CAMBRIDGE, Mass. and COLUMBUS, Ohio, Oct. 28 /PRNewswire/ -- IntelligentMDx a developer and manufacturer of proprietary nucleic acid assays, today announced that it is working with the Battelle Eastern Science and Technology (BEST) Center to conduct assay performance verification studies of its nucleic acid-based diagnostic or ‘smart’ molecular diagnostic assays.
Under terms of the agreement Battelle will perform various testing of IntelligentMDx’s Quantitative BK Virus (BKV) Real-Time PCR Assay to identify its performance characteristics. Financial terms of the agreement were not disclosed. BKV has recently emerged as an important pathogen in nephropathy in kidney transplant patients and hemorrhagic cystitis in human stem cell transplant patients. The IntelligentMDx Quantitative BK Virus Real-Time PCR Assay can be utilized to track the course of infection and monitor response to treatment.
The biggest hurdle for a nucleic acid testing is that current reagent design methods do not specifically address the core set of challenge affecting reagent performance -- such as genetic diversity and other key performance metrics. IntelligentMDx has a proprietary process to manage the design, development and manufacturing of pathogen assays that are platform agnostic and adaptable to all nucleic acid detection methodologies. The IntelligentMDx process allows for rapid time to market.
About IntelligentMDx
IntelligentMDx(TM) develops and manufactures tests, under regulatory compliance, for a broad range of molecular based systems for use in clinical molecular diagnostics, drug development and applied science applications. Our mission is to rapidly translate the needs of the clinician, patient and partners into very specific, highly sensitive, robust clinically impactful tests, thus enabling caregivers worldwide to provide care with certainty(SM).
IntelligentMDx’s competitive advantage incorporates intelligent software with assay development and manufacturing expertise within a Quality System compliant with both ISO and FDA current regulations. Our uniquely integrated modular test development process provides clinically impactful and novel nucleic-acid testing solutions including Real-Time PCR assays. The company is working to use its proprietary “symptom-based diagnostics” approach for disease detection. Our goal is to provide the end users with “smart” tests that detect several related diseases at once -- more quickly and more economically than current standard individual tests. The quality and breadth of our product candidate pipeline, platform-agnostic approach, scientific team and strategic collaborations and partnerships is enabling us to become a fully integrated molecular diagnostics company.
About Battelle
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 $200 million annually in health and life sciences-research contributing to advances in medical devices, pharmaceuticals, public health, and next-generation diagnostics and therapeutics.
Battelle is the world’s largest non-profit independent research and development organization, providing innovative solutions to the world’s most pressing needs through its four global businesses: Laboratory Management, National Security, Energy Technology, and Health and Life Sciences. It advances scientific discovery and application by conducting $4 billion in global R&D annually through contract research, laboratory management and technology commercialization. Headquartered in Columbus, Ohio, Battelle oversees 20,400 employees in more than 120 locations worldwide, including six national laboratories which Battelle manages or co-manages for the U.S. Department of Energy.
Statements in this release, including 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.
