he has held a number of management positions, including Technical Support Manager for Mass Spectrometry in Europe (Paris, France); Marketing Manager for Mass Spectrometry and Spectroscopy at the Scientific Instruments Division; R&D Manager at the same division; and R&D Manager for the Avondale Division (Laboratory Automation and Chromatography Instrumentation). Since 1984 he has held Business Unit level positions as Operations Manager for Laboratory Automation Systems, Automated Chemical Systems Operation and Analytical Group Research & Development Manager. In 1992 Dr. Serum was named General Manager for Mass Spectrometry, Infrared, and Protein Chemical Systems. He was the founder of HP’s Bioscience Products business. He has served as chairman of HP's Bioscience Council, co-chairman of the Hewlett-Packard R&D Council and the Pharmaceutical Business Council. He retired from Hewlett Packard in August 1999 to co-found Viaken Systems Inc, where he was a Director and served as Executive Vice President and Chief Operating Officer. Dr. Serum has been a Venture Partner with Flagship Ventures and until retiring in 2011, served as President of Scitek Ventures, a science and technology consulting firm that he founded in 2002. In 2002 he was elected as a lifetime National Associate of the National Academy of Sciences and in 2004 he was elected to serve on the Visiting Committee for Advanced Technology of NIST. In 2005, Dr. Serum was named to the President’s Advisory Board for Advanced Technology at the Research Corporation. He has served as a member of the Board of Directors for a number of emerging technology based companies. In 2008, he was elected as Chairman of the Visiting Committee for Advanced Technology for NIST. Dr. Serum retired from his company, Scitek Ventures in 2011. He remains actively involved in the future of science and technology in the US and has testified several times in Congress related to this topic. In 2013, Dr. Serum organized and chaired a National Workshop at NIST on advanced technology related to an improved measurement “diagnostic” for Lyme disease. Although officially retired, Dr. Serum remains active in research collaborations with Johns Hopkins Medical School and NIST involving improved detection methodologies for Lyme disease. He is also a science and business advisor to a young company, GenPro, involving technology for detection of a variety of very early stage cancers and other diseases. Dr. Serum serves on the Board of Directors of the non-profit organization, tranSMART Foundation, which is a member-driven non-profit foundation developing an open-source / open-data community around the tranSMART and OpenBEL translational research platforms.LinkedIn
Ian was formerly with Siemens Healthcare Diagnostics where he was VP, head of the Strategic Innovation group where he had global responsibility for Siemens innovation growth strategy earning industry-wide regard for his expertise. Prior to taking the Chief Strategy Officer for the Precision Medicine Initiative at Cedars Sinai, Ian was Chief Science Officer of Cedar Sinai’s Advanced Clinical Bio-Systems Institute. His career spans over 30 years in life-science commercialization and technology development. Ian has been a valued advisor to GenPro since its founding in 2014.LinkedIn
Newark, Delaware – Nicholas (Nic) Dracopoli, Ph.D, an experienced leader in oncology translation research, biomarkers and diagnostics has joined GenPro’s Scientific Advisory Board as the outside lead.
According to Nic, “What captured my interest is GenPro’s science and technology’s ability to rapidly discover a powerful new category of phenotypic biomarkers based on epigenetic responses to different cancers and diseases. There is a huge unmet clinical need in the exploding immuno-oncology field and across the disease spectrum for precision biomarkers that mutation markers cannot easily address. GenPro’s immune-system derived EpiMarkers are well positioned to exploit this opportunity.”Read More
HemOnc Feb 2018 - GenPro & Delaware's Helen F. Graham Cancer Center Discover novel EpiMarker with Potential to Predict Invasive vs Non-invasive DCIS Breast Cancer. Click Here for Article.
GenPro, a precision heath solutions company pioneering the discovery and commercialization of a new class of biomarkers, epigenetic biomarkers, from blood samples and their translation into actionable assays and information to enable biopharma companies focused on immuno-oncology to dramatically improve the selection of patients into their clinical trials who will respond to their new immuno-therapeutics today announced that its Chairman, CEO and Co-founder, Jeb Connor, will present at the Biotech Showcase ™ 2018 Conference in San Francisco, January 8–10.Read More
PharmaTech Outlook Selects GenPro to be Among 2017's Top 10 Solution Providers to Biopharma Discovery and Development Organizations - November 2017. Details can be found at: 2017 Top 10
USA Today Reports...Christiana Care Health System's Center for Translational Cancer Research in Collaboration with GenPro Discover Epigenetic Biomarker-Enabled Blood Test to Prevent Overtreatment of Early Stage Breast Cancer - October 2017.
