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FDA Clears Meridian illumigene GBS - Analyst Blog

Diagnostic test kits maker Meridian Bioscience ( VIVO ) has won the approval of the U.S. Food and Drug Administration ("FDA") for its new illumigene GBS (Group B streptococcus) test. This is the company's second molecular test in its illumigene platform.

GBS, a bacterial infection, can cause serious illnesses and is associa ted with maternal and neonatal morbidity. It can also affect babies during pregnancies. The U.S. Centers for Disease Control and Prevention ("CDC") has recommended a universal culture-based screening for GBS, to be performed between 35 and 37 weeks of pregnancy.

The illumigene GBS test, which leverages loop-mediated isothermal DNA amplification technology to detect the pathogen in samples, produces results in less than an hour. The test, which is being conducted through a simple procedure (including heat treatment, amplification and detection), allows laboratories to comply with the CDC recommendations.

The company feels that the novel illumigene GBS test will provide hospitals and laboratories a simple, highly sensitive and economical test, helping them in early detection and proper management of GBS.

Meridian specializes in developing diagnostic test kits for serious and infectious diseases. Its diagnostics business faces stro ng competition from Abbott Laboratories ( ABT ), Becton, Dickinson and Company ( BDX ), Thermo Fisher ( TMO ) and Siemens ( SI ).

Meridian, in August 2011, released its outlook for fiscal 2012. The company hopes sales for the year to be boosted by illumigene and Bioline products as well as its foodborne and H. pylori tests.

Meridian is optimistic that sustained adoption of the illumigene platform, growth in core products and opportunities in Europe will help it drive significant growth in sales and earnings in fiscal 2012 and beyond. The company noted that its fiscal 2012 outlook includes full year sales from its C. difficile test illumigene as well as revenues from illumigene GBS.

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MERIDIAN BIOSCI ( VIVO ): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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