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Hologic Wins FDA Approval For Genius 3D Mammography Exam

Published 06/07/2017, 09:52 PM
Updated 07/09/2023, 06:31 AM
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A leading player in the field of women's health, Hologic, Inc. (NASDAQ:HOLX) continues to expand its Breast and Skeletal Health business through innovation and product development. As a major breakthrough, the company has declared the receipt of FDA approval for its Genius 3D Mammography exam for women with dense breasts.

According to Hologic, Genius 3D Mammography is the only FDA-approved mammogram test superior to 2D mammography for routine breast cancer screening.

Numerous clinical studies have proved that this new exam improves the detection of breast cancer across different age groups while reducing recalls from women with different breast density. Among women aged 40 to 74 years, 40–50% percent have dense breasts. Here, breast density is only identifiable on imaging modalities like mammogram which reflects the amount of fibrous or glandular tissues is breasts. Women with dense breasts are at higher risk of developing breast cancer.

Also, the company has announced the availability of data from a previously published multicenter clinical study (JAMA 2014). The study had demonstrated how breast tomosynthesis can be treated as the standard of care in women aged 40 and above. The study also showed that tomosynthesis in digital mammography has significantly increased the detection rates for invasive cancer in women aged 40 to 69. The recall rates for all age groups also declined.

The company clearly has considerable potential in the breast imaging market. According to Markets and Markets, the breast imaging market is expected to reach a worth of $4.14 billion at a CAGR of 8.5% from 2016 to 2021.

Recent Developments

The recent acquisition of Medicor, a distributor of breast and skeletal health products in Germany, Austria and Switzerland, provides Hologic a nice platform for international growth.

Last year, the company had received FDA approval for the Affirm prone breast biopsy system. This system gives radiologists access to different angles of breasts without moving the patient much.

Zacks Rank & Key Picks

Hologic currently carries a Zacks Rank #3 (Hold). A few better-ranked medical stocks are Align Technology, Inc. (NASDAQ:ALGN) , Inogen, Inc. (NASDAQ:INGN) and Accelerate Diagnostics, Inc. (NASDAQ:AXDX) . Notably, Align Technologyand Inogen sport a Zacks Rank #1 (Strong Buy), while Accelerate Diagnostics carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Align Technologyhas an expected long-term adjusted earnings growth of almost 24%. The stock added roughly 43.8% over the last three months.

Inogen has a long-term expected earnings growth rate of 17.5%. The stock has a solid one-year return of around 81.4%.

Accelerate Diagnostics has an expected long-term adjusted earnings growth of 30%. The stock added roughly 9.8% over the last three months.

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Hologic, Inc. (HOLX): Free Stock Analysis Report

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Align Technology, Inc. (ALGN): Free Stock Analysis Report

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