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FDA approves test that detects 11 causes of infectious gastroenteritis from single sample

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The FDA approved on Jan. 14 marketing for a test that simultaneously detects multiple causes of infectious gastroenteritis, according to a press release.

The xTAG Gastrointestinal Pathogen Panel (GPP), manufactured by Luminex, detects 11 viral, bacterial and parasitic causes of gastroenteritis, including Clostridium difficile toxin A/B, Escherichiacoli O157, Salmonella, Shigella, norovirus, rotavirus A, Cryptosporidium and giardia. It is the first test capable of simultaneously detecting each factor from a single sample.

Approval for xTAG GPP followed results of a study comparing its efficacy with that of individual tests that detected each cause of gastroenteritis, incorporating data from 1,407 adult patients and 313 pediatric patients with suspected infectious gastroenteritis, as well as 203 patients with confirmed gastroenteritis. The xTAG GPP performed comparably to individual tests, the release said, but additional testing is necessary for all positive results.

“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,” Alberto Gutierrez, PhD, director of the FDA Center for Devices and Radiological Health Office of In Vitro Diagnostics and Radiology, said in the release. “The test could also allow clinicians and public health professionals to more quickly identify and investigate the source of potential gastroenteritis outbreaks.”