Navigation Links
Cepheid Extends Rapid Molecular Diagnostics' Leadership with FDA Clearance of Xpert Clostridium difficile/Epi
Date:4/11/2011

SUNNYVALE, Calif., April 11, 2011 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Xpert® C. difficile/Epi test. Cepheid's first Xpert C. difficile test has been available in the United States since July 2009. The test's unique combination of high sensitivity and rapid turnaround time has quickly established Xpert C. difficile as the molecular market leader. Building on the success of Xpert C. difficile, which detects the bacterium that causes C. difficile infection (CDI), Xpert C. difficile/Epi additionally and simultaneously identifies the epidemic strain of C. difficile, also known as 027, NAP1 or BI.

"Compared to less virulent strains, C. difficile 027 strains produce higher levels of spores which pose greater infection control challenges," said John Bishop, Cepheid's Chief Executive Officer.  "Additionally, there is a growing body of evidence that the 027 strain is associated with more frequent relapses and ultimately higher mortality rates. The 027 differentiation is therefore a welcome addition to Cepheid's Xpert test portfolio."

Among C. difficile cases, the prevalence of the epidemic 027 strain is increasing(1). Although the Xpert C. difficile/Epi test is not intended to guide specific patient treatment decisions, it will identify those patients infected with the epidemic strain and therefore at greater risk.

"We believe that detection of the 027 strain provides important epidemiologic information, particularly for institutions facing an outbreak of CDI, and Cepheid is very pleased to be the first to offer a test that specifically identifies the 027 strain with the accuracy, speed, and ease-of-use that our customers have come to expect from the Xpert family of tests," said David Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "The use of Cepheid's special nucleic acid chemistry capability was critical to achieving the required performance levels of this sophisticated next-generation test, which targets two toxin genes and a regulatory point mutation."

The Xpert C. difficile/Epi test, which runs on the GeneXpert® system, is Cepheid's tenth Xpert test to receive FDA clearance. It is expected to be available for shipment the week of May 16.

About CepheidBased in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.

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, future products 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 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, 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 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.

References

(1) - Louie T, Miller M, Mullane K, et al.  Fidaxomicin versus Vancomycin for Clostridium difficile Infection.  N Engl J Med 2011 ; 364 :422-31CONTACTS:For Media Inquiries:For Cepheid Investor Inquiries:Jared Tipton

Cepheid Corporate Communications

408-400-8377

communications@cepheid.com

Jacquie Ross

Cepheid Investor Relations

408-400-8329

investor.relations@cepheid.com
'/>"/>

SOURCE Cepheid
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Cepheid Announces Termination of Contract With the Centers for Disease Control and Prevention to Develop Rapid Point of Care Test for Avian Influenza
2. Cepheid Launches New GeneXpert(R) Tests in Europe for Simultaneous, Rapid Detection of Staphylococcus Aureus and Methicillin Resistant Staphylococcus Aureus
3. Cepheid GeneXpert(R) System and Xpert(TM) MRSA Selected for up to 11 Victoria, Australia Hospitals in Rollout of Start Clean Strategy
4. Cepheid Announces CE IVD Release of First On-Demand Test for van A/van B Genes Most Associated With Hospital-Acquired VRE Infection
5. Cepheid Molecular Diagnostic Test for Positive Blood Culture Bottles Categorized Moderate Complexity by FDA
6. Cepheid Announces European Release of First On-Demand Molecular Test for Simultaneous Detection of Mycobacterium tuberculosis (TB) and Resistance to Rifampicin
7. Cepheid Receives Grant to Develop Ten-Color Real-Time PCR Detection Technology for Use in the GeneXpert(R) System
8. Cepheid Reports 2009 Third Quarter Results
9. Cepheid to Webcast Upcoming Financial Presentations
10. Cepheid Collaborates With Pharmaceutical Leader on Chronic Myelogenous Leukemia
11. Cepheid to Webcast Upcoming Financial Presentation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... Research and Markets has announced the addition of the ... to their offering. ... World Market for Companion Diagnostics covers the world market for ... report includes the following: , World IVD ... (N. America, EU, ROW), 2015-2020 , World IVD Companion ...
(Date:6/24/2016)...  Arkis BioSciences, a leading innovator in the ... cerebrospinal fluid treatments, today announced it has secured ... led by Innova Memphis, followed by Angel Capital ... Arkis, new financing will accelerate the commercialization of ... of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... , June 23, 2016 ... "Pharmaceutical Excipients Market by Type (Organic Chemical (Sugar, ... Formulation (Oral, Topical, Coating, Parenteral) - Global Forecast to ... The global pharmaceutical excipients market ... at a CAGR of 6.1% in the forecast period ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... ... Bruton Memorial Library on June 21 due to a possible lice infestation, as reported by ... lice: the parasite’s ability to live away from a human host, and to infest common ... the event that lice have simply gotten out of control. , As lice are a ...
(Date:6/25/2016)... ... 2016 , ... On Friday, June 10, Van Mitchell, Secretary of the Maryland ... iHire in recognition of their exemplary accomplishments in worksite health promotion. , The Wellness ... & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one of ...
(Date:6/24/2016)... ... ... Marcy was in a crisis. Her son James, eight, was out of control. Prone to ... , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there ... my other children and say he was going to kill them. If we were ...
(Date:6/24/2016)... ... 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join ... wage raise to $12 an hour by 2020 and then adjusting it yearly to increase ... of the minimum wage, assure the wage floor does not erode again, and make future ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... actively feeding the Frederick area economy by obtaining investment capital for emerging technology ... past 2½ years that have already resulted in more than a million dollars ...
Breaking Medicine News(10 mins):