FDA clears Hologic’s Quantra 2.2 Breast Density Assessment Software during routine screening mammography

Hologic Inc. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Quantra 2.2 Breast Density Assessment Software. The software helps radiologists and clinicians to provide information about breast density to women during routine breast cancer screenings.

Quantra standardizes breast density reporting and helps eliminates the visual subjectivity by radiologists, through a proprietary algorithm powered by machine learning. The software classifies the breast tissue into four density categories based on  ACR Breast Imaging Reporting and Data System( ACRBI-RADS®) Atlas 5^th Edition, based on the distribution of fibroglandular tissue  and texture of breast tissue.

The BI-RADS® Atlas provides standardized breast imaging findings terminology, report organization, assessment structure and a classification system for mammography, ultrasound and MRI of the breast.

The Quantra software is compatible with Hologic's 3D Mammography systems, including the new 3Dimensions mammography system, which is designed to be the fastest, highest resolution breast tomosynthesis system ever, with the 'Intelligent 2D imaging technology'.

Nearly 40% of women between the age of 40 and 74 have dense breasts, which can make it difficult to detect breast cancer during annual screenings and necessitates additional imaging, resulting in increased patient anxiety and unnecessary facility costs. 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.

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

Pete Valenti, Hologic's Division President, Breast and Skeletal Health Solutions said, "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. 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, FDA approved its Genius 3D Tomosynthesis Mammography as the only test superior to 2D mammography for routine breast cancer screening for women with dense breasts. 

Hologic also commercially launched its SmartcCurve breast stabilization system at the same time, that makes mammography experience less painful for women without compromising on image quality and diagnostic accuracy.

Hologic Worldwide Quantra Volumetric Breast Density Assessment

FDA labels Hologic Genius 3D Tomosynthesis Mammography superior for visualization of dense breasts

Hologic, a leading global healthcare and diagnostics company continues to expand its Breast Health portfolio through continued innovation and product development. As a breakthrough, FDA recently approved its Genius 3D Tomosynthesis Mammography as the only test superior to 2D mammography for routine breast cancer screening.

The Genius exams is available to public since 2011, but the newly approved labeling comes in wake of results of clinical studies showing “the exam improves invasive breast cancer detection while reducing unnecessary recalls among women of all breast densities, including those with dense breasts,” according to press release by Hologic.

To find out who offers Genius 3D mammography in your area in USA, click here. 

Among women between the age of 40 to 74 years, nearly 40% to 50% have dense breast. Dense breast also increases the likelihood of developing cancer by 5 to 6 times as compared to women with normal breast density.  Often the cancers are detected very late in women with dense tissue because of imaging difficulty.

Density of breast is a measure of amount of fibrous or glandular tissue in breast and can only be identified by imaging techniques. To make patients aware about it, 31 states in US requires notification to be sent to patients after a mammogram.

"Radiologists and referring physicians needed an answer for how to screen the roughly half of women with dense breasts, because until now, this patient population was confused and frustrated without a clear path forward," said Pete Valenti, Hologic's Division President, Breast and Skeletal Health Solutions. "We are pleased today to provide this definitive guidance from the FDA that the Genius exam is a superior screening solution for women with dense breasts. This is yet another reason referring physicians can feel confident in recommending Hologic's Genius exam."

Although Conventional 2D mammography is currently the gold standard, it has limitations in women with dense breast because the dense tissue can overlay on top of each other and potentially hide small cancers.

The main advantage of 3D tomosynthesis is it can clearly delineate the underlying breast tissue, irrespective of breast density.  This enables the diagnosis at very early stage and reduces false positives results, thereby avoiding unnecessary biopsy.  

It is also a method of choice in women who are at high risk for developing cancer or women who are referred for breast lump.

Another screening modality for women with dense breast is Innovative Breast Ultrasound system: the Invenia Automated Breast Ultrasound System(ABUS).

To get information on personalized breast screening click here 

Here is a video by Hologic about how Genius 3D mammography is performed.