Navigation Links
BD Announces FDA 510(K) Submission of Rapid Molecular Test to Identify Patients Carrying Staph Superbug Prior to Surgery
Date:9/11/2007

First Molecular Test to Simultaneously Identify Staphylococcus Aureus and

Methicillin-Resistant Staphylococcus Aureus from Nasal Specimens

SAN DIEGO, Sept. 11 /PRNewswire-FirstCall/ -- BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), announced today that it has made a 510(k) submission to the U.S. Food and Drug Administration (FDA), for additional claims for the BD GeneOhmTM StaphSR assay. This will be the first assay for rapid and simultaneous identification of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) from patients colonized in the nasal passage.

The BD GeneOhm StaphSR assay is a simple test that provides results within two hours directly from nasal swabs. The assay is easy to perform and requires less technologist time than traditional microbiology algorithms, which can take two days to generate results.

Identifying patients colonized with MRSA or SA bacteria in advance of surgery helps ensure patients have an opportunity to be decolonized and receive the appropriate prophylactic antibiotics prior to surgery. This reduces the risk of a potentially deadly surgical site infection (SSI).

A recent study revealed that patients acquiring SSIs after coronary artery bypass graft (CABG) surgery had a one year mortality rate of 22 percent. This study also found that lengths of stay and costs increased by 20 days and $18,938, respectively, for this patient population.

Since the most frequent organism cultured in cardiac SSIs is Staphylococcus sp., and colonization is considered the major factor in wound contamination, the Society of Thoracic Surgeons issued guidelines recommending rapid PCR screening tests for Staphylococcus aureus colonization prior to surgery. For patients positive for Staphylococcus sp., decolonization with the antibiotic ointment mupirocin is recommended as a routine measure. In addition, a patient's colonization status is an important indicator in determining the appropriate prophylactic antibiotic to administer one hour prior to surgery.

About BD

BD, a leading global medical technology company that manufactures and sells medical devices, instrument systems and reagents, is dedicated to improving people's health throughout the world. BD is focused on improving drug therapy, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. The Company's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 27,000 people in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. For more information, please visit http://www.bd.com.

This press release contains certain forward-looking statements (as defined under Federal securities laws) regarding BD's performance, including future products or other events or developments that BD expects to occur or anticipates occurring in the future. All such statements are based upon current expectations of BD and involve a number of business risks and uncertainties. Actual results could vary materially from anticipated results described, implied or projected in any forward-looking statement. Factors that could cause actual results to vary materially from any forward-looking statement include, but are not limited to: competitive factors; pricing and market share pressures; difficulties inherent in product development and delays in product introductions; changes in regional, national or foreign economic conditions; increases in energy costs and their effect on, among other things, the cost of producing BD's products; fluctuations in costs and availability of raw materials and in BD's ability to maintain favorable supplier arrangements and relationships; uncertainties of litigation (as described in BD's filings with the Securities and Exchange Commission), changes in healthcare or other governmental regulation; as well as other factors discussed in BD's filings with the Securities and Exchange Commission. We do not intend to update any forward-looking statements to reflect events or circumstances after the date hereof except as required by applicable laws or regulations.


'/>"/>
SOURCE BD Diagnostics
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
2. Sygnis Pharma AG announces date for presentation of clinical results
3. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
4. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
5. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
6. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
7. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
8. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
9. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
10. Protox Announces Positive Clinical Data from Prostate Cancer Study
11. Inspire Announces Webcast of Presentation at C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... , Dec. 8, 2016 Australia Glaucoma ... GlobalData,s new report, "Australia Glaucoma Surgery Devices ... on the Australia Glaucoma Surgery Devices market. The ... volume (in units) and average prices (USD) within ... report also provides company shares and distribution shares ...
(Date:12/8/2016)... , Dec. 8, 2016 KEY FINDINGS ... poised to grow in 2017-2023. Various reasons for growth ... obese population, higher incidences of chronic diseases, high recovery ... mobility aid services. Medical lifting sling refers to ... with limited mobility. These slings connect to the lift ...
(Date:12/8/2016)... INDIANAPOLIS , Dec. 8, 2016  Eli Lilly ... detailed results of its phase 3 EXPEDITION3 trial at ... (CTAD) meeting. As previously disclosed, solanezumab did not meet ... study of solanezumab initiated in people with mild dementia ... pursue regulatory submissions for solanezumab for the treatment of ...
Breaking Medicine Technology:
(Date:12/9/2016)... ... 2016 , ... The Pennsylvania Athletic Trainers’ Society (PATS) aired ... of 2016. The program was made possible by a Pennsylvania Department of Health ... and Human Services Administration. The broadcast, Use Your Head: Properly Managing Sport ...
(Date:12/8/2016)... Islandia, NY (PRWEB) , ... December 08, 2016 ... ... company, is pleased to announce that “Natural Language Processing–Enabled and Conventional Data Capture ... published in JMIR Medical Informatics . , Results of the comparative usability ...
(Date:12/8/2016)... ... ... David J. Dykeman , Ginger Pigott , and J. Rick ... West, Dec. 12, 2016, at the Fairmont Newport Beach in California. Greenberg Traurig is ... Sciences & Medical Technology Group have been featured speakers at every DeviceTalks conference since ...
(Date:12/8/2016)... , ... December 08, 2016 , ... ... Center has been recognized for adherence to the highest standards of trauma, ... accreditation organizations, announced the center's president and CEO, Dr. Daniel Messina. , Among ...
(Date:12/8/2016)... ... 2016 , ... Vida Health, the digital health platform that pairs ... Canvas Ventures . Other investors include Nokia Growth Partners (NGP) and returning investor Aspect ... consumers who are managing chronic conditions or simply want to improve their ...
Breaking Medicine News(10 mins):