IVD Partner

Geneuity supports data collection studies for FDA submission.

Our Expertise in molecular diagnostics, pathology, informatics, innovative solutions, and technologies ensures Geneuity is the best choice to meet your clinical study testing needs. We can 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. Turnkey laboratory operations are also available for clinical studies.

Geneuity’s expert group of clinical, scientific, and operational personnel provide a consultative approach to device validation.

Our scientific team is able to:

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


We provide custom assay development through the design, optimization, and validation of molecular and cellular assays for individual studies. Our laboratories have a wide range of clinical specimens available for testing of IVD kits and validation of new diagnostic reagents and instruments.


  • 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


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
Biomarker Services

Assay Validation and Support for IVD Submission