Biomarker Development and BioMarker Screening

 

ResearchDx supports biomarker discovery, screening procedures, and validation. We provide complete solutions from initial assay design to clinical assay development.

Experimental Design

ResearchDx offers an individualized approach to experimental design. Unlike our competitors, ResearchDx is not an instrument or reagent manufacturer, and we are not bound to promote any single platform.  Instead, our scientific team are free to use a “Fit for Purpose” approach utilizing any commercially available technology. Please talk to us about the best platform for your Biomarker discovery needs.

A small selection of platforms and technologies we have used to develop assays include:

QIAgenpromegaAgilentillumina CSProiontorrentApplied Biosystemsbiocare-medical-squarelogo-1399057016908Leica BiosystemsLogo_Menarini_Silicon_Biosystems_300Abbott_logologo_metasystemsVentana

 

Biomarker Screening:

ResearchDx offers a wide array of DNA, RNA, and protein based approaches. We maintain multiple technology platforms in-house, including:

  • Cytogenetics: Somatic and germline
  • Immunophenotyping including Flow cytometry
  • ELISA design, devlopment, and screening
  • Cytokine analysis
  • PCR and Q-PCR based Molecular diagnostics
  • FISH: Commercial and Custom probes available.
  • Microarray characterization: Affymetrix and Agilent arrays.
  • Gene sequence analysis
  • Gene expression analysis
  • Next-Gen Sequencing: Custom and commercial panels, exome and genome analysis. Analysis from fixed tissues and difficult specimens is a specialty.

Biomarker Candidate Validation

ResearchDx has extensive expertise in “Fit For Purpose” Validations. We can develop, validate, and perform assays to GXP, CLIA, and FDA regulatory standards, and help with submitting a 510(k) or PMA to the FDA. Please talk to us about your assay validation needs.

Translation to Clinical Applications

ResearchDx offers multiple pathways for the commercialization of your Biomarker. Pathways can include:

  • In-house developed assays customized for your application and performed exclusively in our laboratory for your projects.
  • In-house developed custom kits , built at ResearchDx and shipped anywhere in the world to enable third party use.
  • Development and validation of a Laboratory Developed Test (LDT assay) performed at ResearchDx.
  • Development of in vitro diagnostic devices (IVD’s), and regulatory approval for full commercialization and sale in the US and world-wide market.