Luminex Corporation announced that it has received CE marking for its new xTAG Gastrointestinal Pathogen Panel (GPP).This innovative assay is the first test of its kind to help identify up to 95 per cent of the disease causing pathogens in a single test. It delivers the highest number of relevant answers per sample in time to positively affect patient care.
Infectious gastroenteritis strikes more than two billion times globally each year and is a leading cause of child morbidity and mortality worldwide. In the European Union, 207 million cases of diarrhoea occur which lead to greater than 200,000 hospitalizations and over 1,000 deaths every year, inflicting a significant toll on the health care system.
As the most comprehensive test available to diagnose gastrointestinal infections, xTAG GPP simultaneously detects fifteen of the most common disease-causing pathogens, including viral, bacterial and parasitic infections, such as E. coli, Campylobacter, Salmonella and C. difficile. Providing accurate and timely identification of causative pathogens ultimately leads to improved health care outcomes and reduced costs. Additionally, the fast turn-around time and simultaneous testing on a single sample enable laboratories to better utilize their time and resources.
"The difficulty associated with diagnosing gastrointestinal infections can be frustrating for both physicians and patients when lab tests are inconclusive and effective treatment cannot be initiated, causing delays in therapy and increasing the cost of health care," said Jeremy Bridge-Cook, Ph.D., senior vice president of Luminex's assay group. "xTAG GPP promises to be a significant advance that will improve the care of patients suffering from pathogen-induced diarrhoea."
Achieving definitive diagnosis of diarrhoeal disease and infectious gastroenteritis traditionally requires multiple tests for which results are not available for several days. Although high risk patients such as children under the age of five, the elderly, and immunocompromised individuals suffering from these diseases could benefit from rapid diagnosis and intervention, physicians may be unable to initiate treatment until a definitive diagnosis is made to avoid the potential for unnecessary and inappropriate antibiotic or therapeutic use.
"Physicians and laboratory directors consistently tell us that they need more clinically useful information for their patients and that they want that information delivered faster," said Patrick J. Balthrop, president and CEO of Luminex. "Developing xTAG GPP, a robust method to quickly, accurately and actionably identify pathogens of such varied types was a significant innovation challenge, and this CE mark is a reflection of the outstanding accomplishment of our development team."
xTAG GPP is a polymerase chain reaction-based molecular test that enables multiple analyses for nucleic acids in a single reaction well. The test kit simultaneously detects and identifies 15 parasitic, bacterial and viral pathogens isolated from a single stool sample and returns results within an unprecedented five hours.
The xTAG GPP test kit is CE marked for the MAGPIX and Luminex 100/200 systems and is commercially available in Europe from Luminex. Luminex intends to file for regulatory approval in the United States and Canada.
Luminex Corporation develops, manufactures and markets proprietary biological testing technologies with applications throughout the diagnostic and life sciences industries. The company's xMAP multiplex solutions include an open-architecture, multi-analyte technology platform that delivers fast, accurate and cost-effective bioassay results to markets as diverse as pharmaceutical drug discovery, clinical diagnostics and biomedical research, including genomic and proteomic research markets.