Cepheid Announces New Diagnostic Technology to Aid World Efforts in Halting the Spread of Mycobacterium Tuberculosis (TB)

SUNNYVALE, California - Cepheid (Nasdaq: CPHD) today announced details of technology expected to
revolutionize the speed of diagnosis of Mycobacterium tuberculosis (TB) and
the resistance to common drug treatment for the disease.

The new test technology, developed in partnership with Foundation for
Innovative New Diagnostics (FIND) and the University of Medicine and
Dentistry of New Jersey (UMDNJ), and funded by the National Institute of
Allergy & Infectious Diseases (NIAID), will leverage the power of Cepheid’s
GeneXpert(R) System to deliver a highly accurate diagnosis of the disease in
less than two hours.

According to the World Health Organization (WHO), approximately two
billion people are infected with Mycobacterium tuberculosis. Each year
approximately nine million people develop active TB and two million people
lose their lives to the illness. This equates to one life every 20 seconds.

“One of FIND’s main goals is to help to save the millions of lives that
are needlessly lost to TB every year,” says Giorgio Roscigno, Chief Executive
Officer of FIND. “Cepheid’s commitment to researching and bringing this test
to market has been outstanding, as is their intention to sell Xpert(R)
MTB/RIF on a cost for product basis in the developing world, where it is most
needed. We are proud to be working with them on this project.”

Rapid diagnosis of TB is vital in areas such as sub-Saharan Africa and
Southeast Asia due to the close connection between HIV and TB. Sputum
microscopy, which often delivers poor sensitivity in patients suffering from
tuberculosis, is almost completely ineffective in those who also have HIV
co-infection. The weakened immune system of an HIV-positive person is
particularly susceptible to infection, resulting in one third of the 33
million HIV sufferers worldwide infected with TB. Left untreated, 90 percent
of these people will die within months of first contracting the disease,
reinforcing the urgent need for an accurate and rapid test.

“The need for accurate and rapid detection of tuberculosis is becoming
increasingly acute with the development of drug resistant strains and the
growing at-risk populations in the developing world,” said John Bishop,
Cepheid’s Chief Executive Officer. “The GeneXpert System has a unique level
of technical capability never before seen in molecular diagnostics and this
capability is on full display with the Xpert MTB/RIF test. Clinicians will
now be able to obtain dependable test results for not only detection of TB
but simultaneous determination of whether or not it is a drug resistant
strain in virtually any clinical setting. Appropriate therapeutic management
has been a significant factor in the development of drug resistant strains of
tuberculosis and the availability of the Xpert MTB/RIF test should be a
breakthrough technological leap forward in helping to ensure proper
therapeutic management and in helping to halt transmission. We are expecting
to make this test available as a CE IVD Mark product next month.”

Xpert MTB/RIF not only detects the presence of TB, but also identifies
whether it is resistant to Rifampicin, a common first-line drug for treatment
of the disease and a reliable surrogate marker of strains that are
multidrug-resistant (MDR-TB). The test is expected to enable physicians to
dramatically improve patient outcomes - possible only with on-demand,
actionable results to guide therapy decisions within the timeframe of an
initial patient visit.

“Multidrug-resistant TB is becoming increasingly prevalent throughout the
world, making TB harder to treat with the usual treatment regimen that
includes Rifampicin,” said David H. Persing, M.D., Ph.D., Cepheid’s Chief
Medical and Technology Officer. “In my opinion, this new test is one of the
most important diagnostic developments to have occurred in many years. It is
the most technologically advanced test for TB ever developed, yet it is
simple enough to perform in all corners of the world, including
resource-limited settings where it is most needed.”

Currently, the most common testing method for TB is the sputum
microscopy, or smear test, that has remained largely unchanged in its
sophistication and sensitivity for over 100 years. The smear test has been
proven to only detect around half of all active TB cases and is not capable
of identifying drug resistance. Patients who remain undetected are often
co-mingled within general hospital populations, placing others at risk of
infection. Due to their low accuracy, smear tests are followed up with
culture tests, which offer more accurate results but take several weeks. To
determine drug resistance, culture testing can take months to return a
result. For patients in the developing world, lengthy turnaround times of
current test methods can lead to catastrophic consequences as the chain of
transmission grows.

“We designed this test so that it could be used by someone with minimal
training,” said UMDNJ’s David Alland, M.D. who collaborated closely with
Cepheid and FIND with support from the NIAID. “We’re gratified to find that
it requires less hands-on work than the acid fast smear, long a standard
method to identify tuberculosis, but it is much more sensitive.”

About Cepheid

Cepheid (Nasdaq: CPHD), based in Sunnyvale, Calif., is a molecular
diagnostics company that develops, manufactures, and markets fully-integrated
systems 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; food, agricultural, and
environmental testing in the industrial market; and identifying bio-terrorism
agents in the biothreat market. See www.cepheid.com for more information.

About FIND

FIND, based in Geneva, Switzerland, is a not-for-profit Swiss foundation
dedicated to the development of improved diagnostics for poverty-related
diseases. FIND is dedicated to the development of tests that will have a
measurable impact on TB morbidity and mortality, particularly in high-endemic
countries. Since its establishment in 2003, FIND has received endorsement
from WHO for three new TB technologies that are currently being rolled out
with partners in 16 countries that carry a high burden of MDR TB cases.
FIND’s mission is to drive the development and implementation of accurate and
affordable diagnostic tests that can be used as near as possible to where
patients first seek care. At this time, the FIND’s disease portfolio includes
TB, malaria and human African trypanosomiasis and current donors are the Bill
& Melinda Gates Foundation, the European Union, the Government of the
Netherlands, UNITAID, Irish Aid and other institutions and private donors.
FIND is ISO 9001:2000 and ISO 13485:2003 certified. For more information,
please visit: www.finddiagnostics.org/

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 product performance and future market opportunities. 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 manufacturing problems; inherent uncertainties related to the
regulatory process; regulatory developments and practices regarding testing;
market acceptance of the product; the failure of products to perform as
expected, whether due to manufacturing errors, defects or otherwise; the
impact of competitive products and pricing; the ability of Cepheid to market
the product in other markets outside of developing countries and the pricing
and margins it receives in those markets; 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.

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

Source: Cepheid

Media, Jared Tipton, +1-408-400-8377, jared.tipton at cepheid.com, or Investors, Jacquie Ross, +1-408-400-8329, investor.relations at cepheid.com, both of Cepheid