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FDA Clears New Targets for Luminex GI Pathogen Panel

E. coli bacteria
E. coli bacteria

Luminex Corporation this week announced it has received U.S. FDA clearance to add three new targets to its xTAG Gastrointestinal Pathogen Panel (GPP).

The new targets include Adenovirus 40/41, Entamoeba histolytica and Vibrio cholerae.

As the first multiplexed U.S. IVD cleared test for infectious gastroenteritis, xTAG GPP simultaneously detects 14 common viral, bacterial, and parasitic causative pathogens from a single patient sample.

The xTAG GPP panel now detects the following potential causes of gastroenteritis:

  • Campylobacter
  • Clostridium difficile toxin A/B
  • Escherichia coli (E. coli) O157
  • Enterotoxigenic E. coli (ETEC) LT/ST
  • Salmonella
  • Shigella
  • Shiga-like Toxin producing E. coli (STEC) stx 1/stx 2
  • Vibrio cholerae, cholera toxin gene (ctx)
  • Adenovirus 40/41
  • Norovirus
  • Rotavirus A
  • Cryptosporidium
  • Entamoeba histolytica
  • Giardia

By testing for greater than 90% of the causative pathogens of infectious gastroenteritis in a single test, clinicians can more quickly identify and treat the causative agent. Additionally co-infections can be more easily identified.

Simultaneous molecular testing on a single sample within a single shift also provides significant benefits to laboratories in terms of workflow and resource utilization. The ability to scale throughput by processing 96-well plates allows laboratories to easily tailor their sample processing to physician demand.

In addition, the company announced FDA has cleared the panel for use with specimens in Cary-Blair medium, a common transport medium for collection and preservation of microbiological specimens.

“We are pleased to receive clearance for this new specimen medium and these additional clinical targets which provide even more flexibility to our customers,” said Patrick J. Balthrop, president and chief executive officer of Luminex. “As laboratories are being asked to do more with less, we are continually working to deliver solutions that meet the varied needs of our customers.”

Source: Luminex press release, adapted. xTAG is a registered, protected term of Luminex.

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