Navigation Links
BD Supports the FDA's Proposal to Reclassify Rapid Influenza Tests
Date:8/26/2013

FRANKLIN LAKES, N.J., Aug. 26, 2013 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, supports the U.S. Food and Drug Administration's (FDA's) proposed reclassification of rapid influenza detection tests.  A hearing, held on June 13th by FDA's CDRH Microbiology Devices Advisory Committee Meeting, examined the FDA's proposal to reclassify rapid influenza detection tests (RIDTs) currently regulated as Class I devices, into Class II devices.

The recent 2009 flu pandemic has emphasized the poor performance of point-of-care flu tests available at the time. The new performance standards will provide healthcare providers with criteria for evaluating the tests that they use. The proposal would increase performance requirements for RIDTs to attain at least a sensitivity of 90 percent for influenza A and 80 percent for influenza B versus viral culture and/or 80 percent versus polymerase chain reaction (PCR) methods. If these minimum clinical performance criteria are not met, marketed devices will need to be withdrawn from the market one year after the rule is finalized. This proposal culminates years of publications showing that many of the visual read RIDTs had poor sensitivity when compared to viral culture and to reverse transcription PCR methods.

"This proposal is a step in the right direction as physicians and hospitals routinely rely on rapid diagnostic influenza tests to help manage patients that are suspected of having influenza," said Tom Polen, President, BD Diagnostics – Diagnostic Systems. "Raising the standards of rapid influenza tests will provide healthcare providers the right information to guide patient diagnosis and treatment without requiring repeat testing."

BD pioneered the development of a higher performing test platform two years ago with the launch of the BD Veritor™ System Flu A+B test. BD recognized the need for an improved test early and developed and launched the first CLIA-waived flu test referenced to PCR that provides objective results on an easy-to-read digital display.  Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other management decisions. 

About BD

BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD'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 nearly 30,000 associates in more than 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit www.bd.com.

Contact: 
Jamie Yacco 
Public Relations 
(201) 847-4796 
Jamie_Yacco@bd.com

 


'/>"/>
SOURCE BD-Becton Dickinson
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Pharmaceutics International, Inc. (Pii) Supports University Pharmaceutical Technology Education and Research
2. Data Presented at the American Psychiatric Association Annual Meeting Supports Gender-Specific Dosing of Intermezzo® (zolpidem tartrate) Sublingual Tablets CIV
3. U.S. Government Supports Phase 3 Study of Bavarian Nordics Smallpox Vaccine
4. Frost & Sullivan: Expanding Sample Prep Market Supports Growth Trends in Molecular Diagnostics Markets
5. New Legislation To Make USPSTF More Transparent: Prostate Cancer Roundtable Supports Reform
6. Ventana Supports World Patient Safety Day, July 25
7. eCardio Supports the Carolinas HealthCare Foundation Through Grant for Heart Of A Champion Day
8. Verify Brand Supports the Proposed FDA Unique Device Identification (UDI) System for Medical Devices
9. Lilly Supports Research to Determine What a Dogs Nose Knows About People with Diabetes and Severe Hypoglycemia
10. Henry Schein Cares Supports Alliance for Oral Health Across Borders Leadership Event
11. Cardinal Health Supports Future Pharmacists With Nearly $1 Million In Scholarships
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... OAKLAND, N.J. , June 24, 2016 /PRNewswire/ ... in the design, development and manufacturing of collagen ... and regeneration announced today that Bill Messer ... Sales and Marketing to further leverage the growing ... surgery medical devices. Bill joins the ...
(Date:6/24/2016)... Va. , June 24, 2016 The ... set of recommendations that would allow biopharmaceutical ... (HCEI) with entities that make formulary and coverage decisions, ... the "value" of new medicines. The recommendations ... does not appear on the drug label, a prohibition ...
(Date:6/24/2016)... , June 24, 2016   Pulmatrix, Inc ., ... developing innovative inhaled drugs, announced today that it was ... Investments reconstituted its comprehensive set of U.S. and ... "This is an important milestone for Pulmatrix," said Chief ... shareholder awareness of our progress in developing drugs for ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now ... of Final Cut Pro X," said Christina Austin - CEO of Pixel Film Studios. ... Final Cut Pro X users can now reveal the media of their split ...
(Date:6/27/2016)... , ... June 27, 2016 ... ... the patient payment industry today announced its strategic partnership with Connance, a ... workflows. , The two companies’ proven, proprietary technology combine to provide health ...
(Date:6/27/2016)... Park, KS (PRWEB) , ... June 27, 2016 , ... ... in retailers of Eyeglasses . , Millions of individuals in the United States ... eyeglasses have become a way to both correct vision and make a fashion statement. ...
(Date:6/26/2016)... ... 2016 , ... On June 10-11, 2016, A Forever Recovery, a holistic treatment ... Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is located. This ... of the world’s leading providers of cereal and other breakfast foods. Its residents often ...
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements ... was developed to enhance the health of felines. The formula is all-natural and is ... herbs in the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus ...
Breaking Medicine News(10 mins):