The U.S. regulatory sign-off for the company's MAGPIX instrument allows its use with the company's xTAG gastrointestinal test, which gained de novo clearance about 6 weeks earlier in conjunction with one of the company's older systems.
In discussing the approval with FierceMedicalDevices, Luminex president and CEO Patrick Balthrop wasn't shy about making bold statements.
"This is the first product of its kind in the history of mankind," Balthrop told us. "In a matter of a few hours [it] can do differential diagnostics … it will cure the patient, improve clinical outcomes and reduce cost."
Luminex asserts that xTAG is the first IVD test of its kind cleared in the U.S. that can use a single fecal sample to detect 11 different viral, bacterial and parasitic causes of infectious gastroenteritis at the same time. The current standard of care involves taking a sample and culturing it in the lab, a process that can take days. But the company bills the xTAG nucleic acid test as something that can bring multiple results to fruition within five hours. The FDA previously thought enough of the test to issue a release, noting, for example, it could help address gastroenteritis outbreaks more quickly. And the MAGPIX device that handles the test is meant to make the process as easy as possible, relatively light weight with light-emitting diodes and a CCD imaging system to help it perform its job.
Balthrop told FierceMedicalDevices that the company will market the new test system primarily to "very large integrated delivery networks and medical centers." He termed the patient targets for the test as "high risk, geriatric, pediatric, or immune suppressed," perhaps because of cancer or organ transplantation.
The company's potential market is enormous. As Luminex notes in its announcement, the United States alone handles 99 million gases of gastrointestinal infection each year, of which 250,000 people are hospitalized and 17,000 typically die.
- read the release