Luminex Corp, Austin, Tex, has received 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 US IVD-cleared test that can simultaneously detect 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single patient sample, according to Luminex.
“Receiving FDA clearance of MAGPIX opens the door for clinical laboratories of all sizes to use xTAG GPP on this innovative instrument,” says Patrick J. Balthrop, president and CEO, 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 the company’s xMAP® technology, the user-friendly 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.
Its compact size makes is a boon for labs with limited bench space. The system can perform up to 50 different tests in a single reaction volume, reducing sample input, reagents, and labor, while improving productivity.
While 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 5 hours.
Simultaneous molecular testing on a single sample within a single shift provides benefits labs 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, PhD, director of the Office of In Vitro Diagnostics and Radiology at the FDA’s Center for Devices and Radiological Health, when xTAG GPP was first approved by the FDA. “The test could also allow clinicians and public health professionals to more quickly identify and investigate the source of potential gastroenteritis outbreaks.”
The company will be demonstrating the instrument at booth #237. during the Clinical Virology Symposium, to be held from April 28 to May 1 in Daytona Beach, Fla, Booth
[Source: Luminex Corp]
