BD Diagnostics Announces FDA 510(k) Clearance of BD Directigen(TM) EZ Flu A+B Test
September 27 2005 - 10:00AM
PR Newswire (US)
Rapid Diagnostic Tests Can Help Guide Selection of Treatment;
Judicious Use of Antivirals May be Critical in Event of Pandemic
Flu BALTIMORE, Sept. 27 /PRNewswire-FirstCall/ -- BD Diagnostics, a
segment of BD (Becton, Dickinson and Company), announced today that
the U.S. Food and Drug Administration (FDA) has granted 510(k)
clearance for the BD Directigen(TM) EZ Flu A+B Test. This two-step,
rapid influenza test is able to clearly differentiate between
influenza A and influenza B in fifteen minutes or less. A confirmed
differential diagnosis helps guide healthcare providers in the
selection of appropriate treatment, such as administration of
antivirals to certain patient populations. Analytical studies have
shown that the test is able to detect avian influenza H5N1
isolates. The BD Directigen EZ Flu A+B test features two distinct
windows on a single device to differentiate influenza A and
influenza B with maximum efficiency. The test offers convenient
room temperature storage. Commonly used oral medications, such as
throat drops, nasal sprays and ibuprofen, have shown no
interference with test results in analytical evaluations. It is
compatible with multiple transport media, and has been validated
for use with multiple specimen types. This saves laboratories the
additional time and resources required to validate alternate
transport media and specimen types. "Rapid diagnostics are
extremely important in that they allow healthcare providers to rule
out other respiratory infections, confirm a case of influenza, and
select the appropriate treatment in a timely manner," said Michael
Towns, M.D., Vice President, World Wide Medical Affairs, BD
Diagnostics -- Diagnostic Systems. "These capabilities are
particularly relevant when one considers that the window of
opportunity to effectively implement antiviral therapy is only 48
hours from the onset of symptoms. Antivirals can reduce the
severity of symptoms, shorten the duration of the illness, and
reduce the time period when patients who are ill with influenza are
infectious to others." A strain of avian flu has caused the death
or destruction of tens of millions of birds in eastern and central
Asia.(1) In addition, a total of 59 deaths and 115 confirmed cases
in humans have been reported to the WHO since January 2004. To
date, humans have only contracted bird flu after coming into
contact with infected animals.(2) The disease has many scientists
worried that it may mutate into a highly infectious pandemic flu
transmissible from human to human, with a high rate of morbidity
and mortality worldwide. "In the event of a human flu pandemic,"
explains Elliot Rank, Ph.D., Director of Scientific Affairs, BD
Diagnostics -- Diagnostic Systems, "diagnostic tests will be
absolutely necessary to ensure proper allocation of limited
supplies of antiviral therapies to those at high risk of
complications from the flu. Use of this two-step, easy-to-read,
rapid test can also help achieve the high levels of laboratory
efficiency that would be critical in the event of the high patient
influx and emergency patient care that would occur with an
influenza pandemic." About BD BD is a medical technology company
that serves healthcare institutions, life science researchers,
clinical laboratories, industry and the general public. BD
manufactures and sells a broad range of medical supplies, devices,
laboratory equipment and diagnostic products. For the fiscal year
ended September 30, 2004, BD reported total revenues of $4.935
billion. (1) http://www.who.int/csr/don/2005_08_18/en/index.html
(2) http://www.cdc.gov/flu/avian/outbreaks/asia.htm DATASOURCE: BD
(Becton, Dickinson and Company) CONTACT: Barbara Kalavik,
+1-201-847-4209, , or Alyssa Zeff, +1-201-847-4358, , both of BD
Public Relations Web site: http://www.bd.com/
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