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IntelligentMDx BK Viral Quantitative Assay Verification Studies Are Complete

IntelligentMDx, announced that verification studies of the IntelligentMDx BK Viral Quantitative Assay are complete. Under the verification protocol the Limit of Detection, specificity, linearity and reproducibility and robustness of the BK Viral Quantitative Assay were determined. The data obtained agreed with internally generated analytical performance data generated at IntelligentMDx. The data was consistent with data obtained from external clinical data obtained from Washington University which was presented at the 14th Annual Meeting of the Association for Molecular Pathology. The verification studies were performed at Battelle. Based upon the data obtained the assay was shown to have a Limit of Detection of 8 copies of BK target per assay. The assay was linear over the 5 log range which was tested having an R-squared value is 0.99; this calculates to an amplification efficiency of 94.5%. Apart from the specificity (false negative rate) for the assay was shown to be 100% for the limited number of true negatives assessed. Robustness and precision testing showed that the test was highly precise and robust with inconsequential variation observed in day-to-day and tech-to-tech testing. Analysis of the standard quantitative curves for each plate run (n=14) showed an average slope is -3.37 with a 95 percent confidence interval of (-3.47, -3.27) with all R-squared values are above 0.99 with the exception of one plate.