Research-grade to regulatory-grade · GCP · CLIA/CAP · FDA
Bring us your research-grade assay. We optimize it for real-world specimens and validate it to the standard your intended use requires: GCP and GCLP for clinical trials, CLIA/CAP for patient testing, or FDA for a cleared or approved IVD.
Research to regulated
Many of the assays we validate began in an academic lab, a biotech discovery group, or as a research-use-only kit. Moving into a regulated setting means showing the assay performs on real patient specimens, across operators, reagent lots, instruments and days, with documentation an inspector or FDA reviewer will accept.
ResearchDx does that work end to end, in our CLIA-certified, CAP-accredited and ISO 13485:2016-certified laboratory.
300+
new assays validated since 2015
15+ years
of assay development and validation experience
FDA 510(k)
clearance for a test performed in our laboratory
Our process
We review your protocol, data, reagents and intended use, and run a gap analysis against the standard you need to meet.
We bring the assay into our laboratory, reproduce your results, and lock down reagents, controls and procedures.
Where performance falls short, we tune extraction, input, chemistry, controls, cutoffs and analysis so the assay is robust on your intended specimens.
We write the validation plan with predefined acceptance criteria, execute it, and analyze the results statistically.
You receive a validation report and SOPs. We run the assay in our laboratory, transfer it to yours, or carry the data into a regulatory submission.
An assay validated for a clinical trial today may need CLIA validation tomorrow and an FDA submission after that. We design each validation so the data carry forward to the next stage.
GCP · CLIA/CAP · FDA
Each standard asks something different of your assay. We design the validation around how your results will be used.
GCP · GCLP
Used for
Clinical trial endpoints, patient selection and exploratory biomarkers
What we validate
Fit-for-purpose validation, with testing under GCP and GCLP: controlled sample chain of custody, audit trails and audit-ready data.
CLIA · CAP
Used for
Laboratory-developed tests reported to physicians, from our laboratory or yours
What we validate
Accuracy, precision, analytical sensitivity and specificity, interfering substances, reportable range and reference intervals, as CLIA requires (42 CFR 493.1253), plus CAP checklist and New York State requirements where they apply.
FDA
Used for
IVDs and companion diagnostics, including site-specific submissions for tests run in a single laboratory
What we validate
Design controls under ISO 13485, analytical validation following CLSI guidelines, clinical performance studies and submission-ready reports.
Performance characteristics
We match the study design to your intended use and the standard you are validating to. A typical validation addresses each of the characteristics below.
Need an independent comparator to establish accuracy? Our orthogonal validation studies compare your assay with an independently validated method.
Accuracy and method comparison
Precision: repeatability and reproducibility
LoB, LoD and LoQ
Linearity and reportable range
Interference and cross-reactivity
Specimen stability and pre-analytics
Cutoffs and reference intervals
Lot, instrument and operator variability
Carryover and contamination
Assays and technologies
We have validated assays across a wide range of technologies, analytes and specimen types, and we regularly onboard new platforms for our clients.
Targeted and custom panels, RNA-Seq, methylation and cfDNA/ctDNA liquid biopsy on Illumina platforms.
Gene expression, copy number, genotyping, methylation, rare mutations, viral load and vector copy number.
Multiplex immunophenotyping, receptor occupancy and immune monitoring panels.
Biomarker quantitation, pharmacokinetics, anti-drug antibodies and cytokines.
Targeted quantitation of small molecules, metabolites, amino acids and peptides.
FISH, anatomic pathology and EXO-NET® extracellular vesicle isolation.
Whole blood
Plasma
Serum
Tissue, including FFPE
Urine
Saliva
Buccal swabs
Cell culture
Send us your protocol and intended use, and we’ll recommend a validation path and timeline.