FDA Nod for Luminex Offering - Analyst Blog

Diagnostic testing technologies company, Luminex Corporation ( LMNX ) has won clearance from the U.S. Food and Drug Administration for its MAGPIX instrument, with its xTAG Gastrointestinal Pathogen Panel (xTAG GPP).

The MAGPIX multiplexing instrument is used to assay proteins and nucleic acids in a variety of sample matrices and is capable of performing 50 tests in a single reaction volume. It is the first clinical assay that has been cleared by the FDA.

The xTAG GPP is a complete multiplexed offering, which received the FDA clearance in Jan 2013. The assay concurrently tests for as many as 11 of the most frequently occurring causes of gastroenteritis. Its ability to provide results in less than five hours renders it far superior to traditional gastrointestinal testing devices, which can take days to deliver results.

According to the Cleveland Clinic and the Centers for Disease Control and Prevention (CDC), gastrointestinal infections afflict about 99 million people in the U.S., leading to above 250,000 hospitalizations and 17,000 deaths in a year. Its most common symptoms are vomiting and diarrhea. Diarrhea is a leading cause of child morbidity and mortality across the world, as per the World Health Organization (WHO).

Our Take

The FDA clearance of the compact and easy-to-install MAGPIX instrument has made the novel xTAG GPP technology more accessible to clinical laboratories. The MAGPIX can be deployed anywhere in the world.

We believe that the xTAG GPP assay will drive long-term growth for the company based on its unique features along with an estimated market opportunity of $150 million. The company is awaiting FDA approval for its NeoPlex4 assays to drive future growth.

Moreover, Luminex is developing innovative platforms by combining resources from its latest acquisitions. The company's initiative to establish a direct sales force for its molecular diagnostics customers will likely improve operating efficiency.

However, Luminex operates in a highly competitive life sciences industry. Sluggish growth in its core markets as well as the ongoing global austerity measures are challenges for the company.

The stock carries a Zacks Rank #3 (Hold). Medical instrument companies, such as Cepheid ( CPHD ) and Cyberonics ( CYBX ) with a Zacks Rank #1 (Strong Buy) as well as Abiomed ( ABMD ) with a Zacks Rank #2 (Buy) are expected to do well.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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