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BDX Launches DNA Assay for Trichomoniasis

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BD Diagnostics, a segment of medical technology major Becton, Dickinson and Company (BDX), has launched the BD ProbeTec Trichomonas vaginalis Qx Amplified DNA Assay used for the detection of T. vaginalis DNA in endocervical and vaginal samples as well as neat urine specimens to aid in the diagnosis of trichomoniasis on the BD Viper System with XTR Technology.

The DNA assay has been cleared by the U.S. Food and Drug Administration (:FDA). It is designed for use with the BD Viper System. It reduces human intervention and associated variables as well as improves speed to results compared to wet mount microscopy and culture.

The need for an automated platform such as BD ProbeTec DNA Assay was awaited due to the increasing prevalence of trichomoniasis around the world. Globally, more than 180 million cases of this sexually transmitted infection (STI) have been registered.

Trichomoniasis causes genital inflammation and may lead to women’s susceptibility to HIV infection as well as to HIV transmission to their sex partners. As a result, detection of this STI is extremely important for timely and accurate diagnosis of trichomoniasis.

Recently, 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.

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.

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 STRAUMANN HLD N AKT (SAUHF) with a Zacks Rank #1 (Strong Buy), and Alphatec Holdings, Inc. (ATEC) and Align Technology Inc. (ALGN), both with a Zacks Rank #2 (Buy).

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