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