CDx co-development
Co-develop the companion diagnostic alongside your therapy, with biomarker strategy, clinical trial assays, FDA submissions and kit manufacturing from one partner.
The co-development path
Choose the biomarker, specimen type and technology platform that fit the therapy and the market.
Develop and validate the clinical trial assay, and run it for patient selection in our CLIA laboratory.
Assess whether the trial assay needs an IDE, and support the submission when it does.
Bridge the results when the final test differs from the clinical trial assay.
Prepare the PMA or 510(k) for the companion diagnostic, coordinated with the drug filing.
ISO 13485 kit manufacturing and launch, or commercial testing in our laboratory.
Why ResearchDx
A contract diagnostics organization focused on diagnostics, with quality systems in place from day one.
A single point of contact across development, testing, regulatory and manufacturing.
We recommend the technology that fits your biomarker, not one we are tied to.
CLIA, CAP, GLP and ISO 13485 systems applied early, so trial data can support your submission.
Regulatory basis
FDA expects a companion diagnostic to be developed alongside the therapy it is used with, and approved or cleared at the same time. Planning the diagnostic early helps avoid delays to the drug approval.
Our regulatory team prepares Pre-Submissions, IDEs and PMA or 510(k) submissions, and our laboratory and manufacturing teams generate the data behind them.
Tell us about your therapy, biomarker and trial timeline, and we will outline a co-development plan.