FDA News

FDA approves new clinical targets for Luminex xTAG GI pathogen panel

Luminex has received FDA approval to add three new targets to its xTAG Gastrointestinal Pathogen Panel, including adenovirus 40/41, Entamoeba histolytica and Vibrio cholerae, according to a company press release.

The panel also has been cleared for use with specimens in the commonly used Cary-Blair transport medium.

xTAG Gastrointestinal Pathogen Panel (GPP) is the first multiplexed US in vitro diagnostic-cleared test for infectious gastroenteritis capable of simultaneously detecting “14 common viral, bacterial and parasitic causative pathogens from a single patient sample,” the release said. These account for 90% of the causative pathogens of infectious gastroenteritis, according to the release, and the major benefits include rapid identification and treatment, easier identification of coinfections and improvements to laboratory workflow and resource utilization.

“xTAG GPP helps me quickly identify the causes of gastroenteritis by testing for viruses, bacteria and parasites in one test,” Anami Patel, PhD, director at Le Bonheur Children’s Hospital, said in the release. “Additionally, I have the flexibility to tailor the xTAG GPP test to physician orders which is useful for customizing the panel to different patient populations.

“Because I can process many samples at one time with the scalable format of xTAG GPP, I can be more efficient in my laboratory testing meeting increased demand when necessary which is especially important in outbreak situations.”

Luminex will exhibit xTAG GPP at Infectious Disease Week 2014 in Philadelphia.

Luminex has received FDA approval to add three new targets to its xTAG Gastrointestinal Pathogen Panel, including adenovirus 40/41, Entamoeba histolytica and Vibrio cholerae, according to a company press release.

The panel also has been cleared for use with specimens in the commonly used Cary-Blair transport medium.

xTAG Gastrointestinal Pathogen Panel (GPP) is the first multiplexed US in vitro diagnostic-cleared test for infectious gastroenteritis capable of simultaneously detecting “14 common viral, bacterial and parasitic causative pathogens from a single patient sample,” the release said. These account for 90% of the causative pathogens of infectious gastroenteritis, according to the release, and the major benefits include rapid identification and treatment, easier identification of coinfections and improvements to laboratory workflow and resource utilization.

“xTAG GPP helps me quickly identify the causes of gastroenteritis by testing for viruses, bacteria and parasites in one test,” Anami Patel, PhD, director at Le Bonheur Children’s Hospital, said in the release. “Additionally, I have the flexibility to tailor the xTAG GPP test to physician orders which is useful for customizing the panel to different patient populations.

“Because I can process many samples at one time with the scalable format of xTAG GPP, I can be more efficient in my laboratory testing meeting increased demand when necessary which is especially important in outbreak situations.”

Luminex will exhibit xTAG GPP at Infectious Disease Week 2014 in Philadelphia.