Clinical & Regulatory Services for Molecular Diagnostics

From FDA clearance to clinical trials and reimbursement, dicentra supports every stage of your diagnostic’s lifecycle.

What are Molecular Diagnostics (MolDX)?

Molecular diagnostics are lab tests that detect specific genes, proteins, or mutations to diagnose and guide treatment. MolDX is a CMS program that reviews these tests to determine if they meet Medicare’s coverage and reimbursement criteria.

Why MolDX Matters

MolDX ensures molecular diagnostic tests are clinically valid and useful. By aligning with MolDX, developers generate the evidence needed to demonstrate that a test improves patient outcomes—guiding timely, accurate diagnosis and treatment decisions.

Full-Service CRO Capabilities

Protocol development and feasibility studies
Site recruitment (outpatient, specialty clinics, lab networks)
In-house clinical monitoring and data management
Post-market and utility studies for payer coverage

Regulatory & Market Access Support

FDA 510(k), De Novo, EUA submissions
LDT-to-IVD transitions
CLIA categorization
CMS/MolDX strategy
Private payer evidence packages

Looking for help with MolDX submissions and CMS reimbursement?

Why Choose dicentra?

Broad experience with infectious disease diagnostics and companion diagnostics
Integrated CRO + regulatory team streamlining execution
Payer-aligned clinical and economic evidence generation
Support across U.S., Canada, and EU regulatory systems

Ready to Advance Your Diagnostic Platform?

Schedule a discovery call to explore how dicentra can support your regulatory or clinical goals.

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