IVD & companion diagnostic development
Your complete resource for in vitro diagnostic (IVD) and companion diagnostic (CDx) development — one integrated partner from assay design to FDA approval.
A Contract Diagnostic Organization
Navigating the path to an FDA-approved companion diagnostic requires a partner with the expertise, experience, and resources to know the way. As a Contract Diagnostic Organization (CDO), ResearchDx provides all of that within one integrated organization — instead of coordinating specialists across several vendors.
By synchronizing IVD and biopharma development activities, a single start-to-finish partner simplifies and speeds the work to complete your companion diagnostic at the right time.
Why a CDO
Your dedicated project manager guides every phase of the project, with the flexibility to adapt as your needs and priorities change.
As an independent laboratory with no ties to instrument manufacturers, we evaluate and validate the technology best suited to your diagnostic and help you choose the right commercial strategy.
Our quality system meets FDA’s Quality Management System Regulation (21 CFR Part 820) and ISO 13485. Assays undergo analytical and clinical validation to CLIA, CAP, and FDA requirements, and every project receives an independent quality review.
Scientific and medical expertise across diagnostics, backed by a fully accredited and licensed clinical laboratory for development, clinical, and esoteric testing.
Regulation of laboratory tests
US law offers two routes to bring a diagnostic test to patients. The right one depends on where the test will be performed and how you plan to commercialize it.
Offered by
A single CLIA-certified laboratory that designs and performs the test
Oversight
CMS under CLIA, plus accreditors such as CAP and some states, such as New York
Where it runs
Only in the developing laboratory; samples are sent to it
Evidence
Analytical validation under CLIA; no FDA premarket review
Offered by
A manufacturer that distributes the test as a kit or system
Oversight
FDA through 510(k), De Novo, or PMA, and the QMSR
Where it runs
In any qualified laboratory, according to its labeling
Evidence
Analytical and, often, clinical performance data reviewed by FDA
In March 2025 a federal court vacated FDA’s 2024 rule that would have phased in FDA oversight of LDTs, and FDA formally removed the rule in September 2025. LDTs remain under CLIA oversight. Source: AABB, FDA Formally Vacates LDT Final Rule.
Not sure which path fits your test?
Start a discussionOur GxP-compliant, CLIA-licensed, CAP-accredited laboratory, PacificDx, supports your clinical and preclinical testing along the way.