ResearchDx was founded on the core principles and expertise that help biopharmaceutical companies accelerate, develop, and manufacture their companion diagnostic products. As the premier Contract Diagnostics Organization, ResearchDx has established integrated, turn-key, flexible services that are focused on our customer’s objectives. We manage the entire diagnostic development process – from initial assay concept and discovery all the way through clinical research to regulatory approval. At ResearchDx, we believe in bringing personalized medicine to the next level.
Strong Scientific Support: Each project is carefully evaluated and designed by experienced PhD-level scientists, Doctors and Pathologists. Our design and implementation teams are focused specialists, and all employees participate in our extensive ResearchDx training and competency programs.
Technology Independence: 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. We are free to choose the most appropriate technology for your project.
Accessibility: All projects have a dedicated project manager. We support and encourage regular client updates, and our customers are always welcome to all “Raw” data.
Fast Turnaround: ResearchDx specializes in rapid assay development; often cutting our competitors expected development times in half, without compromising quality or compliance.
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). We adhere to the highest standard in quality management system\and all projects undergo independent quality review.
Broad Range of Development Capabilities: Our development capabilities include a variety of approaches including IHC, Flow Cytometry, Sanger sequencing, quantitative PCR, Microarray, and Next-Gen sequencing technologies.