Meridian Bioscience, Inc. (NASDAQ:VIVO) today announced that it has successfully completed beta trials for two new illumigene molecular amplification tests . These assays are designed to specifically detect the DNA of Chlamydia trachomatis and Neisseria gonorrhoeae, respectively , from both swab and urine samples. For the first time, these two new assays will also incorporate Meridian Bioscience’s new nucleic acid preparation device which further simplifies the illumigene test procedure. This novel sample preparation device does not require excessive sample manipulation steps, such as centrifugations or washing, and takes only five minutes to process a clinical specimen. In the beta trial, performance of the new illumigene assays was assessed against two market-leading molecular platforms on a statistically significant cohort of symptomatic patients . The trials were successful and satisfied the design criteria for both assays. Total test time, from specimen to results, for these new illumigene molecular tests was approximately one hour on the illumipro-10™ Integrated Incubator/Reader. It is expected that the clinical trials for regulatory submission will begin later in the second quarter and should be completed later in the third quarter.
Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections are two of the most common sexually transmitted infections worldwide. The WHO (World Health Organization) estimates that 92 million new cases of Chlamydia trachomatis and 62 million new cases of Neisseria gonorrhoeae occur every year. It is estimated that 4 million Americans are infected each year by Chlamydia trachomatis and 1 million infected by Neisseria gonorrhoeae. CDC reported 1.2 million cases of Chlamydia in 2009 in the US, yet data indicate that more than half of sexually active individuals are undiagnosed.
Jack Kraeutler, Chief Executive Officer stated, “Since its market introduction two years ago, the illumigene system has enabled more than 950 acute care laboratories to adopt molecular amplification testing without capital outlays and costly service contracts. Since the launch of illumigene C. difficile, our menu has rapidly expanded to include: a specific claim for testing pediatric patients for C. difficile; illumigene Group B Strep for prenatal testing; and, illumigene Group A Strep which is useful either as a primary test or as a confirmatory test in place of a two-day culture. In addition, the illumigene Mycoplasma pneumonia test has been submitted to the FDA, and we expect to submit our illumigene Pertussis assay to the Agency later in the second fiscal quarter. The illumigene system provides our lab customers with an essential capability for improving the diagnosis of infectious diseases thereby helping to lower the overall costs of healthcare delivery.”
Meridian’s continued growth depends, in part, on its ability to introduce into the marketplace enhancements of existing products or new products that incorporate technological advances, meet customer requirements and respond to products developed by Meridian’s competition. While Meridian has introduced a number of internally developed products, there can be no assurance that it will be successful in the future in introducing such products on a timely basis. Meridian relies on proprietary, patented and licensed technologies, and the Company’s ability to protect its intellectual property rights, as well as the potential for intellectual property litigation, would impact its results. Ongoing consolidations of reference laboratories and formation of multi-hospital alliances may cause adverse changes to pricing and distribution. Recessionary pressures on the economy and the markets in which our customers operate, as well as adverse trends in buying patterns from customers can change expected results. Costs and difficulties in complying with laws and regulations, including those administered by the United States Food and Drug Administration, can result in unanticipated expenses and delays and interruptions to the sale of new and existing products. The international scope of Meridian’s operations, including changes in the relative strength or weakness of the U.S. dollar and general economic conditions in foreign countries, can impact results and make them difficult to predict. One of Meridian’s growth strategies is the acquisition of companies and product lines. There can be no assurance that additional acquisitions will be consummated or that, if consummated, will be successful and the acquired businesses will be successfully integrated into Meridian’s operations. There may be risks that acquisitions may disrupt operations and may pose potential difficulties in employee retention and there may be additional risks with respect to Meridian’s ability to recognize the benefits of acquisitions, including potential synergies and cost savings or the failure of acquisitions to achieve their plans and objectives. The Company cannot predict the possible impact of recently-enacted United States healthcare legislation and any similar initiatives in other countries on its results of operations. In addition to the factors described in this paragraph, Part I, Item 1A Risk Factors of our Form 10-K contains a list and description of uncertainties, risks and other matters that may affect the Company.
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