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Meridian Bioscience Announces illumigene® Group A Streptococcus and illumigene® Group B Streptococcu

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By Business Wirevia The Motley Fool

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Meridian Bioscience Announces illumi gene ® Group A Streptococcus and illumi gene ® Group B Streptococcus Tests Categorized “Moderate Complexity” by FDA

CINCINNATI–(BUSINESS WIRE)– Meridian Bioscience, Inc., Cincinnati, Ohio (NAS: VIVO) today announced the U.S. Food & Drug Administration (FDA) has re-categorized Meridian’s illumigene®Group A Streptococcus andillumigene® Group B Streptococcus tests as “Moderate Complexity” under the Clinical Laboratory Improvement Amendments (CLIA). Moderately complex tests are assays that are considered to be simple and easy to use.

The Moderate Complexity categorization of both of these tests allows the benefits of the illumigene platform to be available to all Moderate Complexity laboratories that are in U.S. hospitals and clinics, empowering them to offer an accurate, rapid, simple molecular test for each of these pathogens.


illumigene Group A Streptococcus is a qualitative molecular test for the detection of Group A Strep pharyngitis. Acute pharyngitis is one of the most frequent illnesses for which pediatricians and other primary care physicians are consulted, with an estimated 15 million visits per year in the United States. Clinical studies show that illumigene Group A Streptococcus increased detection of positives by 53% over traditional culture in symptomatic patients.

Group B Streptococcus (GBS) continues to be a major perinatal pathogen, for both mothers and their infants, and is associated with significant morbidity and mortality. illumigene Group B Streptococcus fully complies with the CDC guidelines for the detection of GBS and clinical studies have shown that broth enrichment, followed by testing with illumigene Group B Streptococcus, increased detection of true positives by 29% over traditional culture, thus allowing for appropriate treatment of mother at time of delivery, ensuring the best outcome for baby.

Jack Kraeutler, Chief Executive Officer, stated, “Due to its simplicity and superior accuracy, our illumigene technology platform enables most clinical labs to perform sophisticated molecular diagnostics without the high costs of capital equipment and ongoing service charges. The Moderate Complexity classification of the illumigene Group A Streptococcus test and the illumigene Group B Streptococcus test, along with illumigeneC. difficile, enables more labs to adopt molecular testing thereby helping to provide better patient outcomes.”

Meridian is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies. Utilizing a variety of methods, these products and diagnostic tests provide accuracy, simplicity and speed in the early diagnosis and …read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

INSERTING and REPLACING University of Texas Health Science Center at Houston Releases News of Succes

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By Business Wirevia The Motley Fool

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INSERTING and REPLACING University of Texas Health Science Center at Houston Releases News of Successful NanoLogix Test

UTHealth researchers say more rapid test for Group B strep successful

HUBBARD, Ohio–(BUSINESS WIRE)– Insert inside the quotation marks in the first graph, first sentence of release: Infectious Diseases in Obstetrics and Gynecology

Please also embed with the URL:  http://www.hindawi.com/journals/idog/2013/367935/

The corrected release reads:

UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON RELEASES NEWS OF SUCCESSFUL NANOLOGIX TEST

UTHealth researchers say more rapid test for Group B strep successful

NanoLogix Inc. (OTC: NNLX), an innovator in the accelerated detection, identification and antibiotic sensitivity determination of live bacteria, announces that final results of a 14 month study done by researchers at UTHSC-Houston have been published in a recent online edition of “Infectious Diseases in Obstetrics and Gynecology.” The results were also presented at the 33rd annual Society of Maternal Fetal Medicine meeting last month in San Francisco. Researchers tested 356 pregnant patients for Group B Strep using NanoLogix BNF tests during the study, with NanoLogix test results obtained in 6.5 hours as opposed to 48 hours with standard tests.

Jonathan Faro, MD, PhD, the chief researcher on the study and assistant professor in the Department of Obstetrics, Gynecology and Reproductive Sciences at The University of Texas Medical School at Houston, part of UTHealth, stated: “We’re very happy at UT to have the recent clinical study on GBS showing positive results with the 6.5 hour test. Even more exciting, however, is that we are now seeing results as fast as 30 minutes. This more rapid test is based on a modification of the 6.5 hour test, and has the potential to allow for antibiotic susceptibility testing in an amount of time that would have previously been considered simply impossible. The studies with GBS have been applied to other bacteria, and we are very pleased to see similar results with gonorrhea, which has been implicated last year as a multi-drug resistant pathogen. We are in the final stages of formalizing the 30 minute test for GBS, and will continue to work on additional applications for this assay.”

The news from UTHealth Houston can be found here: http://www.uthouston.edu/media/story.htm?id=e3142cc6-bc5b-415d-8f17-8243da5eb58d

NanoLogix exhibited at the ASM BioDefense and Emerging Diseases Research Meeting in Washington DC 25-27 February 2013. There was strong interest in the Company’s technologies at the exhibition. Interested parties included Federal agencies, universities, large and small laboratories, NGO‘s, and corporations, with resulting sales begun this week.

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Source: FULL ARTICLE at DailyFinance