SUNNYVALE, Calif., Dec. 11 /PRNewswire-FirstCall/ -- Cepheid , a broad-based molecular diagnostics company, today announced it received 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market its Smart GBS test for Group B Streptococcus (GBS) on its SmartCycler platform. Smart GBS is intended for rapid detection of GBS colonization in pregnant women.
This is the second in vitro diagnostic GBS test from Cepheid, providing a complete molecular GBS testing portfolio to health care institutions. Smart GBS delivers multiple testing solutions, with protocols for testing direct from swabs in both the antepartum and intrapartum setting or for higher sensitivity with a Lim broth pre-enrichment protocol utilized in the antepartum testing application. The Smart GBS compliments the Xpert GBS test, which received 510(k) clearance in July, providing an industry-first 'moderate complexity' designation and GeneXpert technology to deliver one-hour results 24/7 -- especially ideal for intrapartum testing.
"The option of having an FDA-cleared Lim Broth Pre-Enrichment protocol for antepartum GBS testing is a great asset to pathology labs like ours," said Jeanne A. Jordan, Ph.D., Associate Professor of Pathology, University of Pittsburgh School of Medicine and one of the Smart GBS clinical investigators(1). "We currently use the Lim Broth protocol when screening our antepartum patients for GBS colonization, but Smart GBS will make it easier to incorporate into our procedures. As a result, we will have a test that is more sensitive and easier to use."
"Together with Cepheid's Xpert GBS test, which received 510(k) clearance in July of 2006 for use on our fully-automated GeneXpert System, healthcare organizations now have a comprehensive, highly accurate suite of molecular GBS tests for 24/7 antepartum and intrapartum use," said Cepheid Chief Executive Officer John Bishop. "Smart GBS is the second in a planned menu of in vitro diagnostic products for the U.S. market, designed to provide clinicians with rapid, actionable results for improved patient management."
According to the U.S. Centers for Disease Control (CDC), GBS bacterium is the most common cause of life-threatening infections in newborns and is the leading infectious cause of neonatal morbidity and mortality. Untreated, GBS can cause the development of sepsis, pneumonia, and meningitis -- leading to sight or hearing loss, mental retardation or death. GBS related sepsis and meningitis in newborns results in a 4% fatality rate of those infected. Treatment of infected mothers and infants cost the healthcare system approximately $300 million each year.
As a result, the CDC and the American College of Obstetricians and Gynecologists (ACOG) recommend that all pregnant women be tested for their GBS status. It can be used instead of the existing standard of care, culture-based GBS testing, which takes two to three days to generate a result. Results from Cepheid's Smart GBS test can help to ensure the proper treatment of GBS colonized women, and may reduce unnecessary antibiotic use in women not colonized with the bacterium, which can lead to the development of drug-resistant GBS.
About the SmartCycler System
The SmartCycler System is a leading real-time PCR testing platform for hospitals, university research labs and government agencies. By automating the amplification and detection process, the SmartCycler System can deliver highly accurate and consistent Smart GBS test results. With 16 independently programmable reaction sites, expandable up to 96, the SmartCycler System can simultaneously run multiple tests with different protocols and start times. This eliminates complex advanced scheduling on larger, more costly systems, as well as the need to transport samples to central facilities for analysis.
About Cepheid
Cepheid , 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. Through its broad 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.
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 usage in the clinical diagnostics market and future products for the clinical market. 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 development and manufacturing problems; our ability to successfully obtain regulatory approvals for additional products and to introduce new products in the clinical market; customer market acceptance of new products; the failure of products to perform as expected, whether due to manufacturing errors, defects or otherwise; the impact of competitive products and pricing; potentially lengthy sales cycles in some markets; reimbursement rates for the products; 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 2005 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.
(1) Dr. Jordan was paid an honorarium for her work investigating Smart GBS. CONTACTS: At the Company: John L. Bishop John R. Sluis CEO, Cepheid CFO, Cepheid 408-541-4191 408-541-4191 john.bishop@cepheid.comjohn.sluis@cepheid.com At Financial Relations Board: At Schwartz Communications: Tricia Ross Chris Stamm Investor/Analyst Information 415-512-0770 310-854-8318 cepheid@schwartz-pr.comtross@financialrelationsboard.com
CepheidCONTACT: John L. Bishop, CEO, john.bishop@cepheid.com, or John R. Sluis,CFO, john.sluis@cepheid.com, both of Cepheid, +1-408-541-4191; orInvestors/Analysts, Tricia Ross of Financial Relations Board,+1-310-854-8318, tross@financialrelationsboard.com, for Cepheid; or ChrisStamm of Schwartz Communications, +1-415-512-0770, cepheid@schwartz-pr.com,for Cepheid
Web site: http://www.cepheid.com/
