About ResearchDx
Since 2008, ResearchDx has brought every part of IVD and companion diagnostic development under one roof, from assay design through regulatory approval and commercial testing.
Our story
Philip D. Cotter, PhD, and Mathew W. Moore, PhD, founded ResearchDx in 2008 as the first CDO: a diagnostic-focused CRO that integrates and manages all IVD development expertise and services within a single organization.
The decision was driven by the accelerating demands of personalized medicine and the need for a more straightforward path to aligned development and regulatory approval of a therapeutic and its companion diagnostic.
Founded
2008, Irvine, California
Model
Contract diagnostics organization (CDO)
Clinical laboratory
PacificDx: CLIA certified, CAP accredited
Manufacturing
Custom Diagnostics: ISO 13485 and GMP compliant
Why a CDO
Pharmaceutical companies have well-established pathways for drug development, but none existed for co-developing FDA-approved companion diagnostics. Biopharma teams were left with two imperfect options.
Option 1
Outsourcing to multiple vendors means managing a complex process that is neither flexible nor dynamic.
Option 2
Development is limited to that company's existing technology, product lines and platforms, which may not suit the companion diagnostic or the labs that will run it.
The ResearchDx model
A single organization without competing interests, free to choose the best emerging technology and to adapt as your priorities and schedules change.
ResearchDx today
We design, manage and coordinate every aspect of diagnostic development, from concept through regulatory approval, with independent and unbiased guidance based on your goals.
Development and consulting
Program management, assay development, clinical and regulatory consulting for IVDs and companion diagnostics.
Clinical laboratory
Our CLIA certified, CAP accredited laboratory for clinical trial testing, LDT development and commercial testing.
Manufacturing
ISO 13485 and GMP compliant manufacturing for kits and reagents, from RUO through clinical and commercial supply.
Explore the company
Sequencing, PCR, cell, tissue and immunoassay technologies we support.
Tell us where you are today. We will help map the fastest path from concept to approval.