CAMBRIDGE, Mass., Jan. 7, 2013 /PRNewswire/ -- IntelligentMDx (privately held) announced today that it has entered into a multi-year development and license agreement with QIAGEN (NASDAQ: QGEN, Frankfurt Prime Standard: QIA) to design, develop and manufacture several undisclosed CE-marked and FDA cleared diagnostic tests for use on QIAGEN's flagship QIAsymphony RGQ automated platform. Financial terms have not been disclosed.
The undisclosed assays being developed by IntelligentMDx are planned to be incorporated into QIAGEN's growing menu of molecular diagnostic assays and will be distributed by QIAGEN worldwide. QIAGEN has also retained the rights to assume manufacturing of the assays pursuant to volume considerations.
IntelligentMDx's innovative assay development process relies on the use of a proprietary bioinformatics platform, which allows for efficient design of robust and accurate diagnostics that can be formatted for a variety of real-time PCR platforms.
"A key element to improving patient care is ensuring clinical labs have access to the widest range of reliable diagnostic test options for their instrumentation of choice," says Dr. Alice Jacobs Nesselrodt, Chairman & CEO of IntelligentMDx. "We are extremely pleased to have the opportunity to combine the strengths of IntelligentMDx and QIAGEN in order to make new tests available globally to labs utilizing the QIAsymphony RGQ."
QIAsymphony is a novel and flexible laboratory workflow automation system for molecular testing that incorporates all workflow steps from biological sample to result. This new and complete workflow solution is comprised of modules that can be used either as stand-alone systems or combined into the fully integrated QIAsymphony RGQ system. Through this system, QIAGEN provides laboratories with a platform that maximizes their efficiency in the emerging field of molecular diagnostics. QIAGEN is developing a broad range of tests for use on this system. The menu includes infectious disease assays, genetics assays and in particular, companion diagnostics (CDx) that are used to guide the use of medicines in treating patients. QIAGEN markets a menu of more than 20 assays for use on the QIAsymphony system in Europe.
"This collaboration will help us to accelerate the expansion of our test menu for the QIAsymphony RGQ. We are currently developing a range of new tests for use on this platform, expanding beyond the already extensive range of tests covering profiling diagnostics as well as prevention/screening assays for a wide array of diseases. In addition, QIAsymphony is also our core platform for our assays in the area of companion diagnostics to guide treatment decisions," said Dr. Dirk Zimmermann, Vice President, Head of Global Development Molecular Diagnostics at QIAGEN. "We are pleased to be working with IntelligentMDx, which adds to the significant development efforts we are conducting internally and helps us to maximize the value of QIAsymphony RGQ for our customers by giving them the opportunity to consolidate an expanding range of molecular tests on one system."
Based in Cambridge, MA, IntelligentMDx (www.IntelligentMDx.com) is an innovator of unique proprietary molecular tests equipped with features and benefits to port onto nearly any molecular testing system. IntelligentMDx's competitive advantage lies in its extensive bioinformatics capabilities, enabling the production of rapid, low cost high quality products with top performance characteristics to empower clinicians to provide care with greater certainty. Current and future product lines include tests for Infectious Diseases (Healthcare Associated Infections, respiratory diseases, STDs, prenatal testing), oncology and other human genetic targets. The IntelligentMDx facilities are ISO 13485:2003 certified and all of the IntelligentMDx products are developed and manufactured within a regulatory compliant (FDA QSR, CE-IVDD and cGMP) environment.