NEW Product Technology


Luminex Gets FDA Clearance for Comprehensive Gastrointestinal Pathogen Infectious Disease Dx

Luminex200 copyLuminex Corp, Austin, Tex, has received FDA clearance for its xTAG Gastrointestinal Pathogen Panel (GPP), a comprehensive molecular diagnostic assay that tests for greater than 90% of bacterial, viral, and parasitic causes of infectious gastroenteritis in a single assay.

The assay can be an important clinical tool in the management of gastrointestinal infections.

The nucleic acid-based amplification assay 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, giardia lamblia, and cryptosporidium.

The assay is capable of delivering multiple results within 5 hours. It is cleared on the Luminex® 100/200™ system (pictured). Additionally, simultaneous molecular testing on a single sample within a single shift provides significant benefit to laboratories in terms of workflow and resource utilization, according to the company.

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 more than 250,000 hospitalizations(2) and 17,000 deaths(3), Luminex notes. Diagnosis of some causes of infectious gastroenteritis has traditionally required multiple tests across the microbiology, virology, and molecular labs for which results may not be available for several days.

[Source: Luminex Corp]