BD's Onclarity HPV PMA Submission to Boost Women's Health

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Becton, Dickinson and Company BDX, also known as BD, recently announced the submission of a pre-market approval (PMA) to the FDA for an expanded version of its BD Onclarity HPV (human papilloma virus) Assay.

Following the announcement, shares of the Zacks Rank #3 (Hold) company rose 2.5% to $248.30 at close.

Per management, the PMA submission is a significant step by BD toward enhancing women’s health and cancer portfolio.

More on BD Onclarity HPV Assay

The BD Onclarity HPV Assay detects and identifies 14 high-risk HPVs for cervical cancer screening purposes. The assay can be used with BD SurePath Collection Vial and the Hologic PreservCyt Solution for cervical cancer prevention.

The BD Onclarity HPV Assay is the only FDA-approved assay to individually identify and report different HPV genotypes associated with cervical cancer.

Notably, a PMA will provide laboratories and clinicians worldwide with comprehensive cervical cancer screening solutions.
An article by Cancer.Net predicts that an estimated 13,170 women in the United States are likely to be diagnosed with the disease in 2019.

BD and Women’s Health

Through the development of novel molecular oncology products, BD offers next-generation solutions in the field of cervical, ovarian and breast cancer.

The products include BD Totalys MultiProcessor, BD FocalPoint GS Imaging System and BD ProEx Reagent.

Focus on women’s health has increased in recent years and has considerably ramped up investments. From AI in women healthcare, cancer drugs to In Vitro Fertilization, the women’s health market is gearing up for a wave of innovation.

For instance, tech giant Intel INTC has partnered with privately-held MobileODT to develop an algorithm which identifies a woman’s cervix type based on images.

Per Global Market Insights, the global women’s health devices market is set to surpass $42.5 billion by 2025.

Price Performance

In a year’s time, shares of BD have rallied 3.3% against the industry’s 5.8% decline.

Key Picks

Some better-ranked stocks in the broader medical sector are DexCom DXCM and CONMED Corporation CNMD. While DexCom sports a Zacks Rank #1 (Strong Buy), CONMED carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

DexCom’s fourth-quarter earnings growth is projected at 29.6%.

CONMED’s long-term earnings growth rate is expected to be 17%.

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