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Cepheid Announces FDA Clearance of Group B Strep Test Utilizing Smart Cycler(R) Systems
Thursday November 21, 7:02 am ET
GBS Test Cleared for Commercialization in U.S. Markets


SUNNYVALE, Calif., Nov. 21 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD - News), a leading developer, manufacturer and marketer of fully integrated systems that enable genetic assessment, today announced that the IDI-Strep B(TM) test designed and developed by its joint venture partner, Infectio Diagnostic (IDI), has been cleared by the U.S. Food and Drug Administration for commercialization in U.S. markets. The test, which runs on Cepheid`s Smart Cycler® instrument, is intended to be used to detect the presence of Group B Streptococcus (GBS) in pregnant women at the time they enter labor and delivery. IDI-Strep B is the first and currently only test cleared by the FDA that meets the performance criteria for GBS detection recommended by the latest guidelines issued by the Centers for Disease Control and Prevention (CDC).
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Cepheid`s Smart Cycler instrument facilitates the speed and accuracy of the IDI-Strep B test. The test can provide a highly accurate result in as little as 30 minutes, during the critical period when detection of GBS may potentially reduce the number of infections and deaths to newborns caused by the bacterium.

"FDA clearance of the IDI GBS test represents a significant milestone with regard to our plans to enter the clinical market with applications where rapid genetic DNA testing is particularly important," said Chief Executive Officer John Bishop. "The IDI-Strep B test may be on the U.S. market as early as the first quarter of 2003.

According to an article appearing in The New England Journal of Medicine(1), "Group B streptococcus is a leading cause of sepsis, meningitis, and death among newborn infants in Western countries. Early-onset infections (those appearing within seven days after birth) with this organism account for approximately 80 percent of group B streptococcal infections in infants and are usually acquired by contact with the genital tract of the mother during labor and delivery.(2) In 1998, the incidence of disease caused by group B streptococci was 0.6 per 1000 live births, and there were about 2000 group B streptococcal infections among infants in the United States, approximately 100 of which were fatal.(3) Infants who have such infections may require prolonged hospitalization, and those who survive may have mental retardation or visual loss. Among pregnant women, the prevalence of colonization with group B streptococci ranges from 15 to 40 percent.(2) Women who are carriers are also at risk for severe infections.(4)"

About Cepheid

Cepheid, based in Sunnyvale, Calif., is a leading developer, manufacturer and marketer of fully integrated systems that enable genetic assessment when and where it is needed. Founded in 1996, the company is commercializing its technology and products world wide for research, medical, and industrial applications requiring assessment of the human genome, infectious disease and biothreat agents. 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. 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.

Forward-looking statements in this release include, but are not limited to, statements regarding the performance and benefits of the IDI-Strep B test and Cepheid`s Smart Cycler® system, and the timing of market introduction of the test. It is important to note that actual outcomes and Cepheid`s actual results could differ materially from those in such forward-looking statements. Factors that could cause actual results to differ materially include risks and uncertainties relating to: the functionality and performance of the IDI-Strep B test and of Cepheid`s products, including the Smart Cycler; and uncertainties related to the timing and success of market introduction and market acceptance of the IDI GBS test.

Readers should refer to the section entitled "Risk Factors" in Cepheid`s Annual Report on Form 10-K for 2001 and "Factors that Might Affect Future Results" in its quarterly reports on Form 10-Q, all of which were 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. The New England Journal of Medicine, Volume 343:175-179, July 20, 2000
2. Schuchat A. Epidemiology of group B streptococcal disease in the United
States: shifting paradigms. Clin Microbiol Rev 1998;11:497-513.

3. Schrag SJ, Zywicki S, Farley MM, et al. Group B streptococcal disease

in the era of intrapartum antibiotic prophylaxis. N Engl J Med

2000; 342:15-20.

4. Krohn MA, Hillier SL, Baker CJ. Maternal peripartum complications

associated with vaginal group B streptococcal colonization. J Infect

Dis 1999;179:1410-1415.

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