Luminex grabs FDA clearance for stomach bug diagnostic
Several viruses, bacteria and parasites cause the infectious stomach flu, for which individual tests have proven effective in the past. But Luminex's xTAG Gastrointestinal Pathogen Panel (GPP), a multiplexed nucleic acid test, detects 11 causes of the disease at the same time, and its detection is comparable to existing tests for each of the causes, the FDA says.
The FDA put the xTAG GPP through its de novo clearance process because the diagnostic is low- to moderate-risk and in a different category than those already on the market.
"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 of the FDA's Center for Devices and Radiological Health said in a statement. "The test could also allow clinicians and public health professionals to more quickly identify and investigate the source of potential gastroenteritis outbreaks."
And Luminex CEO Patrick J. Balthrop wrote that "xTAG GPP has the potential to enable hospitals to improve patient outcomes while saving money."
The Centers for Disease Control and Prevention reports that the number of deaths in the U.S. related to gastroenteritis rose from 7,000 to 17,000 per year between 1999 and 2007.