Luminex Wins FDA Clearance for Xtag Gastro Pathogen Paenl

Luminex Corporation LMNX announced today that it has received FDA clearance for its xTAG Gastrointestinal Pathogen Panel (GPP), the first comprehensive molecular diagnostic assay that tests for greater than 90% of bacterial, viral, and parasitic causes of infectious gastroenteritis in a single assay. The xTAG GPP assay can be an important clinical tool in the management of gastrointestinal infections, and is now available in the United States. Diarrheal disease strikes more than two billion times globally each year and is a leading cause of child morbidity and mortality worldwide(1). In the United States alone, 99 million cases of GI infection occur annually, leading to over 250,000 hospitalizations(2) and 17,000 deaths(3), inflicting a significant toll on the healthcare system. Diagnosis of some causes of infectious gastroenteritis has traditionally required multiple tests across the microbiology, virology, and molecular laboratories for which results may not be available for several days.