Luminex Receives FDA Clearance for First Comprehensive Gastrointestinal Pathogen Infectious Disease Diagnostic in the United States

Luminex Corporation has announced 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. In the United States alone, 99 million cases of GI infection occur annually, leading to over 250,000 hospitalizations and 17,000 deaths, 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.

As the first and most comprehensive multiplexed product of its kind in the United States, xTAG GPP is a nucleic acid-based amplification assay that simultaneously tests for 11 of the most common gastroenteritis causing viruses, bacteria, and parasites. The panel includes: Campylobacter, Clostridium difficile Toxin A/B, Escherichia coli O157, Enterotoxigenic E. coli (ETEC) LT/ST, Shiga-like toxin producing E. coli (STEC) stx1/stx2, Salmonella, Shigella, Rotavirus A, Norovirus GI/GII, Giardialamblia and Cryptosporidium.

Depending on the pathogen, currently available technologies and methods can take several days to deliver a single result. xTAG GPP is capable of delivering multiple results within 5 hours. The assay is cleared on the widely available Luminex® 100/200™ system. Additionally, simultaneous molecular testing on a single sample within a single shift provides significant benefit to laboratories in terms of workflow and resource utilization.

"In our experience, simultaneous testing for multiple GI pathogens during routine clinical testing and outbreak investigations enhances both our diagnostic capabilities and public health laboratory efficiency," said Dr. Sanjib Bhattacharyya, Deputy Laboratory Director at City of Milwaukee Health Department. "Routine use of xTAG GPP will allow cost-effective, timely detection of multiple pathogens, optimize use of laboratory resources, and elevate our understanding of pathogen-associated diseases in gastroenteritis."

"CE IVD marked xTAG GPP has provided significant improvement to laboratories and healthcare systems in Europe and other countries and we are pleased to provide this important diagnostic to laboratories and patients in the United States," said Patrick J. Balthrop, president and CEO of Luminex. "xTAG GPP has the potential to enable hospitals to improve patient outcomes while saving money. Our continued innovation is a reflection of the outstanding dedication of our development team and our passion for creating breakthrough solutions to improve health and advance science."

About xTAG GPP
The xTAG Gastrointestinal Pathogen Panel (GPP) is a multiplexed nucleic acid test for the detection of multiple viral, parasitic, and bacterial nucleic acids in human stool specimens from individuals with signs and symptoms of infectious colitis or gastroenteritis.

The detection and identification of specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastroenteritis aids in the diagnosis of gastrointestinal infection and the investigation of acute gastroenteritis outbreaks when used in conjunction with clinical evaluation, laboratory findings, and epidemiological information. xTAG GPP positive results are presumptive and must be confirmed by FDA-cleared tests or other acceptable reference methods.