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Dx Focus: Cepheid Xpert CT/NG; AITbiotech abTES Flu 4-Plex and MTB Real-Time Assays


Cepheid said last week that it has received clearance from the US Food and Drug Administration to market Xpert CT/NG on its GeneXpert system.

Xpert CT/NG for GeneXpert is a qualitative in vitro molecular diagnostic test to detect and differentiate Chlamydia trachomatis and Neisseria gonorrhoeae.

In a statement, David Persing, Cepheid's chief medical and technology officer, said that the test incorporates several novel design features.

"First, our research team used in silico approaches to uncover multiple genomic targets for improving the accuracy of both CT and NG detection," Persing said. "Second, we included a first-in-class sample adequacy control that we believe overcomes limitations of first-generation technologies and adds significantly to the interpretation of diagnostic results generated by the GeneXpert System."

Cepheid said that using the new test, physicians can provide same-day patient consultation and treatment for the first time.

"An on-demand test capable of delivering accurate results while patients are still present in the clinic provides a much-needed advantage in our efforts to control infectious diseases such as chlamydia and gonorrhea," Edward Hook, professor of medicine and epidemiology at the University of Alabama, Birmingham, and director of the STD Control Program for the Jefferson County Department of Health, said in a statement.

Singapore's AITbiotech said this week that it has received the CE IVD mark for its abTES Flu 4-Plex and abTES MTB real-time PCR assays for diagnosing influenza and tuberculosis infections, respectively.

The abTES Flu qPCR kit uses real-time PCR to detect and differentiate human influenza A and influenza B, and subtype swine H1, human seasonal H1, and human seasonal H3 strains in a single reaction tube. The abTES MTB qPCR Kit uses real-time PCR to detect Mycobaterium tuberculosis complex in a single reaction tube.

AITbiotech licensed the assays from Singapore's A*STAR Research Institute in 2009. The company is also seeking certification for several other abTES assays including multiplexed tests for malaria and Dengue fever.

AITbiotech said that it is the first genomics services provider in Asia to have secured ISO 13485:2003 certification for the design, development, and manufacturing of medical devices to detect infectious diseases.