FDA Approves Luminex Gastrointestinal Diagnostic Test

Biotech firm Luminex (NASDAQ: LMNX  ) announced in a press release this week that it has gained FDA regulatory approval for its xTAG Gastrointestinal Pathogen Panel diagnostic. The product simultaneously tests for more than 90% of causes behind infectious gastroenteritis.

Several tests have been approved in the past for individual causes of gastroenteritis, which can have viral, bacterial, and parasitic causes. Luminex's product is comparable to those prior diagnostics while compiling them into a single test. According to the CDC, around 17,000 deaths were attributed to gastroenteritis in 2007.

Luminex President and CEO Patrick J. Balthrop commented on the approval in the release, saying the test "has provided significant improvement to laboratories and health care systems in Europe and other countries and we are pleased to provide this important diagnostic to laboratories and patients in the United States. ... xTAG GPP has the potential to enable hospitals to improve patient outcomes while saving money."

The approval continues Luminex's strong start to the year. So far in 2013, shares of the company are up more than 6%.


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9/30/2016 4:00 PM
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