Navigation Links
Cepheid Announces Accelerated Development of Flu A Panel Test
Date:9/9/2009

SUNNYVALE, Calif., Sept. 9 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD) today announced the accelerated development of a Flu A (Influenza Virus) Panel test for use on the GeneXpert((R)) System. The test will be designed to provide 45-minute identification of Flu A infection, with specific presumptive identification of seasonal H1, seasonal H3, and H1N1 novel strain types. Following review of the Request for Consideration for Emergency Use Authorization (EUA) by the U.S. Food & Drug Administration (FDA), the test is expected to be authorized for use during the upcoming influenza season, with product shipments beginning in January 2010.

"In reviewing the needs of the healthcare system, it became apparent that the GeneXpert is a key potential solution to the universal need for rapid and accurate flu testing on both a centralized and disseminated basis," said John Bishop, Cepheid's Chief Executive Officer. "In recognition of this universal need, we reprioritized longer term projects within the company in order to deliver this product in a timely manner."

Subsequent to the EUA request for consideration by the FDA, the test will be made available in Europe as a CE IVD product.

"Currently, laboratories do not have a rapid test to discriminate among the multiple influenza strains expected to be present this flu season -- each of which have different antiviral drug susceptibilities," said David Persing, MD, PhD, Cepheid's Executive Vice President, Chief Medical & Technology Officer. "To make this test available as quickly as possible, we plan to accelerate development by leveraging the work completed on a previous influenza project supported through a 2007 contract with the Department of Health and Human Services (HHS) and Centers for Disease Control and Prevention (CDC)."

Following EUA request to the FDA, development of Cepheid's Flu Panel test will continue by adding additional target identification for Flu B. For that product, a separate 510(k) submission is expected in 2010.

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 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.

About Cepheid

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, the timing and likelihood of regulatory review and approval, product performance, and future market opportunities. 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; 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.

    CONTACTS:
    For Media Inquiries:                       For Cepheid Investor Inquiries:
    Jared Tipton                               Jacquie Ross
    Cepheid Corporate Communications           Cepheid Investor Relations
    408-400-8377                               408-400-8329
    jared.tipton@cepheid.com                   investor.relations@cepheid.com


'/>"/>
SOURCE Cepheid
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Cepheid to Webcast Upcoming Financial Presentations
2. Cepheid Reports 2009 Second Quarter Results
3. Cepheid Receives FDA Clearance for First On-Demand Molecular Diagnostic Test for Clostridium difficile Infection
4. Cepheid Announces European Release of Improved Test for BCR-ABL Chromosomal Translocation Associated With Chronic Myelogenous Leukemia (CML)
5. Cepheid Announces Symposium Program for 2009 Association for Professionals in Infection Control (APIC) Annual Conference
6. Cepheid Receives Health Canada License for Xpert(R) HemosIL(R) FII & FV Test
7. Blue Mountain Quality Resources Announces that Cepheid has Selected Blue Mountain Regulatory Asset Manager
8. Cepheid to Webcast Upcoming Financial Presentations
9. Cepheid Announces European Release of First On-Demand Molecular Pre-Surgical Screening Test for Simultaneous Detection of Methicillin-Sensitive and Resistant S. aureus
10. Cepheid Receives Health Canada License for First On-demand Diagnostic Test for Life-threatening MRSA and S. aureus Infections From Patient Positive Blood Culture Bottles
11. Cepheid Reports Fourth Quarter and Full Year 2008 Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2017)... ... April 28, 2017 , ... ... the North East region. Côté has 20+ years of experience within the beauty ... Côté worked with an array of high-end cosmetic brands, retail brands and outlets ...
(Date:4/28/2017)... ... April 28, 2017 , ... Semrock’s highly popular SearchLight ... online modeling resource for fluorescence microscopists and optical system designers, enabling The Right ... years spanning the globe, SearchLight has become a tremendously popular tool for the ...
(Date:4/27/2017)... ... April 27, 2017 , ... ... deodorant. On the heels of Thinksport’s award-winning sunscreen they’ve used the same scientific ... actually works! , Countless deodorants flood the aisles that contain harmful chemicals that ...
(Date:4/27/2017)... ... April 27, 2017 , ... Offering the purest product ... oil many times purer and more potent than the market has seen before. Swissx ... Switzerland, as well as a patented chromatography process for extraction, to produce its CBD ...
(Date:4/26/2017)... ... April 26, 2017 , ... Journal of Oral Implantology ... have severe consequences to overall dental health, including complications with speech, eating, and overcompensation ... dental implants to replace lost teeth. As the number of tooth replacements increase, it ...
Breaking Medicine News(10 mins):
(Date:4/19/2017)... April 19, 2017 The Mobile X-Ray product segment ... healthy CAGR during the forecast period Mobile X-Ray ... global digital mobile X-Ray devices market, which is estimated to ... expanding at a CAGR of 7% over the forecast period. ... of more than US$ 100 Mn in 2017 over 2016. ...
(Date:4/19/2017)... , April 19, 2017 Global ... This report on the prostate cancer therapeutics market ... global market. Increasing prevalence of prostate cancer, launch ... in the development of new drugs & therapeutic ... cancer drug due to lesser side effects are ...
(Date:4/19/2017)... April 19, 2017  Sorrento Therapeutics, Inc. (NASDAQ: ... biopharmaceutical company developing new treatments for cancer and ... of its previously announced underwritten public offering of ... public offering price of $2.00 per share, before ... expenses payable by Sorrento.  The net proceeds to ...
Breaking Medicine Technology: