Cepheid said this week that the US Food and Drug Administration has cleared its GeneXpert Infinity-80 system in conjunction with its Xpert Flu test
The GeneXpert Infinity-80 is a high-throughput, fully automated system designed to deliver around-the-clock results for various clinical testing applications, Cepheid said. The system is designed to adapt to any workflow requirement, including on-demand, batch, or STAT testing, and is available in configurations of 16, 24, 32, 40, 48, 56, 64, 72, and 80 modules.
"With the capability of generating more than two thousand automated results per day, the GeneXpert Infinity-80 is the most efficient, highest throughput molecular diagnostic system on the market delivered in the same footprint as our current Infinity-48 System," Cepheid CEO John Bishop said in a statement.
The new system will be available for shipment on July 1, Cepheid said.
Cepheid also said this week that it has received CE marking for its Xpert CT/NG and Xpert CT assays.
The tests, which run on Cepheid's GeneXpert system, are qualitative in vitro molecular diagnostic assays to rapidly detect and differentiate Chlamydia trachomatis and Neisseria gonorrhoeae infections.
Cepheid said that it expects to begin shipping the assays immediately. The company expects Xpert CT/NG to become available in the US late this year.
Transgenomic said this week that it has received CE IVD marking in Europe for its WAVE MCE system and Surveyor Scan KRAS kit.
The company's Surveyor Scan technology uses a PCR amplification reaction and hybridization to form mispaired DNA molecules where there are mutations. A digestion step is then performed using Surveyor nuclease, which cuts the DNA strands at these mismatched base pairs. The different sized pieces of DNA can then be differentiated from non-mutant DNA using Transgenomic's Wave MCE, or micro-capillary electrophoresis, chip.
The Surveyor Scan KRAS kit will be distributed in Europe through Transgenomic's agreement with A. Menarini Diagnostics (PCR Insider, 11/10/2011).