Navigation Links
Cepheid Molecular Diagnostic Test for Positive Blood Culture Bottles Categorized 'Moderate Complexity' by FDA
Date:11/4/2008

Fourth 'Moderate Complexity' Categorization Highlights GeneXpert(R) System

Ease-of-Use

SUNNYVALE, Calif., Nov. 4 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD) today announced the U.S. Food & Drug Administration (FDA) categorized Cepheid's Xpert(TM) MRSA/SA Blood Culture (BC) test as "Moderate Complexity" under the Clinical Laboratory Improvement Amendments (CLIA). The new test is designed for on-demand detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA), (typically Methicillin-sensitive) in positive patient blood culture bottles.

Cleared by the FDA for marketing last month, Xpert MRSA/SA BC is the first molecular diagnostic test for positive blood culture bottles to receive the moderate complexity CLIA categorization. The test runs on Cepheid's GeneXpert(R) System, the leading platform for on-demand detection of Healthcare Acquired Infections (HAIs).

"Cepheid is providing institutions with the most comprehensive product portfolio for rapid detection of MRSA and SA -- all of which are now categorized 'Moderate Complexity' by the FDA," said Cepheid Chief Executive Officer John Bishop. "The GeneXpert System is unparalleled in its ability to combine the benefits of molecular testing with on-demand availability. With 'Moderate Complexity' categorization, Xpert MRSA/SA BC can now be run 24/7."

Xpert MRSA/SA BC processes positive blood culture specimens to determine if a patient's blood is infected with MRSA or SA, which are frequent causes of sepsis in hospitalized patients. This may enable physicians to quickly de-escalate from broad-spectrum antibiotic treatment to a more effective targeted therapy, thus reducing risk of resistance and improving patient outcomes.

Typically, physicians will order a set of blood culture bottles drawn from patients presenting with symptoms of systemic infections. While positive cultures can appear in as little as 6-24 hour
'/>"/>

