analytical validation

analytical validation

The process of determining whether an assay detects the mutation it was designed to detect.
References in periodicals archive ?
As our lab has extensive expertise in working in multi-center studies, we believe that the consortia model is the best approach to perform analytical validation of new assays, and to explore how these assays may assist in the future to help with patient stratification for immuno-therapies.
The tests are commercially available, so it's just a matter of laboratories doing all the analytical validation work and getting permission from their state agencies to run the tests.
Galligan will be responsible for all UK based operations including commercial biomarker discovery, CLIA/FDA compliant analytical validation, downstream clinical testing, manufacturing and shipping of clinical specimen and release of controls and reagents for clinical trials.
Analytical validation involves confirming that the method used for the biomarker measurement is accurate, precise, specific, robust, and stable over time (17, 18, 22-24).
For full analytical validation of a biomarker to be completed for use in Phase II or later, testing needs to occur from preclinical/Phase I exploratory stages.
LPC has already been successfully assessed in two smaller clinical trials and the large prospective multi-centre clinical study with an observation period of five years is set to be unblinded by the year-end, while the analytical validation is anticipated to be completed in the first half of next year.
One significant element of the concept paper was that it separately addressed issues related to analytical validation, clinical validation, and clinical utility.
With those established general guidelines in mind, we describe an approach for analytical validation of clinical sequencing assays.
In brief, one must first validate a method for the detection of a biomarker, analytical validation, before validating the ability of the biomarker to flag the clinical event in question, clinical validation.
His main concepts are data pretreatment to detect outliers of various types and strategies for treating those found; and analytical validation, which assesses results using systematic and extensive comparison.
A secondary purpose is the analytical validation of existing and/or newly developed technologies for their usefulness in cancer detection.