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Biopharma Services

Biopharma Services

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.

Key Services Include:

  • Access to pathology resources
  • Protocol consulting
  • Biomarker selection / consultation
  • Biomarker assay development
  • Companion diagnostic selection/validation
  • Clinical study proof of concept
  • Platform and assay performance

Phase I / II / III

  • Specialty assay laboratory support
  • Patient selection screening
  • Bioinformatics
  • Biorepository

Medical Device IVD submission - Diagnostic assays

  • Support data collection studies for 510K/PMA submission
  • Present findings to FDA advisory committee on sponsors behalf

Experience Geneuity Clinical Trial Study Support

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 Geneuity Diagnostic and Medical Device Validation

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:

  • Molecular and Anatomic Pathology
  • Quantitative PCR
  • Gene sequencing
  • 5 to 10 color flow cytometry
  • Constitutional and Oncology cytogenetics with karyotype analysis
  • Fluorescence in-situ hybridization
  • Immunohistochemistry and special stains
  • Chromogenic In-situ hybridization

Contact our clinical affairs office to request a consultation for your next validation study.

Links

Geneuity CRS