Cepheid wins $14.9m contract from US CDC for rapid detector of bird flu virus

15 December 2006

Sunnyvale, Calif., USA. The United States Centers for Disease Control and Prevention (CDC) has awarded Cepheid (NASDAQ:CPHD) a $14.9 million contract to develop a rapid point-of-care diagnostic system to detect influenza viruses A and B, and the H5N1 virus (also called avian influenza or bird flu) in human respiratory specimens.

An initial allocation of $2.4 million for phases 1 and 2 of the five-phase program was made on 1st December. The proposed test will be developed over a 30-month period as part of a government program directed at pandemic preparedness. Cepheid will develop a fully automated, self-contained test that does not require the user to have technical or specialized training as a "CLIA waived" product for use on its GeneXpert system.

The objective of the program is to develop a rapid, highly accurate patient test utilizing Real-Time PCR on a broadly disseminated basis in virtually any setting.

"The contract will provide funding for the development of an integrated single module GeneXpert system and a test cartridge to detect influenza viruses A and B, and H5N1, thereby providing general clinical utility for seasonal flu diagnosis in addition to its application in an influenza pandemic. In the event of an avian influenza pandemic, rapid detection of the H5N1 virus and accurate differentiation of this agent from other common causes of respiratory illness will serve a critical role in diagnosis and subsequent treatment of avian influenza cases," said Cepheid Chief Medical and Technology Officer, David H. Persing, MD, Ph.D.

"The only proven test methods based on PCR detection of the viral genome, are technically complex and are typically confined to highly specialized central laboratories. Currently available PCR systems do not provide the rapid turnaround or on-demand, 24/7 availability that is necessary for real-time decisions to be made regarding antiviral therapy or patient management. The GeneXpert system is the ideal platform for bringing state-of-the-art molecular diagnostic technology to the frontlines of medical practice," continued Dr. Persing.

According to the World Health Organization, since 2003 there have been 258 human cases of Avian Influenza, with an overall mortality rate of over 50%. Apart from vaccination, the most effective means of controlling the spread of an influenza pandemic is early case recognition, followed by isolation and antiviral therapy.

Rapid antigen-based tests available today are insensitive and are not designed to specifically identify H5N1. Antiviral treatment is most effective at treating and preventing the spread of the virus when it is given before the peak onset of influenza viral syndrome. The new Xpert Influenza test under development will detect the common forms of human influenza virus (influenza A/B) as well as the H5N1 variant directly from nasal and throat swabs in approximately 30 minutes.

"The technology embedded in the GeneXpert platform constitutes precisely what developing nations like Indonesia need in combating threats like avian influenza. The ease, simplicity and relatively low cost of the diagnosis of H5N1 virus using this assay system will allow an expanded reach and reliability of surveillance to levels unimaginable with currently deployed diagnostic technologies," said J. Kevin Baird, Ph.D., Director, ALERTAsia Foundation, Jakarta, Indonesia, a collaborator in the contract that will provide samples for testing.

"ALERTAsia looks forward to working with our committed friends at Cepheid, the Eijkman Institute for Molecular Biology, the National Institute of Health Research and Development of the Republic of Indonesia, the U.S. Department of Health and Human Services, and the U.S. Centers for Disease Control and Prevention in making this bright vision a reality across the length of the Indonesian archipelago."

About the GeneXpert molecular diagnostic platform

The GeneXpert System is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of false positive results due to contamination. The GeneXpert System is the only system to combine on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences and deliver diagnostic answers from unprocessed samples in approximately 30 minutes, whereas manual testing methods comprising the same advanced technology require several hours to several days. Cepheid's Xpert GBS test recently received FDA clearance for use in CLIA "Moderate Complexity" laboratories, the first such designation for a PCR-based test. The modular design of the GeneXpert Platform allows it to be adapted to a variety of laboratory environments, ranging from high-volume testing in reference and hospital laboratories to use in physician offices and urgent care centers.

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