Geneuity offers advanced clinical research services focused on improving patient health
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.
Fully qualified, accredited, and compliant
Geneuity is compliant with all applicable FDA regulations, ensuring compliance to SOP’s and GCLP, 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
Testing Services Expertise
Partner with a leader in genomic medicine with a decade of experience in biomarker assay testing. Geneuity – a provider of specialty laboratory testing services for drug discovery and companion diagnostics, serving small pharma and biotechnology by providing integrated molecular and anatomic pathology testing, innovative solutions, and technologies.
Geneuity is the best choice to meet your clinical research needs with expertise in:
- Tumor oncology
- Biomarker selection
- Companion diagnostic validation
Geneuity delivers timely results for an expedient regulatory submission ensuring minimal trial cost and better outcomes. With expertise in:
- Outsourced Testing for Phase I, II and III
- Anatomic Pathology
- Molecular Diagnostics
- Flow Cytometry
- Cytogenetics and Fluorescence in situ Hybridization
- Protocol Consultation
Our Expertise in molecular diagnostics, pathology, informatics, innovative solutions, and technologies ensures Geneuity is the best choice to meet your clinical study testing needs. Turnkey laboratory operations are also available for clinical studies.
The latest molecular and cellular technologies and bioinformatics are employed, to provide timely actionable data for informed decisions. Geneuity will seamlessly integrate with your development team by providing personalized services for studies of a few samples to those involving thousands of specimens for regulatory submission. With expertise in:
- Assay validation for 510K/PMA data collection
- Presentation to FDA advisory committee
- Partner for Companion Diagnostic Development
- Turnkey Laboratory Operations
- Platform and Assay Correlation
- Clinical Interpretive Expertise and Result Consultation