From biomarker to market
Whatever stage your diagnostic is at, ResearchDx brings development, validation, regulatory, testing and manufacturing together under one roof. Bring us in where you need us, or for the whole path.
Our solutions
Each solution can stand alone or connect to the next, so your data, documentation and team carry forward from one stage to the next.
Identify and evaluate biomarkers for dose selection, patient stratification, diagnosis, prognosis and therapeutic response.
Custom assays on NGS, PCR, flow cytometry, immunoassay and LC-MS/MS platforms, built for their intended use.
Take a research-grade assay, optimize it, and validate it to GCP and GCLP, CLIA/CAP or FDA standards.
Prove accuracy against an independently validated comparator method for regulatory filings.
Co-develop a companion diagnostic alongside your therapy, from biomarker selection to PMA.
A complete plan from development to the right regulatory path, reimbursement and market access.
Your own branded, CLIA-certified and CAP-accredited laboratory suite inside our facility.
Clinical trial, LDT and GxP testing, sequencing, cytometry, biorepository and kit manufacturing.
Clinical laboratory, clinical trial, regulatory and diligence consulting from a team that runs its own laboratory.
Why one partner
Diagnostic programs slow down at every handoff between developers, laboratories, regulatory consultants and manufacturers. ResearchDx brings these capabilities into a single, integrated organization.
The team that develops your assay also validates it, runs it in our accredited laboratory, prepares your submissions and manufactures your kits.
CLIA certified
CAP accredited
ISO 13485:2016 certified
FDA registered
Share your program, timeline and goals, and we’ll recommend where to start.