The work will be presented in a poster session at the NAACR Conference in Washington DC on Tuesday, April 4, 2017 from 8:00AM - Noon in the poster area in Halls A-C of the Convention Center. It is Section 15, Poster #30, Abstract #3369 which is part of the Epigenetics 3 Section of the Molecular and Cellular Biology & Genetics Session. The project is titled, "Epigenetic DNA Methylation Profiling of Triple Negative Breast Cancer: A Quantitative NGS Approach".Read More
Two renowned leaders in oncology epigenetics recently joined Genome Profiling’s (GenPro’s) Scientific Advisory Board. Christopher Mason, Ph.D., is Assistant Professor of Integrative Functional Genomics, Clinical Genetics and Synthetic Biology at Weill Cornell Medical College in New York. Ajay Goel, Ph. D. has also joined the GenPro Scientific Advisory Board. Dr. Goel is Professor and Director of Baylor Health's Scott and White Center for Gastrointestinal Research and the Center for Translational Genomics and Oncology.Read More
Epigenetics is a rapidly developing field focused on deciphering chemical fingerprints that accumulate on human genomes over time. In this paper, GenPro reports a novel quantification methodology for computationally reconstructing site-specific CpG methylation status from next generation sequencing (NGS) data using methyl-sensitive restriction endonucleases (MSRE). In this pilot proof-of-concept study we quantify and compare DNA methylation in blood serum of individuals with Parkinson’s Disease relative to matched healthy blood profiles. Even with a small study of only six samples, a high degree of statistical discrimination was achieved based on CpG methylation profiles between groups, with 1008 statistically different CpG sites (p <0.0025, after false discovery rate correction). The future need for precision diagnostics now requires more tools for exploring epigenetic processes that may be linked to cellular dysfunction and subsequent disease progression. The paper, "Epigenetic DNA Methylation Profiling with MSRE: A Quantitative NGS Approach Using a Parkinson's Disease Test Case", is an open access publication and available at Frontiers in Genetics 2016:00191.Read More
Genome Profiling, LLC today announced that data from the company’s methylation quantification technology and its successful result in stratifying pre-treatment responders vs non-responders to Vidaza treated High-Risk MDS and AML Patients, will be presented at the 2016 American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, December 3-6, 2016. The work was conducted as a collaborative study with the H. Lee Moffitt Cancer Center, Tampa, FL.Read More
Genome Profiling, LLC (GenPro) was recently selected to participate and collaborate with four leading precision medicine technology providers and prominent experts from medical centers and universities across the country in the Undiagnosed Disease (UnDx) Consortium to produce new diagnostic and treatment hypotheses for an initial set of six patients struggling with undiagnosed diseases. GenPro will be providing the epigenetic profiling expertise within the multidisciplinary precision medicine approach that, combined with gene sequencing provided by Illumina, is tasked to elucidate new insights into causes and remedies for these difficult medical cases.Read More
Genome Profiling, LLC (GenPro), a molecular information company focused on discovering novel epigenetic biomarkers and translating them into new clinically valuable precision assays, and new insights into pathways, MOA’s, and potential therapeutic targets, announced that Adam Marsh, Ph. D., Chief Science Officer and Co-Founder, will present recent data illuminating the efficacy of epigenetic biomarker discovery and the game-changing potential they can deliver across many diseases and applications during the Eighth Annual Next Generation Dx Summit held in Washington DC on August 22-26 at 12:30 pm in the “Predictive Cancer Biomarkers” symposia.Read More
Adam Marsh, Ph. D, Chief Science Officer and Co-Founder of Genome Profiling, LLC, will present novel data demonstrating the potential power of epigenetic biomarkers to deliver new clinical value for Companion Diagnostics Applications during The Biomarker Conference, at the Fourpoints by Sheraton Conference Center in San Diego on February 18 – 19, 2016 at 10:30 am in the “Novel Technologies and Approaches” session.Read More