Working Together to Provide EpiMarker-enabled Solutions That Advance the Promise of Precision Health.
GenPro customer collaborations are enabled by and executed using the EpiMarker Platform - A scalable, proven and proprietary combination of tightly integrated and controlled workflows, chemistry, and machine-learning bioinformatics applied using a disciplined, phased, milestone-based, methodology and GenPro expertise.
Typical collaboration engagements are focused to solve a significant problem or collection of problems by combining GenPro’s capabilities and know how with a Collaboration Partner’s clinical expertise, patient samples and anonymized patient clinical information. This approach is engineered to deliver predictive, timely, repeatable and cost-effective successful outcomes suitable for regulatory scrutiny and development.
Stage 1 for Collaboration Partnerships, regardless of the industry, are common. The goal is to discover and blind-validate a novel blood-based immune-system-derived EpiMarker, translate the EpiMaker into precision assay/clinical test, and CLIA-validate the test for follow-on R&D, clinical, and clinical development steps. Stage 1 Engagements consist of 3 Steps that GenPro manages in a turnkey engagement structure. Step 1 (~10 weeks) is the discovery of the novel EpiMarker and its validation using a blind patient cohort. If the results of this step do not meet the performance goals, the Collaboration Partner can exercise an engagement termination option. If this step is successful, the engagement advances through Step 2 (~16 weeks), EpiMarker translation into a precision panel assay followed by, Step 3 (~8 weeks) CLIA certification of the assay for its intended clinical use. This front-end process is designed to transform aspirations into read-to-use new actionable clinical utility.
Biopharmas hire GenPro to discover novel blood-based immune-system derived EpiMarkers matched to their pipeline therapeutics that can be used to identify responders vs non-responders to their drug(s) and translate the EpiMarker into a simple whole blood test using standard panel assay technology that can be easily used to improve responder patient selection into clinical trials and thereby clinical trial outcomes.
The outcome of the 3-step Stage 1 engagement is a novel EpiMarker-enabled CLIA certified assay/clinical test for R&D, clinical and clinical development use.
During the Stage 2 phase of the collaboration engagement, GenPro leads the transformation of the CLIA test into a regulatory approved test for trial patient selection using either one of its CRO assay execution partners, or one specified by the Biopharma collaboration partner, with Genpro providing results processing and reporting through its cloud platform.
During the Stage 3 phase of the collaboration engagement the biopharma partner has the option to transform the drug-specific patient selection assay into a companion diagnostic for regulatory approval and commercialization alongside the drug. During this stage, GenPro would transfer the assay execution to the biopharma’s preferred CDx partner for whom GenPro would provide results processing and reporting through its cloud platform.
In all cases, biopharma collaboration partnerships are tailored to the biopharma partner’s situation, need, opportunity and preferences, but executed using GenPro’s disciplined methodology with GenPro’s greatest value being provided during Stage 1, then transferred to global CRO and CDx partners of the biopharma.
Molecular Diagnostic Companies
Molecular Diagnostic Companies hire GenPro to discover novel blood-based immune-system derived EpiMarkers to address unserved or poorly served precision medicine opportunities for early disease detection tests, new diagnostics, therapeutic performance monitoring, and for novel CDx/Complementary Dx needs.
Most aspire to expand in an existing market with more and better tests and/or enter new markets. Most aspire to expand into Epigenetic Diagnostics. In each of these scenarios, GenPro is typically hired to rapidly discover novel EpiMarkers and translate them into CLIA approved tests that they can take through their established regulatory approval and commercialization processes. As such Stage 1 collaborations are structured similarly to how they are performed for Biopharmas, as a 3-step engagement: 1.) EpiMarker Discovery & Blind Validation; 2.) Translation of Novel EpiMarker into a panel assay clinical test; and 3.) Obtaining ClIA approval for the clinical test.
Once the test is licensed to the Molecular Diagnostic partner for regulatory approval and commercialization, Stage 2 of the engagement has GenPro supporting the Molecular Diagnostic Partner with results processing and reporting services through its cloud platform. In all cases, biopharma collaboration partnerships are tailored to the biopharma partner’s situation, need, opportunity and preferences, but executed using GenPro’s disciplined methodology.
Clinical Research Institutions
Genome Profiling enters into collaboration partnerships with Clinical Research Institutions when either GenPro or the Clinical Research Institution identifies a big underserved clinical need/opportunity that could be addressed by an EpiMarker-enabled clinical test that the Clinical Research Institute has deep clinical expertise in and adequate patient samples; and for which GenPro capabilities and approach can deliver a successful scientific and commercial solution.
Most are focused to exploit a big unserved or poorly served precision medicine opportunity for early disease detection tests, new diagnostics, therapeutic performance monitoring in any disease area, but the areas of opportunity are not limited. These collaborations could be completely funded by GenPro or the Clinical Research Institution, or involve combined funding. Once decided, the engagement execution process commences with a Stage 1 engagement wherein GenPro rapidly discovers a novel EpiMarker and translates it into a CLIA approved test that is the same process performed for Biopharma and Molecular Diagnostic Companies. Throughout, there are numerous opportunities for institution-led scientific publications and presentations at scientific meetings.
Stage 2 would involve GenPro taking responsibility for the commercialization of the test, either directly, or most likely through a Molecular Diagnostic partner with expertise in the disease area and with the global regulatory approval and marketing infrastructure in place for the most expedient approval and commercialization.
EpiGenetic Profiling Services
Biopharma’s, Molecular Diagnostic and Clinical Research Institutions who seek to explore the potential of GenPro’s capabilities through exploratory or proof-of-concept work-for-hire engagements can do so using GenPro’s EpiGenetic Profiling Services.
These services are provided to support either collaborative pilots as a precursor to a structured solution engagement as described above, and for exploratory research projects that leverage the EpiMarker Platform’s ability to generate high resolution epigenetic profiles AND illuminate novel biological epigenetic insights into genes, mechanisms of action, and pathway data and information. There is no limitation on the disease area or the application. The service-partner would be responsible for providing the appropriate samples (whole blood, tumor, tissue, extracted gDNA, etc.) pursuant to mutual discussion of the goals and scope, and also provide the scientific and clinical expertise, and where appropriate the anonymized patient clinical information. In most cases GenPro will manage the execution of the mutually agreed upon statement of work as a turnkey engagement in conformance with its EpiMarker Platform enabled methodology.