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Last updated on April 16, 2014 at 17:34 EDT

Latest IMDx Stories

2014-01-29 16:28:51

WALTHAM, Mass., Jan. 29, 2014 /PRNewswire/ -- IMDx announced today that the artus C. difficile QS-RGQ Kit has received CE-marking for use with QIAsymphony SP/AS and Rotor-Gene Q instruments. This is the first of a series of assays designed, developed, and manufactured by IMDx for QIAGEN under a multi-year development and license agreement. Concurrently in December 2013, a Premarket Notification 510(k) submission for the test was submitted to FDA for review. (Logo:...

2013-11-12 12:28:42

WALTHAM, Mass., Nov. 12, 2013 /PRNewswire/ -- IntelligentMDx announced today that it has received FDA clearance for the IMDx C. difficile for Abbott m2000 assay which detects nucleic acids encoding the toxin A gene and toxin B gene sequences of toxigenic strains of Clostridium difficile in human liquid or soft stool specimens collected from patients suspected of having Clostridium difficile associated disease. This is the third test from IMDx to receive FDA clearance within three...

2013-09-10 16:25:46

CAMBRIDGE, Mass., Sept. 10, 2013 /PRNewswire/ -- IntelligentMDx announced today that the U.S. Food and Drug Administration (FDA) has cleared its automated molecular diagnostic test that detects influenza A, influenza B, and Respiratory Syncytial Virus (RSV) directly from nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This is the second test from IMDx's portfolio of molecular diagnostic products to be cleared by the FDA for use on Abbott's fully...

2013-07-29 16:26:01

CAMBRIDGE, Mass., July 29, 2013 /PRNewswire/ -- IntelligentMDx (privately held) announced today that the U.S. Food and Drug Administration (FDA) has cleared its automated molecular diagnostic test that detects the presence of vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE). This is one of the tests in IMDx's portfolio of infectious disease products to be cleared by the FDA for use on Abbott's fully automated m2000 platform. VRE are bacteria...

2013-01-07 16:25:35

CAMBRIDGE, Mass., Jan. 7, 2013 /PRNewswire/ -- IMDx (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. (Logo: http://photos.prnewswire.com/prnh/20120306/NE63745LOGO ) The...

2012-12-19 16:23:32

CAMBRIDGE, Mass., Dec. 19, 2012 /PRNewswire -- IntelligentMDx (IMDx) is pleased to announce that Maurice Exner, Ph.D., has joined IMDx as Vice President of Research and Development. (Logo: http://photos.prnewswire.com/prnh/20120306/NE63745LOGO ) Formerly serving as Vice President of R&D at Focus Diagnostics, a wholly owned subsidiary of Quest Diagnostics Incorporated, Dr. Exner brings over a decade of experience in IVD product development to IMDx. While at Focus, Dr. Exner played an...

2012-07-19 10:23:04

CAMBRIDGE, Mass., July 19, 2012 /PRNewswire/ -- IntelligentMDx (IMDx) announced today that it has obtained CE-marking for its fourth automated, high-throughput molecular test designed and developed for the Abbott m2000 System. The IMDx HSV-1/2 for Abbott m2000 detects Herpes Simplex Virus (HSV) viral DNA and differentiates HSV-1 and HSV-2 in male and female genital or oral lesions and cerebral spinal fluid (CSF). (Logo: http://photos.prnewswire.com/prnh/20120306/NE63745LOGO ) HSV is the...

2012-05-15 06:29:17

CAMBRIDGE, Mass., May 15, 2012 /PRNewswire/ -- IntelligentMDx (IMDx) announced today that it has obtained CE-marking for a new automated, high-throughput, qualitative in vitro diagnostic test designed for the rapid detection of Group B Streptococcus (GBS) for use in screening pregnant women and those in labor who may be infected with the pathogen. GBS is responsible for life-threatening bacterial infections in newborns, including sepsis, meningitis, and pneumonia. The IMDx(TM) GBS for Abbott...

2011-09-21 09:22:00

CAMBRIDGE, Mass., Sept. 21, 2011 /PRNewswire/ -- IntelligentMDx (IMDx) announced today that it has received CE-Mark for its second automated molecular test for the Abbott FDA cleared m2000 instrument. The IMDx(TM) VanR for Abbott m2000(TM) test accurately detects and distinguishes the vanA and vanB genes most commonly found in vancomycin-resistant enterococci (VRE) in specimens from patients at risk for colonization or infection. Detection of both the vanA and vanB genes allows for...

2010-03-24 06:33:00

CAMBRIDGE, Mass., March 24 /PRNewswire/ -- IMDx announced today that its IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay has been granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The test, which is authorized for use on multiple instrument platforms (the Applied Biosystems 7500, the 7500 FAST Real-Time PCR Systems, and the 7500 Fast Dx Real-Time PCR Instrument) by CLIA High Complexity Laboratories to detect and differentiate 2009 Influenza A...