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Hologic Receives FDA 510(k) Clearance of Quantra™ 2.2 Breast Density Assessment Software

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MARLBOROUGH, Mass., Nov. 24, 2017 /PRNewswire/ — Hologic, Inc. (Nasdaq: HOLX) announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Quantra™ 2.2 Breast Density Assessment Software, which enables clinicians to provide women with consistent breast density assessments during routine breast cancer screenings.

The software is one of several groundbreaking products that will be available for demonstration in Hologic’s booth (#4705) at the 103rd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) at McCormick Place in Chicago from Nov. 26 to 30.

Through a proprietary algorithm powered by machine learning, Quantra software analyzes mammography images for distribution and texture of breast tissue, delivering clinicians patient-specific breast density assessment. Quantra software categorizes breasts into four categories of density, in alignment with the ACR BI-RADS® Atlas 5th Edition.1,2

Nearly half of women between the ages of 40 and 74 have dense breasts, which can make it difficult to detect breast cancer during annual screenings and lead to additional imaging, resulting in increased patient anxiety and unnecessary facility costs.3,4 Perhaps most importantly, women with very dense breasts are four to five times more likely to develop breast cancer than women with less dense breasts.5,6 Breast density is only identifiable on a mammogram or other screening modality, and has historically been determined by the radiologist who reads the image. With Quantra software, clinicians can feel confident they are providing their patients with an unbiased breast density assessment that removes the potential for visual subjectivity.

“As the global leader in breast cancer screening technology, we relentlessly pursue the development of clinically superior products that address the unmet and changing needs of our customers and their patients, especially when it comes to breast density,” said Pete Valenti, Hologic’s Division President, Breast and Skeletal Health Solutions. “Quantra software is yet another example of our dedication and we are proud to feature it – along with a number of other new, breakthrough products – for the world’s leading radiologists at RSNA this week.”

Earlier this year, Hologic’s Genius™ 3D Mammography™ exam became the only mammogram approved by the FDA as superior to standard 2D mammography for routine breast cancer screening for women with dense breasts.7 The updated labeling was based on clinical studies proving that the exam improves invasive breast cancer detection while reducing unnecessary recalls among women of all

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