Biomarker Discovery and Validation ResearchDX
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.

4
FDA Signals Major Shift for LDTs

Choose an Organization with FDA experience for your next LDT

ResearchDx offers complete LDT to IVD conversion services including FDA QMS consulting, GMP/ISO13485 Kit manufacturing, Turn-Key 510(k) and PMA Consulting and Fully IVD compliant LDT Laboratory Development and Testing.

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.

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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