Cepheid Receives FDA Emergency Use Authorization (EUA) for First 2009 H1N1 Influenza Assay for CLIA 'Moderate Complexity' Laboratories

Xpert(R) Flu A Panel Identifies the 2009 H1N1 Influenza Virus in Less Than One Hour

SUNNYVALE, California, January 4 - Cepheid (Nasdaq: CPHD) today announced it has been granted Emergency Use
Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its
Xpert(R) Flu A Panel test. The test, which runs on Cepheid's GeneXpert(R)
System, identifies the 2009 H1N1 influenza virus in less than one hour. The
FDA has authorized Cepheid's Xpert Flu A Panel to be used in laboratories
certified under the Clinical Laboratory Improvement Amendments (CLIA) to
perform "moderate complexity" (not waived) testing, enabling the test to be
performed in hospital near-patient settings.

"Accuracy combined with ease-of-use and the broad testing applicability
of the GeneXpert(R) System offers a helpful unique diagnostic solution in
helping to address this healthcare issue," said John Bishop, Cepheid's Chief
Executive Officer. "Although PCR testing is now recognized as the new gold
standard for detection of influenza virus infection, test availability for
2009 H1N1 has so far been limited to high-complexity laboratories and results
are not typically available around the clock. Xpert Flu A Panel combines the
convenience and ease-of-use of rapid testing with the performance of PCR, in
a test format that maximizes medical value by providing results when they are
most needed."

2009 H1N1 is a new influenza virus that was detected in the United States
in April 2009. As such, children and younger adults are less likely than
older people to have immunity to this virus, and illness may be more severe
and widespread as a result.(1) In June 2009, the World Health Organization
(WHO) announced the spread of the novel 2009 H1N1 virus had reached pandemic
phase 6, the highest level of pandemic alert designated by the
organization.(2)

"So far, 2009 H1N1 appears to be the predominant influenza strain this
season," said Dr. Preveen Ramamoorthy, director of molecular diagnostics at
National Jewish Health in Denver CO. "An easy-to-use, rapid PCR-based 2009
H1N1 test can assist clinicians in making real-time medical decisions that
help hospitals significantly improve their patient management."

Cepheid will continue development of an expanded influenza panel product
that it expects to test for Influenza A with strain identification for H1
seasonal and H3 seasonal influenza A subtypes, the 2009 H1N1 subtype, and
Influenza B. For that product, Cepheid expects to submit a separate 510(k) in
2010.

Cepheid expects Xpert Flu A Panel to become available in Europe as a CE
IVD Mark product under the European Directive on In Vitro Diagnostic Medical
Devices the week of December 28, 2009. Visit www.cepheidinternational.com for
Cepheid's complete CE IVD menu of Xpert tests.

About the FDA's Emergency Use Authorization

The US Secretary of Health and Human Services has declared a public
health emergency because of the outbreak of the pandemic flu virus. The FDA
has issued emergency use authorizations to make diagnostic and therapeutic
tools available to public health and medical personnel for use in the
diagnosis of 2009 H1N1 influenza virus under certain circumstances.

The FDA has not cleared or approved any tests for the identification of
the 2009 H1N1 influenza virus. The emergency use authorization authority
allows the FDA, based on the evaluation of available data, to authorize the
use of unapproved and uncleared medical products following a determination
and declaration of emergency, provided certain criteria are met. The FDA can
only grant emergency use authorization for the duration of the emergency,
which is currently set to expire on April 26, 2010, unless it is terminated
sooner or renewed. The FDA may also revoke an EUA prior to the termination of
the emergency.

About the GeneXpert System

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 contamination. The GeneXpert System is the only authorized
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 thereby
delivering answers directly from unprocessed samples. Modular in design, the
GeneXpert System has a variety of configurations to meet the broad range of
testing demands of any clinical environment.

About Cepheid

Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is an on-demand
molecular diagnostics company that develops, manufactures, and markets
fully-integrated systems and tests for genetic analysis in the clinical,
industrial and biothreat markets. The company's systems enable rapid,
sophisticated genetic testing for organisms and genetic-based diseases by
automating otherwise complex manual laboratory procedures. The company's
easy-to-use systems integrate a number of complicated and time-intensive
steps, including sample preparation, DNA amplification and detection, which
enable the analysis of complex biological samples in its proprietary test
cartridges. Through its strong molecular biology capabilities, the company is
focusing on those applications where rapid molecular testing is particularly
important, such as identifying infectious disease and cancer in the clinical
market. See www.cepheid.com for more information.

This press release contains forward-looking statements that are not
purely historical regarding Cepheid's or its management's intentions,
beliefs, expectations and strategies for the future, including those relating
to the timing of new product releases, regulatory developments and approval
and product performance. Because such statements deal with future events,
they are subject to various risks and uncertainties, and actual results could
differ materially from the company's current expectations. Factors that could
cause actual results to differ materially include risks and uncertainties
such as those relating to: unforeseen product development and manufacturing
problems; uncertainties in the regulatory review process for new products;
regulatory developments and practices regarding testing; the lack of
assurance as to the duration of the emergency authorization; customer and
market acceptance of the product; the failure of the product to perform as
expected, whether due to manufacturing errors, design defects or otherwise;
the impact of competitive products and pricing; potentially lengthy sales
cycles in some markets; reimbursement rates for the product; and underlying
market conditions worldwide. Readers should also refer to the section
entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K for 2008 and
in its most recent quarterly report on Form 10-Q, each filed with the
Securities and Exchange Commission.

All forward-looking statements and reasons why results might differ
included in this release are made as of the date of this press release, based
on information currently available to Cepheid, and Cepheid assumes no
obligation to update any such forward-looking statement or reasons why
results might differ.

References

1. CDC: Facts About Novel H1N1 Influenza; May 2009

2.
www.who.int/mediacentre/news/statements/2009/h1n1_pandemic_phase6_20090611/en/index.html

    CONTACTS:
    For Media Inquiries:                For Cepheid Investor Inquiries:
    --------------------                -------------------------------
    Jared Tipton                        Jacquie Ross
    Cepheid Corporate Communications    Cepheid Investor Relations
    +1-408-400-8377                     +1-408-400-8329
    jared.tipton@cepheid.com            investor.relations@cepheid.com

Jared Tipton, Cepheid Corporate Communications, +1-408-400-8377, jared.tipton at cepheid.com, or Jacquie Ross, Cepheid Investor Relations, +1-408-400-8329, investor.relations at cepheid.com