Partner with a leader in genomic medicine with a decade of experience in biomarker assay testing. Geneuity is a provider of specialty laboratory testing services for drug discovery and companion diagnostics; and it is a supporter of small pharma and biotechnology by providing integrated molecular and anatomic pathology testing, innovative solutions and technologies.
Geneuity delivers standardized results bringing together expertise in oncology, hematopathology, clinical research, and clinical services, providing you with solid clinical trial evidence data. Board certified professionals in anatomic pathology, hematopathology, molecular diagnostics, and cytogenetics are available in house to assist in the development and review of study protocols. Our clinical trial research experts are experienced with document requirements, data and report management, specimen handling, and storage concerns associated with complex clinical trials studies.
KEY SERVICES
- Protocol consulting
- Access to pathology resource
- Phase I, II, III specialty laboratory testing
- Biomarker selection / consultation
- Biomarker assay development
- Companion diagnostic selection / validation
FULLY QUALIFIED, ACCREDITED, AND COMPLIANT
Geneuity is compliant with all applicable FDA regulations, ensuring compliance to SOP’s, GDP and GLCP, and is regulated and certified by the Clinical Laboratory Improvement Amendments (CLIA) ACT 1988 for high complexity testing. Geneuity is accredited by the College of American Pathologists (CAP).
- GCLP compliant
- CLIA certified
- CAP accredited
Understanding the specific needs of a clinical trial is the first step to ensuring the most appropriate testing is performed. Geneuity’s expert group of clinical, scientific, and operational personnel provides a consultative approach to protocol review, biomarker selection, or device validation. Timely results can help deliver successful clinical trial outcomes by reducing time to FDA submission, minimizing risks of rejection, and cost of trial.
Timely results for better outcomes – Geneuity CRS solves your protocol dilemma with Biomarker Adaptive Design Support. Drug development success can be achieved by assessment of the goals of phase I and phase II trials in real time using biomarker adaptive trial design: evaluating the mechanisms of anti-tumor activity, identifying surrogate and predictive biomarkers of response, in addition to traditional endpoints of pharmcokinetics, toxicity and clinical efficacy.
Adaptive trial design is a sequential data driven approach enabling real-time learning, reducing costs and risks, streamlining and optimizing the drug development process to deliver personalized treatment, and an approach to combining therapies to overcome or prevent the development of therapeutic resistance.
Biomarker Adaptive Design allows you to recruit the most appropriate target population. Selective or broad based using interim analysis to determine which select population to focus upon. Geneuity’s board certified molecular diagnostic, cytogenetic, and hematopathology experts can identify the right biomarkers for your protocol, including biomarker and companion diagnostic development.
With a decade of experience in clinical and research services, Geneuity is proficient in selecting the right biomarkers for your trial protocol.
Experts in integration of pathology and molecular diagnostics – Geneuity helps solve your biomarker selection decision. Characteristics of a good biomarker assay include:
- Target method and analyte performance
- Specimen availability ideally by non-invasive procedure
- Specificity for targeted marker
- Sensitivity / prediction of clinical utility
- Precision of assay
Choosing the right biomarker requires an in-depth knowledge of the disease process that can only be provided by experienced board certified pathologists and scientists.
- Specimen suitability
- Clinical utility
- Interpretation of results
- Integration of all pathology data
Geneuity’s board certified molecular diagnostic, cytogenetic, and hematopathology experts can identify the right biomarkers for your protocol, including biomarker and companion diagnostic development.
Our project management team will:
- Assist in the development of study protocols to optimize biomarker selection
- Provide personal project management and client services
- Provide logistics for specimen packaging, transport, handling, and storage
- Determine your needs for data reports and result delivery
- Connect you with resources for data and pathology consultation
- Ensure controlled and compliant information archival / delivery with compliant sophisticated data and facility security
Geneuity is certified by the Clinical Laboratory Improvement Amendments (CLIA) ACT 1988 for high complexity testing and accredited by the College of American Pathologists (CAP).
Operating under GCLP compliant environment, Geneuity is able to discover, develop, and validate biomarkers for clinical trials and companion diagnostic development.
Data is managed by 21 CFR Part 11-compliant laboratory information system.
Geneuity CRS data capture, analytics, and reporting capabilities
Geneuity’s sophisticated data and facility security ensure controlled and compliant information archival / delivery. Our custom developed solution is a 21 CFR Part 11-compliant laboratory information platform (INDIGO) with proprietary reporting technology delivering secure access to clean results with options for PDF, JPG, XLS formats and email, fax, or mobile accessible delivery.
INDIGO laboratory informatics system consolidates, analyzes, and visualizes clinical data from multiple testing platforms to provide custom patient case reports, historical values, and flagging of abnormal results.
A successful trial is reliant on the quality and integrity of specimens collected. At Geneuity it starts with the collections containers, transport kit, and paperwork. We use pre-formatted air-bills to simplify shipping.
Geneuity project manager / client service will personally ensure that specimen collection / handling instructions and requisitions are communicated to each site and adequate supplies are provided. Resupplies are typically shipped the day they’re requested.
All packages containing clinical specimens must comply with International Air Transport Association (IATA) Packing Instruction 650. Geneuity can provide an assortment of IATA compliant boxes and packing supplies, and include specimen collection supplies, freezer gel packs, biohazard specimen transport bags, and an assortment of boxes and specimen packing containers.
Sample tracking
- Web access
- Real-time tracking from collection to delivery
- Accessioning and specimen status
Geneuity can provide integrated testing reports within our system or into your reporting system.
