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Cepheid (CPHD) Gets FDA Clearance for Xpert TV Assay

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Cepheid recently received an approval for its Xpert TV assay from the U.S. FDA. Notably, Xpert TV is a urine-based test that uses the Nucleic Acid Amplification Testing (NAAT) procedure for detection of Trichomonas vaginalis, a non-viral sexually transmitted infection in men.

A thorough analysis reveals that the current market sentiments are quite unimpressive for Cepheid as it represents a modest one-year return of 1.3%, much lower than the S&P’s return of 10.1% over the same time frame. We believe that the recent development will to-some-extent help the company overcome the unfavorable situation.

Meanwhile, we note that Xpert TV had previously received an initial clearance for three types of female specimen in Oct 2015. The latest advancement not only extends the usage of the assay but also delivers rapid test-results in as less as 35 minutes. The company would initiate shipping of the newly modified version of Xpert TV later this month.

As per management, the approval will fortify Cepheid’s market position as it adds to the company’s flagship GeneXpert System. Notably, the platform has 20 Xpert tests in the U.S. and more than 11,000 systems installed globally.

Our Take

The molecular diagnostic market, with infectious diseases as an important platform is expected to reach a worth of $9,333.8 million by 2020, growing at a CAGR of 9.3%, as per Markets and Markets. Buoyed by such bullish trends, we believe that Cepheid is poised to gain from the latest development.

Zacks Rank and Other Key Picks

Currently, Cepheid has a Zacks Rank #2 (Buy).

Other favorably ranked stocks in the broader medical sector include CryoLife Inc. , Masimo Corporation (MASI - Free Report) and IDEXX Laboratories Inc. (IDXX - Free Report) . Notably, all the three stocks sport a Zacks Rank #1 (Strong Buy).

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