SUNNYVALE, Calif., July 26 /PRNewswire-FirstCall/ -- Cepheid , a broad-based molecular diagnostics company, today announced the 510(k) clearance of its first clinical molecular diagnostic product for the Unites States market. Cepheid received 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert GBS(TM) test for Group B Streptococcus (GBS) on its GeneXpert(R) platform.
The Xpert GBS test performed on the GeneXpert Dx System is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from vaginal/rectal swab specimens, using fully automated real-time polymerase chain reaction (PCR) with fluorogenic detection of the amplified DNA. The Xpert GBS Assay testing is indicated for rapid identification of antepartum and intrapartum GBS colonization. The performance characteristics of the Xpert GBS Assay were determined from the evaluation of laboratory testing done on specimens from 791 maternity patients. All subjects had culturing done and most also had a 2nd GBS Nucleic Acid Amplification Test (NAAT) performed. The 2nd NAAT targets a sequence in the cfb gene and was previously FDA-cleared. As compared to culture, the Xpert GBS test demonstrated a sensitivity of 91.9% and specificity of 95.6% for intrapartum specimens and a sensitivity of 85.3% and specificity of 98.1% for antepartum specimens. The 2nd previously cleared GBS NAAT test demonstrated a sensitivity of 81.4% and specificity of 95.6% for intrapartum specimens and a sensitivity of 74.5% and specificity of 97.0% for antepartum specimens.
The Xpert GBS Assay includes unique internal controls to help insure quality of results. A sample-processing control (SPC) monitors processing conditions, an internal control (IC) monitors PCR conditions and the absence of reaction inhibition and a probe check control verifies reagent rehydration, PCR-tube filling in the cartridge, probe integrity, and dye stability.
“As demonstrated by the clinical trial data, the GeneXpert system provides highly accurate results while, at the same time, representing a paradigm shift in automation for molecular diagnostics enabling easy access to molecular diagnostic testing on a 24/7 basis. The system is also expected to enable molecular diagnostic testing to be done on a more broadly disseminated basis than has previously been possible,” said Cepheid Chief Executive Officer John Bishop. “Xpert GBS is the first in a planned menu of Xpert tests scheduled for U.S. release on our GeneXpert(R) platform. The ability to obtain immediately actionable test results is especially critical to the management of expectant mothers with an unknown GBS status for which the GeneXpert System is in a unique position to deliver on this clinical need.”
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.
“A rapid and fully automated molecular test that can be performed on-demand 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.”
“Women are screened for GBS during their antepartum period, between 35 and 37 weeks gestation, but the bacterial population can change quickly. A rapid molecular test would be a tremendous diagnostic asset, particularly for women who receive little to no prenatal care or for those women who deliver preterm,” said Dr. Jeanne Jordan, Ph.D., Associate Professor of Pathology, University of Pittsburgh, and director of the clinical microbiology laboratory at Magee-Womens Hospital of the University of Pittsburgh Medical Center. “Now women could be tested for GBS during the intrapartum period prior to delivery and either receive the necessary treatment or avoid unnecessary antibiotic treatment that can contribute to the development of antibiotic resistant bacterial strains.”
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 from a swab 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 prior to delivery. In addition to providing faster diagnosis, the use of Xpert GBS may help reduce unnecessary antibiotic treatment of women not colonized with the bacteria.
About the GeneXpert System
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 from unprocessed samples.
Representing a major paradigm shift in the automation of molecular diagnostics, the GeneXpert System enables unprecedented speed and ease-of-use in the clinical environment.
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. 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.comjohn.sluis@cepheid.com At Financial Relations Board: At Schwartz Communications: Tricia Ross Chris Stamm / Tom Bain Investor/Analyst Information 415-512-0770 617-520-7064 cepheid@schwartz-pr.comtross@financialrelationsboard.com
Cepheid
CONTACT: John L. Bishop, CEO, john.bishop@cepheid.com, or John R. Sluis,CFO, john.sluis@cepheid.com, both of Cepheid, +1-408-541-4191; orInvestor/Analyst Information, Tricia Ross of Financial Relations Board,+1-617-520-7064, tross@financialrelationsboard.com, for Cepheid; or ChrisStamm, or Tom Bain, both of Schwartz Communications, +1-415-512-0770,cepheid@schwartz-pr.com, for Cepheid
Web site: http://www.cepheid.com/
