Analytical accuracy · Concordance · Platform validation
Studies that compare your assay with an independently validated method, designed and executed to meet analytical validation requirements for regulatory filings.
Independent comparator methods
As a diagnostic-focused CRO, our team designs and executes studies that compare an assay with an independently validated orthogonal method, for analytical accuracy, concordance, and platform validation.
We offer externally validated solutions across technology types, and our clients include many of the biggest names in diagnostics.
Validated NGS panels
Sanger sequencing
qPCR
ddPCR
ELISA
Flow cytometry
Any commercial assay, reagent, or kit
What we deliver
Select the comparator, sample size, and acceptance criteria to fit your regulatory requirements.
Source representative samples across the variants, levels, and specimen types you claim.
Run the comparator method in our CLIA-certified, CAP-accredited laboratory, under protocol.
Calculate agreement, precision, and confidence intervals, and investigate discordant results.
Deliver a study report ready for your filing, with a gap analysis against regulatory requirements.
Tell us about your assay and the claims you plan to make. We will recommend a comparator and study design.
Reporting results
When the comparator is not a reference standard, FDA recommends reporting agreement between the two methods rather than sensitivity and specificity, with confidence intervals.
Choosing the comparator and planning how discordant results will be resolved before the study starts keeps the analysis defensible.
Source: FDA, Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests (2007).
Positive percent agreement (PPA)
Of the samples positive by the comparator, the share also positive by your assay
Negative percent agreement (NPA)
Of the samples negative by the comparator, the share also negative by your assay
Overall percent agreement (OPA)
The share of all samples on which the two methods agree
Product focus: PMA & 510(k)
We have performed hundreds of studies for our clients, including dozens using orthogonal comparator methods in support of IVD submissions.
Diagnostic equipment studies with comparison to an orthogonal device.
Diagnostic assay studies with comparison to an orthogonal assay.
Custom-developed comparator assays for unique and bespoke applications.
Product launch validation and comparative studies for marketing claims.
Tell us about your assay, your comparator options, and your submission timeline.