Luminex Corporation 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."