SOURCE Cepheid
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

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. BD Announces FDA 510(K) Submission of Rapid Molecular Test to Identify Patients Carrying Staph Superbug Prior to Surgery
6. Preclinical Data on Lead MEK Inhibitor, RDEA119, to be Presented at the 2007 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
7. Access Pharmaceuticals to Present Data on ProLindac(TM) at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference
8. Abbotts m2000(TM) Molecular Diagnostic Instrument and RealTime HIV-1 Test Win Chicago Innovation Award
9. Tapestry Pharmaceuticals Presents Data on TPI 287 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
10. Access Pharmaceuticals Announces Two Poster Presentations Reporting Significant Preclinical Data on ProLindac(TM) at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference
11. Study Shows That Low-Molecular Weight Heparin (LMWH) was Associated with Reduced Hospital Costs of Venous Thromboembolism (VTE) Treatment Compared with Unfractionated Heparin (UFH)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... , Jan. 15, 2014 Most osteoporosis patients want ... a recent online survey* sponsored by Mission Pharmacal Company. ... National Osteoporosis Foundation online support community, revealed that 74 ... that comes in a form other than a pill ...
(Date:1/15/2014)... , Jan. 15, 2014 AARP Foundation today announced ... older adults suffering from the severe cold weather that has ... committed to helping those in need; so to support these ... contributions up to $250,000, which could mean up to $500,000 ...
(Date:1/15/2014)... Jan. 15, 2014 Massachusetts General Hospital (MGH), ... AMGN ) announced today that they have launched ... new therapeutic targets and develop novel therapies for ... affects millions worldwide. The MGH-Broad-Amgen collaboration brings together ...
Breaking Medicine Technology:Mission Pharmacal Conducts Online Survey of Osteoporosis Patients 2Mission Pharmacal Conducts Online Survey of Osteoporosis Patients 3AARP Foundation Establishes Winter Relief Fund for Older Adults Suffering from the Severe Cold Weather 2AARP Foundation Establishes Winter Relief Fund for Older Adults Suffering from the Severe Cold Weather 3Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 2Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 3Mass. General, Broad Institute and Amgen Will Work to Discover New Drugs for Inflammatory Bowel Disease 4
... a leading Clinical Research Organization, announces it is ... World (ECDW), 13-14 May 2009, in London, UK. ... and most highly regarded early development congress. Experts ... be available to discuss PRA,s capabilities at ECDW. ...
... 11 Arno Therapeutics, Inc., a clinical-stage biopharmaceutical ... the U.S. Food and Drug Administration ("FDA") accepted ... the use of AR-12, a potentially first-in-class, orally ... and induces the endoplasmic reticulum stress pathway. ...
Cached Medicine Technology:PRA International: Participating Sponsor for Exploratory Clinical Development World in London 2FDA Accepts Arno Therapeutics' IND for AR-12 a PDK1 Inhibitor That Blocks the PI3K/Akt Pathway 2FDA Accepts Arno Therapeutics' IND for AR-12 a PDK1 Inhibitor That Blocks the PI3K/Akt Pathway 3
(Date:7/13/2014)... A Xarelto lawsuit webpage has been launched ... with the most current information regarding serious internal bleeding ... as well as the growing number of Xarelto ... The law firm is now offering free legal evaluations ... bleeding and related complications while using Xarelto, including:, ...
(Date:7/13/2014)... 2014 According to The Peripheral Neuropathy ... comprehensive program that teaches people how to deal with ... without medications. This program also provides people with safe ... neuropathy , including numbness, prickling, burning, and intense stabbing ... this home treatment program can help people eliminate some ...
(Date:7/12/2014)... 2014 Recently, iFitDress.com, one of the world’s ... red evening gowns . What’s more, all these hot ... , The company’s senior spokesman states, “We are proud to ... website is an enjoyable shopping experience. In addition to the ... store, low prices do not always mean bad quality. All ...
(Date:7/12/2014)... report, "Phthalic Anhydride and Derivatives (Plasticizers, Unsaturated Polyester Resins, ... Trends & Forecast to 2018," defines and segments phthalic ... and value. The report also estimates the demand and ... anhydride is projected to grow from an estimated $6,130.55 ... a CAGR of 5.24% from 2013 to 2018. , ...
(Date:7/12/2014)... July 12, 2014 The Security Analytics ... 2013 to $3,376.6 million by 2019, at an expected ... 2019. The challenges to counter the increasing number of ... of outdated cyber defense systems in organizations are enormous. ... and remodeling their existing architecture to develop better and ...
Breaking Medicine News(10 mins):Health News:Xeralto Lawsuit Page Launched By Wright & Schulte LLC To Provide Information On Potential For Xarelto Bleeding Side Effects, Growing Litigation 2Health News:Xeralto Lawsuit Page Launched By Wright & Schulte LLC To Provide Information On Potential For Xarelto Bleeding Side Effects, Growing Litigation 3Health News:Xeralto Lawsuit Page Launched By Wright & Schulte LLC To Provide Information On Potential For Xarelto Bleeding Side Effects, Growing Litigation 4Health News:The Peripheral Neuropathy Program Review Exposes Randall Labrum's Peripheral Neuropathy Treatment Program – Vkool.com 2Health News:The Peripheral Neuropathy Program Review Exposes Randall Labrum's Peripheral Neuropathy Treatment Program – Vkool.com 3Health News:Discounted Red Evening Gown Announced by iFitDress.com 2Health News:Phthalic Anhydride Market Projected to Reach $8.42 Billion by 2018 – Report by MarketsandMarkets 2Health News:Phthalic Anhydride Market Projected to Reach $8.42 Billion by 2018 – Report by MarketsandMarkets 3Health News:Phthalic Anhydride Market Projected to Reach $8.42 Billion by 2018 – Report by MarketsandMarkets 4Health News:North America Security Analytics Market Worth $1,215.2 Million by 2019 - New Report by MicroMarket Monitor 2Health News:North America Security Analytics Market Worth $1,215.2 Million by 2019 - New Report by MicroMarket Monitor 3Health News:North America Security Analytics Market Worth $1,215.2 Million by 2019 - New Report by MicroMarket Monitor 4
... Stiefel Laboratories, Inc.,("Stiefel Laboratories"), the world,s ... today that the waiting,period under the Hart-Scott-Rodino ... Act") has expired, for its proposed acquisition ... BTRX )., As previously announced, Stiefel ...
... of Adelaide have developed a novel approach to treating ... fewer side effects. , Professor Wayne Tilley and Dr ... Research Laboratories have discovered that by using existing prostate ... doses, they can expect to generate better results for ...
... smoking spouse quits , , TUESDAY, July 29 (HealthDay News) -- ... risk for experiencing a stroke, a new study suggests. , ... who still smoke carry an even greater risk for stroke. ... bear any higher risk for stroke than those married to ...
... Southern Home Medical,Equipment, Inc. (OTC: SHOM) announced today ... solid growth. Industry statistics,suggest a very favorable market ... from the U.S. Bureau of Labor Statistics published ... one million new and,replacement nurses will be needed ...
... for Excellence Issue Brief, WASHINGTON, July 29 ... has issued its second issue brief on retiree,health ... Estimates,of Liabilities. The brief, which was written by ... and entrepreneurship in the,College of Management, North Carolina ...
... single women identify any gaps in coverage or inadequate protection ... ... 2008 -- http://www.combinedinsurance.com/ [Combined Insurance], a leading provider ... 27-August 2, 2008, sponsored by SWWAN® (Single Working Women,s Affiliate ...
Cached Medicine News:Health News:Stiefel Laboratories, Inc. Announces Expiration of Hart-Scott-Rodino Waiting Period Relating to its Proposal to Acquire Barrier Therapeutics, Inc. 2Health News:Stiefel Laboratories, Inc. Announces Expiration of Hart-Scott-Rodino Waiting Period Relating to its Proposal to Acquire Barrier Therapeutics, Inc. 3Health News:Stiefel Laboratories, Inc. Announces Expiration of Hart-Scott-Rodino Waiting Period Relating to its Proposal to Acquire Barrier Therapeutics, Inc. 4Health News:New treatment for advanced prostate cancer 2Health News:Secondhand Smoke Raises Stroke Risk for Spouses 2Health News:Secondhand Smoke Raises Stroke Risk for Spouses 3Health News:Southern Home Medical's Encore Medical Staffing Division Poised to Benefit from Major Growth in Nursing Industry 2Health News:Financing Retiree Health Care: Assessing GASB 45 Estimates of Liabilities 2Health News:Combined Insurance Reports that Single Working Women's Week is a Good Time for Annual Review of Insurance Coverage 2Health News:Combined Insurance Reports that Single Working Women's Week is a Good Time for Annual Review of Insurance Coverage 3Health News:Combined Insurance Reports that Single Working Women's Week is a Good Time for Annual Review of Insurance Coverage 4Health News:Combined Insurance Reports that Single Working Women's Week is a Good Time for Annual Review of Insurance Coverage 5
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: