Diagnostic Development

ResearchDx has unparalleled experience in developing custom diagnostic assays for your discovery, pre-clinical, and clinical studies. Our team of molecular and cellular biologists provides custom assay development services to customers worldwide, including diagnostic, biotechnology and pharmaceutical, companies as well as academic researchers. We are experienced in assay development and validation at all stages of the process from concept and discovery through to final validation and can support your assay development needs from any point along the way. Our expert teams are highly skilled in an array of technologies including DNA sequencing (Sanger and Next-Gen technologies), gene expression (Microarray, fluid array technologies Digital and Quantitative PCR), genotyping (SNPs and gross chromosomal abnormalities), flow cytometry and ELISA. Whether your project includes testing one or ten thousand samples, we are equipped with multiple platforms to reliably meet different throughput requirements.

Key Features:

  • Strong Scientific Support: Each project is carefully evaluated and designed by experienced PhD-level scientists, and all projects have a dedicated project manager.
  • Fast Turnaround: ResearchDx specializes in rapid assay development; often cutting our competitors expected development times in half, without compromising quality or compliance.
  • Technology Independence: ResearchDx works for you. We do not sell instruments, nor receive a commission from instrument manufacturers. We remain platform agnostic, continuously evaluating new technology and instrumentation to ensure that our assays exceed all design specifications.
  • Validation and Quality Assurance: Our assays undergo rigorous analytical and clinical validation, exceeding the specific regulatory guidelines set by CLIA/CAP and the FDA (GMP, GLP, GCP).
  • Broad Range of Development Capabilities: Our development capabilities include a variety of approaches including IHC, Flow Cytometry, Sanger sequencing, quantitative RT-PCR, array CGH, and Next-Gen sequencing technologies. We strive to provide the technology options best suited to meet the needs for biomarker detection/quantification.

Pre-Clinical Development

ResearchDx can utilize several screening technologies to power your pre-clinical development program. While we are happy to customize any approach to our client’s needs, popular options for establishing a biological baseline include

  • Whole Genome analysis
  • Transcriptome analysis
  • Flow Cytometry, Multiplex ELIZA and Mass-Spec screening.
  • Multiplex QPCR panels

LDT (Laboratory Developed Test Development)

Regulatory authorities are increasingly requesting that diagnostic studies be conducted under the more stringent CLIA regulations. Through our subsidiary, Pacific Diagnostics, we can design, clinically validate custom assays specific for a clinical study, in less than a third of the time of our competitors, and at under half the cost.

Kit Design and Commercialization:

Through our Custom Diagnostics division, we offer flexible manufacturing to meet your business need. Services include:

  • Reagents: We can manufacture reagents under GMP conditions, and provide certificates of analysis where required. Typically our reagents are used for specific pre-clinical, and clinical diagnostic studies, although our customers have found many other unique and interesting uses.
  • Sample Collection Kits: We can provide a GMP/GLP environment for the manufacture and distribution of your specialized sample collection kit needs.
  • Custom Diagnostic Kits: We can provide a GMP/GLP environment for the manufacture and distribution of your specialized diagnostic assays.
  • Product Manufacturing: Custom Diagnostics can OEM manufacture reagents, kit components, or entire diagnostic assays.