FDA Approves Luminex Test for Infectious Gastroenteritis

AUSTIN, TEXAS Luminex Corp. has received the green light from the U.S. Food and Drug Administration (FDA) to market a test that can simultaneously detect nearly a dozen common bacterial, parasitic and viral causes of infectious gastroenteritis from a single patient sample.

The test known as the xTag Gastrointestinal Pathogen Panel (GPP) can deliver multiple results within five hours, a vast improvement considering available methods and technologies can take several days to deliver just one result, according to Luminex, a company that manufactures biological testing technologies.

Between 1999 and 2007, gastroenteritis-associated deaths in the United States increased from nearly 7,000 to more than 17,000 per year, according to the Centers for Disease Control and Prevention. Norovirus  and Clostridium difficile a bacteria accounted for two-thirds of the deaths, FDA observed.

Infectious gastroenteritis is an inflammation of the stomach and intestines caused by certain bacteria, parasites or viruses, and common symptoms include diarrhea and vomiting.

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 whats causing gastroenteritis," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiology at the FDAs Center for Devices and Radiological Health, 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."

The test detects the following causes of gastroenteritis:

Bacteria
- Campylobacter
- Clostridium difficile (C. difficile) toxin A/B
- Escherichia coli (E. coli) O157
- Enterotoxigenic Escherichia coli (ETEC) LT/ST
- Salmonella
- Shigella
- Shiga-like Toxin producing E. coli (STEC) stx 1/stx 2

Virus
- Norovirus
- Rotavirus A

Parasite
- Cryptosporidium
- Giardia