GENEUITY PARTNERS WITH PHARMA, BIOTECH, CONTRACT RESEARCH ORGANIZATIONS, AND MEDICAL DEVICE COMPANIES TO DESIGN AND PERFORM BIOMARKER ANALYSIS BASED ON DEVELOPMENT NEEDS.
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.
Contract Research
- Outsourced testing for Phase I, II and III
- Anatomic Pathology
- Molecular Diagnostics
- Flow Cytometry
- Cytogenetics
- Fluorescence in situ Hybridization
- Protocol consultation
- Patient selection screening
Pharma Services
- Protocol consulting
- Access to pathology resource
- Phase I, II, III specialty laboratory testing
- Biomarker selection / consultation
- Biomarker assay development
- Companion diagnostic selection / validation
IVD Partner
- 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
Biomarker Menu
- Anatomic Pathology and Histology
- Flow Cytometry
- Molecular Biology
- Cytogenetics
- Immunoassays
Laboratory Partners
Our partners program offers clinical, research, and business expertise in molecular pathology so you can be ready for changes in healthcare delivery and personalized medicine. Expanding your portfolio can be a daunting task. Our business development coordinator can help you with a complete range of services to support your development process. Our services include:
- Turnkey laboratory operations
- Companion diagnostic validation
- Companion diagnostic reference laboratory commercial partner
- Biomarker assay assessment
- IVD data collection