Verification Studies of IntelligentMDx's Proprietary Molecular Diagnostic Assay Process Have Been...( CAMBRIDGE Mass. and COLUMBUS Ohio Jan...),Health

CAMBRIDGE, Mass. and COLUMBUS, Ohio, Jan. 8 /PRNewswire/ --IntelligentMDx a developer and manufacturer of proprietary nucleic acid assays, today announced that verification studies of the IntelligentMDx BK Viral Quantitative Assay are complete.

Under the verification protocol the Limit of Detection, linearity, specificity and reproducibility and robustness of the BK Viral Quantitative Assay were determined. The data obtain 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 that 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 that was tested having an R-squared value is 0.99; this calculates to an amplification efficiency of 94.5%. In addition the specificity (false negative rate) for the assay was shown to be 100% for the limited number of true negatives assessed. Precision and robustness 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.

About IntelligentMDx

IntelligentMDx's mission is to make FDA approved diagnostic kits. To guarantee quality for customers and partners we design, develop and manufacture tests under FDA Quality System Regulations and ISO 13485:2003 guidelines. These tests have been, and will be, designed to run on a broad range of molecular systems for c
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