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
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.
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 clinical diagnostics, drug development and applied sciences.
IntelligentMDx's competitive advantage is in the production of superior performing tests with significantly faster time to market than other approaches. Embedded in the approach is an intelligent technology that uses mathematical algorithms to predict test failure and simulate real life conditions such as contamination or genetic mutations, that would impact test functionality. IntelligentMDx's current pipeline includes proprietary nucleic acid (DNA or RNA) tests for Real Time PCR. These tests cover a range of important infectious diseases and are designed to drive the clinical decision making process, maximizing impact on patient care.
Battelle's Global Health and Life Sciences business delivers a comprehensive set of R&D services to solve complex challenges for government health agencies and medical device, biotechnology, and pharmaceutical firms. Including the national laboratories it manages or co-manages, Battelle oversees over
Statements in this release, including but not limited to those that may relate to revenue growth, trends in financial or operational performance, litigation, new product plans and business prospects are forward-looking statements. Actual results might differ materially from these statements due to risks and uncertainties, including the impact of competitive products and pricing, market acceptance of new products, market conditions and enforcement of intellectual property rights. A more detailed description of these risks and other risks applicable to IntelligentMDx are available upon request from IntelligentMDx. IntelligentMDx disclaims any intent or obligation to update these forward-looking statements.