FDA Approves Test That Can Identify Multiple Causes of Infectious Gastroenteritis

The xTAG Gastrointestinal Pathogen Panel can simultaneously detect 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single patient sample.

The FDA announced January 14 that it has cleared Luminex Corporation to market its xTAG Gastrointestinal Pathogen Panel (GPP), which Luminex describes as “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.”

According to Luminex, the xTAG GPP is “a nucleic acid-based amplification assay that simultaneously tests for 11 of the most common gastroenteritis causing viruses, bacteria, and parasites:”

  • 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
  • Cryptosporidium

The FDA said that to gain approval, Luminex “demonstrated the performance of the xTAG GPP by collecting samples from 1,407 patients with suspected infectious gastroenteritis and comparing the xTAG GPP results to individual tests that are known to separately and reliably detect the 11 viruses, bacteria, or parasites associated with the xTAG GPP. The manufacturer also ran the test on 203 samples from patients with previously confirmed infectious gastroenteritis, and 313 additional specimens from pediatric patients with suspected infectious gastroenteritis.” The xTAG GPP produced results that were comparable to the pre-existing individual tests.

In the FDA news release, Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiology at the FDA’s Center for Devices and Radiological Health, said that “Tests such as the XTag GPP that can detect viruses, bacteria, and parasites from one sample at the same time can help clinicians more quickly identify and treat what’s causing gastroenteritis. The test could also allow clinicians and public health professionals to more quickly identify and investigate the source of potential gastroenteritis outbreaks.”