Biomarker Discovery and Validation ResearchDX
Biomarker Discovery and Validation ResearchDX
Biomarker Discovery and Validation ResearchDX
1
Diagnostic Development for Precision Medicine

We Build. We Validate. We Deliver.

ResearchDx offers expertise as an integrated start-to-finish partner for Diagnostic Development.
From NGS, RT qPCR, ddPCR to ELISA, Flow and IHC, we bring you the BEST solution to fit your needs.

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2
Regulatory Guidance

Clear Strategic Guidance

ResearchDx supports all types of regulatory submissions.
From CLIA implementation, IDE, 510(k), De Novo, to a single site or Full PMA and BIMO.

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3
Assay Comparison

Identify the BEST Solution

From Orthogonal method validation, Multi-site Reproducibility, HEAD-TO-HEAD comparison with
the gold standard, to studies designed to highlight technology/method advantages.

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We Design, Validate and Commercialize LDT and IVD Diagnostics

Biomarker Discovery Biomarker Discovery
Assay Development Assay Development
Validate in Clinical Trials Analytical & Clincal Validation
FDA Regulatory Filing / Approval Regulatory Submission
GMP Manufacture Final IVD Kit Kit Manufacture
CompanionDX to Market Clinical Testing
identify and finalize Biomarker Discovery
Assay Verification Assay Development
Analytical & Clincal Validation Analytical & Clincal Validation
FDA Submission Regulatory Submission
Kit Manufacture Kit Manufacture
Clinical Testing Clinical Testing
 

We Are With You Every Step of the Way

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