Luminex Corporation, a biotechnology company develops, manufactures and markets innovative biological testing technologies with applications throughout the clinical diagnostic and life science industries, has received US FDA clearance to add three new targets to its xTAG Gastrointestinal Pathogen Panel (GPP).

The targets include Adenovirus 40/41, Entamoeba histolytica and Vibrio cholerae. In addition, FDA has now cleared xTAG GPP for use with specimens in Cary-Blair medium, a common transport medium for collection and preservation of microbiological specimens.

"xTAG GPP helps me quickly identify the causes of gastroenteritis by testing for viruses, bacteria and parasites in one test," said Dr. Anami Patel, Director at Le  Bonheur Children's Hospital.  "Additionally, I have the flexibility to tailor the xTAG GPP test to physician orders which is useful for customising 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."

As the first multiplexed US IVD cleared test for infectious gastroenteritis, xTAG GPP simultaneously detects 14 common viral, bacterial, and parasitic causative pathogens from a single patient sample. By testing for greater than 90 per cent of the causative pathogens of infectious gastroenteritis in a single test, clinicians can more quickly identify and treat the causative agent. Additionally co-infections can be more easily identified.

Simultaneous molecular testing on a single sample within a single shift also provides significant benefits to laboratories in terms of workflow and resource utilisation. The ability to scale throughput by processing 96-well plates allows laboratories to easily tailor their sample processing to physician demand.

"We are dedicated to our customers and strive to continually update and improve our products to advance the delivery of health care," said Patrick J. Balthrop, president and chief executive officer of Luminex. "We are pleased to receive clearance for this new specimen medium and these additional clinical targets which provide even more flexibility to our customers. As laboratories are being asked to do more with less, we are continually working to deliver solutions that meet the varied needs of our customers."

Luminex will be featuring xTAG GPP at Infectious Disease Week, IDSA Annual Meeting, October 8–12 in Philadelphia, PA.

Infectious gastroenteritis is an inflammation of the stomach and intestines caused by certain viruses, bacteria, or parasites. Common symptoms include vomiting and diarrhoea, which can be more severe in infants, the elderly, and people with suppressed immune systems. Gastroenteritis can be spread easily through person-to-person contact, and contaminated food, water, and surfaces.

Diarrhoeal disease strikes more than two billion times globally each year, and is a leading cause of child morbidity and mortality worldwide. In the United States alone, 99 million cases of Gastrointestinal (GI) infection occur annually, leading to more than 250,000 hospitalizations and 17,000 deaths—inflicting a significant toll on the healthcare system. Diagnosis of some causes of infectious gastroenteritis has traditionally required multiple tests across the microbiology, virology, and molecular laboratories for which results may not be available for several days.

xTAG Gastrointestinal Pathogen Panel is a multiplexed nucleic acid test for the detection of multiple viral, parasitic, and bacterial nucleic acids in human stool specimens from individuals with signs and symptoms of infectious colitis or gastroenteritis. xTAG GPP detects the following potential causes of gastroenteritis.