Becton, Dickinson Gets CLIA-Waiver for RSV Test System - Analyst Blog
March 24 2014 - 3:00PM
Zacks
Medical technology major Becton, Dickinson and
Company (BDX) revealed that it has received 510(k)
clearance and Clinical Laboratory Improvement Amendments (CLIA)
waiver from the U.S. Food and Drug Administration (FDA) for
nasopharyngeal swab specimens on the BD Veritor System, intended
for Rapid Detection of Respiratory Syncytial Virus (RSV).
Within a couple of trading sessions after the announcement, shares
of Becton, Dickinson reached a new 52-week high of $117.07 in
mid-day trading on Mar 21 to close at $114.57 on the same date. The
closing price represented a strong one-year return of 27.1%.
BD Veritor System is cleared for use in physician chambers,
hospitals, and other patient-care centers. It is the first
commercially available CLIA-waived RSV test system that produces a
digital result.
BD Veritor System is also the third FDA-cleared and CLIA-waived
offering of Becton, Dickinson. Previously, the company’s BD Veritor
System had received both FDA clearance and CLIA waiver for Rapid
Detection of Flu A+B and Group A Strep.
Becton, Dickinson’s new RSV test takes help of the Advanced
Nano-particle and Adaptive Read technologies, when used in
combination with the BD Veritor System Reader, to present the test
results on a hand held reader with a digital display. The Advanced
Particle Technology improves the sensitivity of the test while the
Adaptive Read Technology reduces false-positive results.
As per the U.S. Centers for Disease Control and Prevention, RSV is
the most prevailing cause of pneumonia and bronchiolitis in the
U.S. in children under the age of one year, causing about 75,000 to
125,000 hospitalizations per year. Most of the children are
infected with the virus when they are two years old.
Becton, Dickinson posted adjusted earnings per share of $1.42 for
the first quarter of fiscal 2014, topping the Zacks Consensus
Estimate of $1.29 as well as the year-ago earnings of $1.35 by
5.2%.
Revenues in the quarter went up 6.1% to $2,015 million, also
exceeding the Zacks Consensus Estimate of $1,979 million. In
constant currency, revenues grew 6.7% in the quarter. The increase
in revenues was attributable to favorable timing of orders in the
BD Medical and BD Diagnostics segments.
For fiscal 2014, Becton, Dickinson continues to expect revenue
growth in the range of 4.0 to 5.0%, both in reported and constant
currency. The company also anticipates adjusted earnings per share
between $6.19 and $6.22 for the year (compared with the prior range
of $6.16 to $6.22), reflecting year-over-year growth of 6.5–7.0%
over fiscal 2013. The current Zacks Consensus Estimate of $6.23
lies above the guided range.
In constant currency, adjusted earnings per share are now
anticipated to grow between 9.0 and 9.5%, or between 9.5 and 10.0%
excluding the incremental impact of the medical device tax.
Currently, Becton, Dickinson carries a Zacks Rank #2 (Buy). Other
favorable stocks in the medical/dental supply industry include
Align Technology Inc. (ALGN), Cardinal
Health, Inc. (CAH), and Uroplasty, Inc.
(UPI). All othese stocks carry a Zacks Rank #2.
ALIGN TECH INC (ALGN): Free Stock Analysis Report
BECTON DICKINSO (BDX): Free Stock Analysis Report
CARDINAL HEALTH (CAH): Free Stock Analysis Report
UROPLASTY INC (UPI): Free Stock Analysis Report
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