Luminex Releases GI Assay in United States
Posted on January 21, 2013 @ 02:06 pm
Austin, Texas-based Luminex Corporation has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance for its xTAG gastrointestinal (GI) pathogen panel (GPP) molecular diagnostics assay. According to the company, the assay tests for more than 90 percent of bacterial, viral, and parasitic causes of infectious gastroenteritis in a single assay. The xTAG GPP assay can be an important clinical tool in the management of gastrointestinal infections, Luminex claims, and now is available in the United States.
Diarrheal disease occurs more than 2 billion times globally each year and is a leading cause of sickness and death among the world’s children. In the United States alone, 99 million cases of GI infection occur annually, leading to more than 250,000 hospitalizations (according to data from the Cleveland Clinic) and 17,000 deaths (according to data from the Centers for Disease Control and Prevention). Diagnosis of some causes of infectious gastroenteritis traditionally has required multiple tests across microbiology, virology, and molecular laboratories for which results may not be available for several days.
Depending on the pathogen, currently available technologies and testing methods can take several days to deliver results. The xTAG GPP reportedly is capable of producing results within 5 hours and is cleared on the Luminex 100/200 analyzer system. Additionally, simultaneous molecular testing on a single sample within a single shift provides significant benefit to laboratories in terms of workflow and resource utilization, Luminex claims.
“In our experience, simultaneous testing for multiple GI pathogens during routine clinical testing and outbreak investigations enhances both our diagnostic capabilities and public health laboratory efficiency,” said Sanjib Bhattacharyya, Ph.D., deputy laboratory director at the Milwaukee, Wis., Health Department. “Routine use of xTAG GPP will allow cost-effective, timely detection of multiple pathogens, optimize use of laboratory resources, and elevate our understanding of pathogen-associated diseases in gastroenteritis.”
“xTAG GPP has the potential to enable hospitals to improve patient outcomes while saving money,” said Patrick J. Balthrop, president and CEO of Luminex.
The xTAG GPP has been CE marked for sale in Europe and, according to Balthrop, has provided “significant improvement to laboratories and healthcare systems” in the countries where it is approved.
Luminex develops, manufactures and markets biological testing technologies for the diagnostic and life science industries.
Please visit our sister sites:
The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.