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Luminex xTAG GPP for Gastroenteritis Gets FDA Clearance

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Luminex Corporation (LMNX) revealed that its biological testing platform xTAG Gastrointestinal Pathogen Panel (:GPP) can now add three new targets following the clearance from U.S. Food and Drug Administration (:FDA). The new targets include Adenovirus 40/41, Entamoeba histolytica and Vibrio cholera.

Further, FDA has cleared Luminex's xTAG GPP for use with specimens in Cary-Blair medium – a common transport medium for collection and preservation of microbiological specimens.

xTAG GPP is a nucleic acid test for the detection of multiple viral, parasitic, and bacterial nucleic acids in human stool specimens from individuals with signs and symptoms of infectious colitis or gastroenteritis. It is the first multiplexed U.S. IVD test cleared for infectious gastroenteritis.

xTAG GPP is efficient in identifying the causes of gastroenteritis by testing for viruses, bacteria and parasites in just one test. The testing platform is capable of detecting common viral, bacterial, and parasitic causative pathogens from a single patient sample.

xTAG GPP’s capability to perform simultaneous molecular testing on a single sample within a single shift facilitates workflow and resource utilization to laboratories. It can test for greater than 90% of the causative pathogens of infectious gastroenteritis in a single test. As a result, clinicians can identify and treat the causative agent quickly.

Infectious gastroenteritis is an inflammation of the stomach and intestines caused by certain viruses, bacteria, or parasites. Common symptoms of the disease include vomiting and diarrhea.

Gastroenteritis can become more serious in infants, the elderly, and people with inferior immune systems. This disease can spread easily through person-to-person contact, and contaminated food, water, and surfaces.

Some well-performing stocks in the medical instrument industry include Alphatec Holdings, Inc. (ATEC), ERBA Diagnostics, Inc. (ERB), and Edwards Lifesciences Corp. (EW).
 

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