ResearchDx

ResearchDx is the leading Contract Diagnostics Organization (CDO) for the biopharmaceutical and diagnostic industries. We provide integrated, turn-key, flexible services that are focused on our customers’ objectives. We manage the entire diagnostic development process – from initial assay concept and discovery through clinical research to regulatory approval. At ResearchDx, we take contract R&D for diagnostics to the next generation.

A Contract Diagnostics Organization (CDO) allows diagnostic, biotechnology and pharmaceutical companies to outsource to a single partner offering integrated services within one organization. ResearchDx combines diagnostics research, a licensed and accredited clinical laboratory, manufacturing, and consulting, in an integrated, technology-independent manner.

ResearchDx can design, manage, and coordinate all aspects in the development of a diagnostic product. Our services include: (1) Assay development, platform evaluation and validation; 2) Management of all levels of regulatory compliance, processes, applications and approvals, including FDA submissions for 510(k) or Premarket Approval (PMA) clearances; 3) CLIA approved and CAP accredited Clinical Laboratory services and 4) GMP manufacturing services.

ResearchDx provides independent and unbiased guidance, expert analysis and seamless integration of all the services you need to develop a diagnostic product including; assay development, clinical laboratory services, clinical trial design and conduct, project management, manufacturing, regulatory guidance and submissions, and consulting. ResearchDx can adapt to meet your complex and constantly evolving needs for diagnostic development. We can build, validate, and perform any assay that your business demands, or alternatively work with competing technology vendors to ensure the best fit for your application.

Your diagnostic development is ResearchDx’s sole focus. We have the experience and dedication to ensure the fastest possible path to commercialization and regulatory approval of the diagnostic product. 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.