We Design. We Validate. We Deliver.
ResearchDx offers expertise as an integrated start-to-finish partner for Diagnostic Development.
From NGS, qPCR, ddPCR to ELISA, Flow and IHC, we bring you the BEST solution to fit your needs.
Biomarker Discovery, Assay Development, Clinical Trial Assays, 510(k), PMA,
CLIA and GLP Testing, Regulatory Submissions and Consulting
Clear Strategic Guidance
ResearchDx supports all types of regulatory submissions.
From Analytic Validation, IDE, 510(k), De Novo, to single site or Full PMA.
ResearchDx offers state-of-the-art custom and molecular assay development, from concept and biomarker discovery, through clinical validation and regulatory approval to final kit manufacturing. We can step in at any stage in the process to support your project needs. The ResearchDx team is highly skilled in all project phases associated with regulated and non-regulated environments in both the United States and abroad, supporting diagnostic development partnerships worldwide. We offer a diverse array of platforms and technologies and can support all development and testing needs, molecular and non-molecular. A list of platforms and technologies we support is found here. Since 2015, we have validated over 300 new assays and performed millions of tests for our clients in the US and internationally.
Meeting complex requirements
Our Pharma and biotech companies are requesting increased complexity and shortened turnaround times for central laboratory services and testing requirements, including disease and drug-specific biomarker assessments and biomarker assay development to determine safety and efficacy of compounds in development. ResearchDx remains committed to continually expanding our capabilities to address these growing demands. Our development team is staffed by dedicated teams of scientists and fully equipped with state-of-the-art technologies and standardized instrumentation. Our R&D support includes expertise in fluid, tissue, cell-based, and molecular assay development for biomarker testing, as well as a range of methodologies to address any specific biomarker and assay development demands of a study.
Summary of Services Offered
Not on our list, explore our custom development services
We have over 15 years of experience in custom assay development, we can confidently handle your custom project.