{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"93.6","upperLimit":"98.3","value":"96.70"}]}],"title":"Agreement for V600E"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"78.6","upperLimit":"95.7","value":"90.00"}]}],"title":"Agreement for V600K"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"91.6","upperLimit":"97.0","value":"95.00"}]}],"title":"Agreement for mutation negative"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"92.7","upperLimit":"96.4","value":"94.90"}]}],"title":"Agreement for overall"}],"denoms":[{"counts":[{"groupId":"OG000","value":"734"}],"units":"Participants"}],"description":"Analytical and clinical validation of the companion diagnostic (cDx) assay was performed to determine the extent of agreement between the bioMerieux cDx assay (THxID BRAF Assay) and the Clinical Trial Assay (CTA) to detect BRAF mutations to determine participant eligibility into the study. Skin tissue samples collected at the Screening visit were used for this analysis. Multiple specimen per participant were analyzed.","dispersionType":"95% Confidence Interval","groups":[{"description":"Specimens were tested for V600E mutations to determine trial eligibility with the CTA were retested with the THxID BRAF test. The analytical agreement between the THxID BRAF and the CTA was evaluated for both mutation positive and mutation negative specimens from all sites.","id":"OG000","title":"All Screened Participants"}],"paramType":"NUMBER","populationDescription":"V600E positive participants screened for BREAK-3 study","reportingStatus":"POSTED","timeFrame":"Screening","title":"Agreement Rate for V600E Mutation Validation of the BRAF Mutation Assay","type":"SECONDARY","unitOfMeasure":"Percent agreement"}