Partner with a leader in genomic medicine
With over a decade of experience in biomarker assay testing, Geneuity has the expertise to fulfill your outsourced specialty testing needs.
Geneuity delivers standardized results bringing together expertise in oncology, hematopathology, and clinical research services. 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
- Outsourced testing for Phase I, II and III
- Anatomic Pathology
- Molecular Diagnostics
- Flow Cytometry
- Cytogenetics
- Fluorescence in situ Hybridization
- Protocol consultation
- Patient selection screening
FULLY QUALIFIED, ACCREDITED, AND COMPLIANT
Geneuity is compliant with all applicable FDA regulations, ensuring compliance to SOP’s 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 provide 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.
- 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.
Operating under a 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’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.
