Biomarker discovery and assay development shape the range of services at ResearchDx. Expertise includes developing biomarkers for various applications such as dose selection, patient stratification, and therapeutic response. The company handles... assay development for multiple methodologies, including PCR, qPCR, ddPCR, and ELISA, ensuring compliance with regulatory standards like CLIA and CAP. Custom assay development is a notable service, guiding clients from concept to clinical validation and regulatory submission.
ResearchDx provides integrated solutions for companion diagnostic development, simplifying the complexities of multi-partner outsourcing. The organization offers kit manufacturing compliant with ISO 13485 and GMP standards, catering to diverse project needs. With a focus on clinical testing and contract commercialization, ResearchDx supports laboratories seeking CLIA and ISO-15189 accreditation. Recent advancements include the FDA clearance of the GlutenID Celiac Genetic Health Risk Test, expanding its portfolio of innovative diagnostic tools.
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