Rapid Diagnostic Tests Can Help Guide Selection of Treatment; Judicious Use of Antivirals May be Critical in Event of Pandemic Flu
Baltimore, MD - 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™ 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."
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.
This press release may contain certain forward-looking statements (as defined under Federal securities laws) regarding BD's performance, including future revenues, products and income, or 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; changes in interest or foreign currency exchange rates; difficulties inherent in product development and delays in product introductions; changes in regional, national or foreign economic conditions; increases in energy costs; fluctuations in costs and availability of raw materials and in BD's ability to maintain favorable supplier arrangements and relationships; and changes in healthcare or other governmental regulation; issuance of new or revised accounting standards, as well as other factors discussed in this press release and 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.