Luminex Corporation Receives U.S. FDA Clearance for MAGPIX® Instrument with Novel xTAG® Gastrointestinal Pathogen Panel

Luminex Corporation today announced it has received U.S. FDA clearance of its MAGPIX instrument, with its xTAG Gastrointestinal Pathogen Panel (xTAG GPP). This is the first clinical assay to be cleared on MAGPIX. xTAG GPP is the first U.S. IVD cleared test that can simultaneously detect 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single patient sample.

"Receiving FDA clearance of MAGPIX opens the door for clinical laboratories of all sizes to use xTAG GPP on this innovative instrument," said Patrick J. Balthrop, president and chief executive officer of Luminex. "By bringing a compact, cost-effective, easy-to-deploy multiplexing solution to the clinical market, MAGPIX makes molecular testing more accessible to all laboratories."

Based on Luminex's xMAP® Technology, the easy-to-use MAGPIX instrument is a versatile multiplexing platform capable of performing qualitative and quantitative analysis of proteins and nucleic acids in a variety of sample matrices. MAGPIX is compact making it attractive to laboratories with limited bench space. This affordable system can perform up to 50 different tests in a single reaction volume, greatly reducing sample input, reagents, and labor while improving productivity.

Traditional GI testing technologies and methods can take several days to deliver a single result depending on the pathogen. xTAG GPP is capable of delivering multiple results within five hours. Simultaneous molecular testing on a single sample within a single shift provides significant benefits to laboratories in terms of workflow and resource utilization.

"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," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiology at the FDA's Center for Devices and Radiological Health in an FDA press release when xTAG GPP was first approved by the Agency. "The test could also allow clinicians and public health professionals to more quickly identify and investigate the source of potential gastroenteritis outbreaks."

Luminex will be featuring xTAG GPP and demonstrating the MAGPIX instrument at the Clinical Virology Symposium (CVS), April 28–May 1 in Daytona Beach, FL, Booth #237. For more information on MAGPIX or xTAG GPP, please visit our website at www.luminexcorp.com.
About Gastroenteritis

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

Diarrheal disease strikes more than two billion times globally each year, and is a leading cause of child morbidity and mortality worldwide(1). In the United States alone, 99 million cases of Gastrointestinal (GI) infection occur annually, leading to more than 250,000 hospitalizations(2) and 17,000 deaths(3)—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.