Medical technology major Becton, Dickinson and Company (BDX) agreed with U.S. Food and Drug Administration's (FDA's) proposal to reclassify rapid influenza detection tests (RIDTs) from Class I devices into Class II devices. The proposal was examined by FDA's CDRH Microbiology Devices Advisory Committee Meeting at a hearing in June this year.
The reclassification will improve the performance of RIDTs. The reclassified tests will attain at least 90% sensitivity for influenza A and 80% for influenza B versus viral culture and/or 80% versus polymerase chain reaction (:PCR) methods.
The need for reclassification arose due to poor performance of point-of-care flu tests in 2009 flu pandemic. Years of publications have identified the poor sensitivity of many visual read RIDTs when compared with viral culture and reverse transcription PCR methods.
The reclassified standards will help healthcare providers achieve the right information, enabling proper diagnosis and treatment of patients without opting for repeat testing. If the devices failed to meet the minimum clinical performance criteria, they will be withdrawn from the market about a year after the rule is finalized.
BDX recognized the need for high performance testing platform long time back. Two years ago, the company has launched the BD Veritor System Flu A+B test. It has also introduced the first CLIA-waived flu test referenced to PCR that provides objective results on an easy-to-read digital display.
Recently, BD Medical, a segment of Becton, Dickinson and Company, has launched a new prefillable polymer syringe, which is specially engineered to deliver large volume of drugs by intravenous infusion. Due to its high infusion rate, the syringe can be used for anesthesia, pain management, cardiac therapy and nutrition amongst others.
The advanced syringe is made with a highly advanced cyclic olefin polymer that is enabled to provide several advantages to drug manufacturers and healthcare professionals including reduced breakage, glass-like transparency, and low levels of extractables. Along with a specific coating technology, this special type of polymer provides smooth gliding, delivering an accurate and consistent infusion rate.
Becton, Dickinson and Company reported a marginal 1.3% rise in third quarter fiscal 2013 adjusted earnings per share from continuing operations to $1.54, beating the Zacks Consensus Estimate of $1.47. Revenues went up 3.6% (up 5.1% in constant currency or CER) to $2,052.7 million, which were marginally ahead of the Zacks Consensus Estimate of $2,050 million.
BDX reiterated its guidance for fiscal 2013. The company expects sales growth for fiscal 2013 in the range of 3.5% to 4% (growth of 5.0% at CER) compared with 4.5% to 5.0% earlier).
Becton, Dickinson and Company also continues to expect reported earnings per share from continuing operations for fiscal 2013 in a band of $5.72−$5.75. The projection implies a year-over-year rise of 6.5%−7.0% (8.5%−9.0% at CER) for fiscal 2013 or 11.0%−11.5% after accounting for the medical device tax implemented in Jan 2013.
Currently, BDX carries a Zacks Rank #3 (Hold). Other medical stocks that are worth considering include Alphatec Holdings, Inc. (ATEC), The Cooper Companies Inc. (COO) and Align Technology Inc. (ALGN). All of them carry a Zacks Rank #2 (Buy).
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