Cepheid Launches CE Mark Certification Smart VZV(TM) in Vitro Diagnostic Test for SmartCycler(R) Platform
Thursday June 1, 7:00 am ET
Real-Time PCR Test for Varicella Zoster-Virus Detection Provides Improved Diagnosis and Patient Treatment
SUNNYVALE, Calif., June 1 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD - News), a broad-based molecular diagnostics company, today announced the European release of the Smart VZV(TM) Assay for clinical diagnostic use on the SmartCycler® System. The VZV assay was released as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. Smart VZV is intended for rapid detection of the varicella-zoster virus, a member of the herpes virus subfamily, the cause of potentially life-threatening complications of the lungs, liver and central nervous system in immunocompromised children. The virus can also cause serious eye, kidney and brain infections also known as retinitis, acute renal necrosis and chronic progressive encephalitis respectively in HIV patients. In addition, VZV the cause of herpes zoster (shingles), may be confused with herpes simplex virus and appropriate laboratory tests are often required for support of the correct diagnosis and subsequent treatment.
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"Multiple data indicate that PCR analysis is more efficient than antigen or antibody testing or viral culture. Now swab specimens obtained from skin and mucosa in addition to cerebrospinal fluid of patients with aseptic meningitis and encephalitis can be used for rapid and sensitive detection of varicella-zoster virus (VZV) via real time PCR," said Professor Jacques Izopet, Head of the Clinical Virology Laboratory, University Hospital of Toulouse. "The results are highly relevant for optimization of specific antiviral therapy for these patients."
"The Smart VZV test is the fourth in a planned menu of CE IVD Mark products scheduled to be released in Europe for use on our SmartCycler and GeneXpert® platforms during 2006 and is the second product in our expanding portfolio for use in the management of immunocompromised patients," said Cepheid Chief Executive Officer John Bishop.
Real-time PCR is a reliable tool for detection of VZV in patients who have developed or are at risk for developing active VZV infection. PCR is especially important in cerebrospinal fluid (CSF) samples where standard viral culture procedures are relatively insensitive. The Smart VZV Assay offers a standardized qualitative method that can be used for the detection of VZV DNA in vesicle swabs and CSF samples. The assay offers a highly sensitive limit of detection. The use of an internal control greatly minimizes the risk of false negative results.
Cepheid's Smart VZV delivers a positive or negative result in under an hour after DNA extraction, a dramatic improvement over the days required to derive a result with traditional culture-based tests.
The SmartCycler® System is a leading real-time PCR testing platform for hospitals, university labs and government agencies. By automating the amplification and detection process, the SmartCycler® System can deliver highly accurate and consistent test results from prepared biological samples in 30-40 minutes. With up to 96 independently programmable reaction sites, the SmartCycler can simultaneously run multiple experiments with different protocols and at different 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 (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 timing of product shipments and expansion in the clinical diagnostics 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: development and manufacturing problems; our ability to successfully obtain regulatory approvals and introduce new products in the clinical market; customer 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; 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:
Tricia Ross Chris Stamm / Tom Bain
Investor/Analyst Information 781-684-0770
617-520-7064 cepheid@schwartz-pr.com
