Medical technology major
Becton, Dickinson and Company
) 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.
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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withdrawn from the market about a year after the rule is
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.
The Cooper Companies Inc.
Align Technology Inc.
). All of them carry a Zacks Rank #2 (Buy).