Meridian Bioscience, Inc. (NASDAQ: VIVO), today announced that it has entered into a technology and commercial license agreement with the University of Tennessee Research Foundation (UTRF) for the development of an innovative new technology that has the potential to result in a low cost, point-of-care detection platform capable of detecting proteins, small molecules, bacteria and viruses in minutes.
The University of Tennessee technology is based on electrokinetic impedance sensing using microelectrode sensor chips. These chips are able to directly detect very minute levels of a specific analyte from complex biological samples. The device works by measuring the change in electrical properties of the chip without the use of labels or expensive optical instrumentation. In addition, detection occurs in a very specific area of the chip which lessens the amount of sample required and eliminates complex sample processing inherent to other diagnostic technologies, including PCR.
The University of Tennessee scientific team has demonstrated the effectiveness of this sensor technology by detecting tuberculosis, a disease which is estimated to be responsible for the deaths of two million people annually worldwide. Meridian has validated these findings by detecting the human Influenza A virus directly from clinical samples in approximately two minutes.
Jack Kraeutler, Chief Executive Officer, commented, “This new technology is still in the early development stage and presents Meridian and its R&D team with the opportunity to take advantage of recent progress in microelectronics and chip fabrication in the development of this novel 'sample in–result out' platform. This technology has the potential to do in minutes what it takes an hour to perform on existing diagnostic assays. We appreciate very much the cooperative and collaborative efforts of the UTRF, its researchers and its leadership. We believe this sensor technology can provide a basis for more rapid disease detection in an easy-to-use format.”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, and its ability to effectively sell such products. 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 U.S. healthcare legislation enacted in 2010 – the Patient Protection and Affordable Care Act, as amended by the Healthcare and Education Reconciliation Act – and any modification or repeal of any of the provisions thereof, 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.