Companion Diagnostic Development

We Build. We Validate. We Deliver.

ResearchDx integrates and aligns IVD and biopharma development that simplifies, speeds and ensures delivery of your FDA-approved companion diagnostics on time.

We Are With You Every Step of the Way.

Identify & Finalize Biomarker(s)

Develop & Refine IVD Assay

Validate in Clinical Trials

FDA Regulatory Filing / Approval

GMP Manufacture Final IVD Kit

CompanionDX to Market

We Are With You Every Step of the Way.

Identify & Finalize Biomarker(s)

Develop & Refine IVD Assay

Validate in Clinical Trials

FDA Regulatory Filing / Approval

GMP Manufacture Final IVD Kit

CompanionDX to Market

No Multi-Partner Outsourcing.

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BioPharma Services

Diagnostic resources and expertise to support all phases of FDA drug and companion diagnostic development.

IVD Diagnostics

One-stop shop for IVD diagnostics outsourcing for biopharma, biotechnology, diagnostics companies, clinical laboratories, medical research and physicians.

Clinical Trial Consulting

Full clinical trials program services to support an FDA IVD product filing.

Latest News

Negative Gluten ID Test Results can ‘Rule Out’ Celiac Disease in High Risk Populations

Brief: First degree relatives of individuals with celiac disease are at elevated risk for developing a similarly severe gluten intolerance disorder. However, a quick screening test for the genetic alterations responsible for encoding gluten recognition immune receptors can rule out celiac disease risk in these individuals. Developed by Targeted Genomics, the DNA-based, non-invasive Gluten ID […]

Blood-Based Biomarkers Discriminate IBS from IBD with High Degree of Certainty in Patients with Chronic Diarrhea

Brief: Two blood-based biomarkers, cytolethal distending toxin B (CdtB) and anti-vinculin, have been substantively linked with the occurrence of diarrhea-predominant forms of irritable bowel syndrome (IBS). As a result, an ELISA-based diagnostic test developed by Gemelli Biotech is now able to “rule-in” an IBS diagnosis while “ruling-out” irritable bowel disease (IBD) based on elevated biomarker […]