Press release from Business Wire
Meridian Bioscience Receives FDA Clearance for New Molecular Test: illumigene® Group A Strep
Monday, September 17, 2012
CINCINNATI (Business Wire) -- Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ: VIVO) today announced that it has received FDA clearance for a new molecular diagnostic test for Group A Streptococcus on the illumigene® platform.
Group A Streptococcus is a bacterium commonly found in the human throat or on skin and causes a wide variety of diseases in humans, the most common being acute pharyngitis or strep throat. Group A Streptococcus infections may result in mild illness (e.g. pharyngitis, impetigo) or may lead to invasive, life-threatening illness such as acute rheumatic fever, cellulitis, bacteremia, necrotizing fasciitis, or Streptococcal toxic shock syndrome.
illumigene Group A Strep represents a significant new advancement in healthcare by providing a molecular solution 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. Approximately 20-30% of children seeking physician care are diagnosed with Group A Strep pharyngitis. Traditional laboratory diagnosis is performed by rapid antigen testing or throat swab culture. Studies show that culture may miss up to 10% of true positives.
Accurate diagnosis of streptococcal pharyngitis followed by appropriate antibiotic therapy is important for the prevention and control of Group A Strep infections. The illumigene Group A Strep test utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus pyogenes in throat samples. The test procedure is remarkably simple and highly sensitive. It requires no expensive capital equipment. The test relies upon a simple procedure that takes less than one hour. All reagents and disposables are contained in the test kit and can be stored at room temperature. The simplicity of this technology, along with its cost efficiency, make this innovative test ideal for helping in early diagnosis and proper patient management of this common and serious disease.
Donna Mayne, Supervisor of the Microbiology, Serology and Molecular Laboratories at Sacred Heart Hospital in Pensacola, Florida states, "The utilization of GAS molecular testing decreases our turnaround time and offers increased sensitivity."
Rick Eberly, Chief Commercial Officer stated, “illumigene Group A Strep is a significant addition to Meridian's illumigene menu, especially as it offers the advantages of both faster and more accurate strep throat diagnostic results. This test continues the expansion of our illumigene technology, which allows healthcare professionals to implement a sophisticated molecular amplification test that is affordable, quick and easily administered in any lab or hospital setting.”
Furthermore, Jack Kraeutler, Chief Executive Officer, stated, “Meridian continues to focus on developing innovative technologies that help reduce the overall costs of healthcare. Our diagnostic tests are specifically developed for faster and more accurate detection and early diagnosis of acute infectious disease-causing pathogens. With illumigene Group A Strep, healthcare providers and patients can get a definitive strep throat diagnosis rapidly. As a result, they can help their patients reduce the risks of Group A Strep transmission and complications which ultimately contributes to decreasing healthcare costs.”
FORWARD LOOKING STATEMENTS
The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil litigation for forward-looking statements accompanied by meaningful cautionary statements. Except for historical information, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, which may be identified by words such as "estimates", "anticipates", "projects", "plans", "seeks", "may", "will", "expects", "intends", "believes", "should" and similar expressions or the negative versions thereof and which also may be identified by their context. Such statements, whether expressed or implied, are based upon current expectations of the Company and speak only as of the date made. The Company assumes no obligation to publicly update or revise any forward-looking statements even if experience or future changes make it clear that any projected results expressed or implied therein will not be realized. These statements are subject to various risks, uncertainties and other factors that could cause actual results to differ materially, including, without limitation, the following:
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 main 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.
Meridian is a fully integrated life science company that 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 treatment of common medical conditions, such as gastrointestinal, viral and respiratory infections. Meridian's diagnostic products are used outside of the human body and require little or no special equipment. The Company's products are designed to enhance patient well-being while reducing the total outcome costs of healthcare. Meridian has strong market positions in the areas of gastrointestinal and upper respiratory infections, serology, parasitology and fungal disease diagnosis. In addition, Meridian is a supplier of rare reagents, specialty biologicals and related technologies used by biopharmaceutical companies engaged in research for new drugs and vaccines. The Company markets its products and technologies to hospitals, reference laboratories, research centers, diagnostics manufacturers and biotech companies in more than 60 countries around the world. The Company's shares are traded through NASDAQ's Global Select Market, symbol VIVO. Meridian's website address is www.meridianbioscience.com.
Meridian Bioscience, Inc.
John A. Kraeutler, Chief Executive Officer, 513-271-3700