Geneuity Clinical Research Services and Molecular Pathology Laboratory Network, Inc. have served the clinical and research community since 1989. A leader in the integration of molecular diagnostics with pathology serving drug discovery and medical device clinical studies. We provide a clinical, scientific and operational consultative approach to protocol review, biomarker selection and device validation.
Geneuity Clinical Research Services is a provider of outsourced specialty laboratory testing services for drug discovery serving clinical research organizations, central laboratories, pharmaceutical, biotechnology, and medical device industries.
Geneuity's expertise and experience as a CLIA certified high complexity laboratory, accredited by College of American Pathologists (CAP) and working within a GCLP environment delivers quality operations, data integrity and expert protocol collaboration. We specialize in the integration of molecular anatomic pathology as well as assay and companion diagnostic development and validation. Board certified professionals in molecular, cytogenetic and hematopathology are available in house to assist in the development and review of study protocols and provide technical and interpretive expertise and consultation of results.
Geneuity, a private company, is able to integrate with your development team providing personalized services for studies of a few samples to those involving thousands of specimens on a global scale. We employ the latest molecular and cellular technologies and bioinformatics providing you with timely actionable data to make informed decisions. We offer a clinical, scientific and operational consultative approach to protocol review, biomarker selection or assay validation.
Phase I / II / III
Medical Device IVD submission - Diagnostic assays
Geneuity offers advanced clinical research services focused on improving patient health. Board certified professionals in molecular diagnostics, cytogenetics and hematopathology 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. Geneuity delivers standardized results bringing together expertise in oncology, hematopathology, clinical research and clinical services providing you with solid clinical trial evidence.
Therapeutic Experience and Clinical Trial Testing
Partnering with a leader in genomic medicine with more than 25 years of experience in molecular diagnostics and more than 10 years in research services brings expert knowledge and application in molecular diagnostic assay development, clinical testing and bioinformatics. Geneuity delivers timely results for an expedient regulatory submission ensuring minimal trial cost and better outcomes.
Experience in Molecular Diagnostics as a Clinical Reference laboratory for more than 25 years brings expertise to conducting medical diagnostic validation testing. Access to sample types, bioinformatics and pathology consultation ensures timely results and shorter time to regulatory submission. We serve Oncologists, Pathologists and Women’s Health Physicians with a broad menu of specialty pathology and molecular testing. We are experienced in data collection for IVD/PMA submission as well as data presentations for FDA advisory committees.
Conducting assays in:
Contact our clinical affairs office to request a consultation for your next validation study.