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IntelligentMDx Announces CE-Marking of a Test for Detection and Differentiation of Influenza A, Influenza B, and Respiratory Syncytial Virus


4/12/2013 8:40:32 AM

April 12, 2013, Cambridge, MA – IntelligentMDx (IMDx) announced today that it has obtained CE-marking for a multiplexed, real-time PCR test for detection and differentiation of Influenza A, Influenza B, and Respiratory Syncytial Virus. This test is the fifth in a portfolio of CE-marked infectious disease tests designed, developed, and manufactured by IMDx for use on Abbott’s leading m2000 RealTime System.

The IMDx Flu A/B and RSV for Abbott m2000 assay offers an automated method for accurately testing up to 94 patient samples per run. Minimal hands-on time is required as results are obtained directly from an upper respiratory tract specimen (nasopharyngeal swab or nasal swab) taken from a symptomatic patient. The IMDx Flu A/B and RSV for Abbott m2000 assay is capable of detecting multiple Flu A/B and RSV strains, including recently emerging H3N2 variant strains.

“Rapid diagnosis of Influenza A/B and RSV is essential to help control the spread of respiratory infections,” says Dr. Alice Jacobs Nesselrodt, Chairman and CEO of IMDx. “The multiplexing capability and flexible throughput capacity of the IMDx Flu A/B and RSV for Abbott m2000 make it a desirable option for testing large numbers of symptomatic patients.”

Under a multi-year distribution agreement with Abbott, IMDx has designed, developed, and manufactured a CE-marked real-time PCR test menu for use on the Abbott m2000 system including toxigenic C. difficile, vancomycin resistant Enterococci (vanA/vanB), Group B Streptococcus, and Herpes Simplex Viruses 1 and 2.

This IMDx Flu A/B and RSV for Abbott m2000 is CE-marked and not available for sale in the U.S. or Canada.

About IMDx

Based in Cambridge, MA, IMDx (www.IntelligentMDx.com) is an innovator of unique proprietary molecular tests equipped with features and benefits to port onto nearly any molecular testing system. IMDx’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 IMDx facilities are ISO 13485:2003 certified and all of the IMDx products are developed and manufactured within a regulatory compliant (FDA QSR, CE-IVDD and cGMP) environment.

Renda Hawwa, Ph.D.

Business Development Analyst

IntelligentMDx

19 Blackstone Street

Cambridge, MA 02139

Phone: (617) 871-6405

Fax: 617-871-6399

Email: rhawwa@intelligentmdx.com

Visit us at www.intelligentMDx.com



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