Healthcare Industry News: H1N1
News Release - January 4, 2010
Cepheid Receives FDA Emergency Use Authorization (EUA) for First 2009 H1N1 Influenza Assay for CLIA 'Moderate Complexity' LaboratoriesXpert(R) Flu A Panel Identifies the 2009 H1N1 Influenza Virus in Less Than One Hour
SUNNYVALE, Calif., Jan. 4 (Healthcare Sales & Marketing Network) -- Cepheid (Nasdaq: CPHD) today announced it has been granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Xpert® Flu A Panel test. The test, which runs on Cepheid's GeneXpert® System, identifies the 2009 H1N1 influenza virus in less than one hour. The FDA has authorized Cepheid's Xpert Flu A Panel to be used in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform "moderate complexity" (not waived) testing, enabling the test to be performed in hospital near-patient settings.
"Accuracy combined with ease-of-use and the broad testing applicability of the GeneXpert® System offers a helpful unique diagnostic solution in helping to address this healthcare issue," said John Bishop, Cepheid's Chief Executive Officer. "Although PCR testing is now recognized as the new gold standard for detection of influenza virus infection, test availability for 2009 H1N1 has so far been limited to high-complexity laboratories and results are not typically available around the clock. Xpert Flu A Panel combines the convenience and ease-of-use of rapid testing with the performance of PCR, in a test format that maximizes medical value by providing results when they are most needed."
2009 H1N1 is a new influenza virus that was detected in the United States in April 2009. As such, children and younger adults are less likely than older people to have immunity to this virus, and illness may be more severe and widespread as a result.(1) In June 2009, the World Health Organization (WHO) announced the spread of the novel 2009 H1N1 virus had reached pandemic phase 6, the highest level of pandemic alert designated by the organization.(2)
"So far, 2009 H1N1 appears to be the predominant influenza strain this season," said Dr. Preveen Ramamoorthy, director of molecular diagnostics at National Jewish Health in Denver CO. "An easy-to-use, rapid PCR-based 2009 H1N1 test can assist clinicians in making real-time medical decisions that help hospitals significantly improve their patient management."
Cepheid will continue development of an expanded influenza panel product that it expects to test for Influenza A with strain identification for H1 seasonal and H3 seasonal influenza A subtypes, the 2009 H1N1 subtype, and Influenza B. For that product, Cepheid expects to submit a separate 510(k) in 2010.
Cepheid expects Xpert Flu A Panel to become available in Europe as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices the week of December 28, 2009. Visit www.cepheidinternational.com for Cepheid's complete CE IVD menu of Xpert tests.
About the FDA's Emergency Use Authorization
The US Secretary of Health and Human Services has declared a public health emergency because of the outbreak of the pandemic flu virus. The FDA has issued emergency use authorizations to make diagnostic and therapeutic tools available to public health and medical personnel for use in the diagnosis of 2009 H1N1 influenza virus under certain circumstances.
The FDA has not cleared or approved any tests for the identification of the 2009 H1N1 influenza virus. The emergency use authorization authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved and uncleared medical products following a determination and declaration of emergency, provided certain criteria are met. The FDA can only grant emergency use authorization for the duration of the emergency, which is currently set to expire on April 26, 2010, unless it is terminated sooner or renewed. The FDA may also revoke an EUA prior to the termination of the emergency.
About the GeneXpert System
The GeneXpert System is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. The GeneXpert System is the only authorized system to combine on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples. Modular in design, the GeneXpert System has a variety of configurations to meet the broad range of testing demands of any clinical environment.
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is an on-demand molecular diagnostics company that develops, manufactures, and markets fully-integrated systems and tests 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. 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 the timing of new product releases, regulatory developments and approval and product performance. 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 product development and manufacturing problems; uncertainties in the regulatory review process for new products; regulatory developments and practices regarding testing; the lack of assurance as to the duration of the emergency authorization; customer and market acceptance of the product; the failure of the product to perform as expected, whether due to manufacturing errors, design defects or otherwise; the impact of competitive products and pricing; potentially lengthy sales cycles in some markets; reimbursement rates for the product; 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 2008 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.
- CDC: Facts About Novel H1N1 Influenza; May 2009
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