BD Veritor System Meets FDA’s New Performance Requirements for Rapid Influenza Antigen Detection Tests

Health care providers and laboratories may be better equipped to test and treat patients during the flu season

Feb 22, 2017

FRANKLIN LAKES, N.J., Feb. 22, 2017 – Effective Feb. 13, 2017, the Food and Drug Administration (FDA) has reclassified antigen based rapid influenza virus antigen detection systems (RIDTs) intended to detect influenza virus directly from clinical specimens from Class I devices into Class II devices subject to special controls.

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that its BD Veritor System Flu A+B, a digital immunoassay for the rapid detection of influenza, meets the new FDA performance requirements. 1

Prompting these changes was the inadequate performance of some point-of-care flu tests available during the 2009 flu pandemic, which raised concerns regarding the accuracy of detecting influenza in patients. With the new FDA requirements,i rapid flu tests, which are used by health care providers and laboratory personnel, must now attain a higher level of performance.

"The change to the new performance standards may help improve the overall quality of testing for influenza," said Dr. Charles Cooper, vice president of medical affairs at BD. "This agency's decision has the potential to improve patient outcomes — ensuring that the tools health care providers use for diagnosing influenza meet new, higher standards for accuracy. As we know, an accurate diagnosis helps to determine appropriate use of antiviral medications, while at the same time reducing inappropriate over-prescription of antibiotics, which can only help in the fight against antimicrobial resistance."

As part of the new reclassification of rapid flu tests from Class I to Class II, the FDA is raising the tests to higher performance standards. This change will help to ensure that health care providers and allied health professionals who use rapid flu tests to detect influenza viruses will have quick access to more accurate information.

In recognizing the need to improve diagnostics, BD developed and launched the BD Veritor System for Rapid Detection of Flu A+B. This was the first Clinical Laboratory Improvement Amendments (CLIA)-waived flu test that provides objective results on an easy-to-read digital display. The now Class II BD Veritor System Flu A+B test became available in 2011, and is the same test used on the new BD Veritor Plus System, a next generation wireless rapid diagnostic system for detection of influenza A and B, respiratory syncytial virus (RSV) and group A strep.

More information about the FDA reclassification and the BD Veritor Plus System are available at http://www.bd.com/ds/VeritorSystem or through BD Technical Service at 800.638.8663.

About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of healthcare by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to healthcare. In 2017, BD welcomed C. R. Bard and its products into the BD family. For more information on BD, please visit bd.com

For more information on BD, please visit bd.com.

Troy Kirkpatrick

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Monique N. Dolecki

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Rapid Influenza Antigen Detection Tests (RIDTs) and the New FDA Reclassification

What You Need to Know About Rapid Influenza Antigen Detection Tests (RIDTs) and the New FDA Reclassification

BD Veritor™ System Flu A+B Meets the New FDA Requirements

  1. Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens, 82 Fed. Reg. 3609 (January 12, 2017) https://www.federalregister.gov/documents/2017/01/12/2017-00199/microbiology-devices-reclassification-of-influenza-virus-antigen-detection-test-systems-intended-for.