Newly CE-Marked Automated Respiratory Disease Assay Now Available

A dedicated “laboratory in a cartridge” that enables the simultaneous diagnosis of influenza A and B and RSV (respiratory syncytial virus) is now available for use on one of the world's leading diagnostic platforms.

The patented, single use Xpert Flu/RSV XC assay runs on Cepheid's (Sunnyvale, CA, USA; www.cepheid.com) GeneXpert System, one of the world's leading molecular diagnostic platforms with more than 7,000 systems installed to date.

A dedicated GeneXpert cartridge, which centralizes sample extraction, amplification, and detection, is now available for 18 different pathogens. The cartridge is the heart of the GeneXpert system, which includes instruments in 1, 2, 4, 16, 48, or 80-module configurations.

"We employed a novel in silico approach to identify multiple complementary target segments to avoid the effects of seasonal genetic drift and to anticipate emerging novel influenza strains. Though simple to perform, Xpert Flu/RSV XC is a highly multiplexed, state-of-the-art test for rapid and accurate detection and differentiation of Flu A, Flu B, and RSV infection," said Dr. David Persing, Chief Medical and Technology Officer at Cepheid. "This test may also become a valuable asset in efforts toward pandemic preparedness because it was designed from its inception to provide unprecedented coverage of avian influenza strains."

The Xpert Flu/RSV XC assay will begin shipping in September 2014 as a CE-IVD Marked product.

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