Becton, Dickinson Gets CLIA-Waiver for RSV Test System - Analyst Blog

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.