SUNNYVALE, Calif., Aug. 22 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD - News), a broad-based molecular diagnostics company, today announced its recently cleared Xpert GBS(TM) test for Group B Streptococcus has now been categorized by the FDA as “moderate complexity” under the Clinical Laboratory Improvement Amendments (CLIA). The Xpert GBS assay is the first amplified molecular diagnostic test utilizing real time polymerase chain reaction (PCR) to receive the moderate complexity CLIA categorization. This will allow the assay to be performed by institutions registered for CLIA Moderate Complexity in addition to institutions registered for High Complexity. Currently, there are over 27,000 laboratories registered as Moderate Complexity in the United States and approximately 7,000 laboratories registered as High Complexity.
“Until now, most clinical molecular diagnostic testing has been limited to institutions that could build and support specialized, sophisticated laboratories and specially trained lab personnel. Although PCR-based technology has been shown to generate relatively fast and highly accurate results, it has remained inaccessible to many of the clinical settings that need it most,” said Cepheid Chief Executive Officer John Bishop. “With the moderate complexity categorization, the Xpert GBS test can be easily performed on-site and on-demand by clinical personnel 24 hours a day, seven days a week.”
“A moderately complex molecular test is a great asset to delivery room personnel,” said Dr. Rodney K. Edwards Assistant Professor at the University of Florida Department of Obstetrics and Gynecology. “Now nurses, physicians or other providers can offer a fast, accurate GBS test at the point of care. GBS can be treated and infection to newborns prevented with proper detection -- a molecular test like Xpert GBS represents a significant advancement in GBS detection that has a direct impact on patient care.”
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. Cepheid’s Xpert GBS test meets American College of Obstetricians and Gynecologists (ACOG) and Centers for Disease Control and Prevention (CDC) guidelines for use in the Prevention of Early-Onset Group B Streptococcal Disease in Newborns.
With more than 4.1 million births in the U.S. subject to infection from GBS, there is a need for highly sensitive molecular diagnostic tests that can be run on-site by delivery room doctors and nurses in order to quickly identify the GBS bacteria in mothers at risk of transferring the bacteria to their babies during delivery. The Xpert GBS test yields results in about an hour where standard culture-based testing may take several days. GBS is easily treated and neonatal transmission prevented when antibiotics are administered to the expectant mother during delivery. In addition to providing faster diagnosis, the use of the Xpert GBS test may help reduce unnecessary antibiotic treatment of women not colonized with the bacteria.
About the GeneXpert System
Representing a major paradigm shift in the automation of molecular diagnostics, the GeneXpert System is the only molecular diagnostic system to combine sample preparation with real time PCR (polymerase chain reaction) amplification, detection functions and internal controls for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences and deliver answers directly from unprocessed clinical specimens.
About Cepheid
Cepheid (Nasdaq: CPHD - News), 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.
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.
CONTACTS:
At the Company:
John L. Bishop John R. Sluis CEO, Cepheid CFO, Cepheid 408-541-4191 408-541-4191 john.bishop@cepheid.com john.sluis@cepheid.com
At Financial Relations Board: At Schwartz Communications:
Lasse Glassen Chris Stamm Investor/Analyst Information 415-512-0770 310-854-8313 cepheid@schwartz-pr.com lglassen@financialrelationsboard.com
Source: Cepheid
