FDA Approved New Genius 3D Mammography Exam That Improves Cancer Detection, Reduces Patient Anxiety

Women with dense breasts can now rest a bit easier knowing that the new Genius 3D Mammography Exam has been approved by the FDA. This machine aids early detection of breast cancer and reduction recall rates for all women and all breast types.

According to studies compiled by Hologic, between 40 and 50 percent of women of screening age have dense breasts, thus putting them at a higher risk of developing breast cancer and leaving them – and their doctors – with a multitude of unanswered questions about the best path forward when it comes to breast cancer screening.

Since this has been approved by the FDA, these women will be able to be helped quicker, thus relieving anxiety and unnecessary time and costs associated with multiple return visits.

"The Genius 3D Mammography exam is now the only mammogram available that is FDA-approved as superior for women with dense breasts for routine breast cancer screening over conventional 2D mammography. The Genius exam, on the market since 2011, is available in all fifty states and this updated labeling is based on clinical studies proving that the exam improves invasive breast cancer detection while reducing unnecessary recalls among women of all breast densities, including those with dense breasts," according to the Hologic Team.

Sally Friedewald, MD, Chief of Breast and Women's Imaging, Northwestern Memorial Hospital, spoke with Michelle Tompkins for the Inquisitr about this important new technology, as well as offering information and tips on how to make your next trip to the radiologist more productive.

Michelle Tompkins: Where did you to medical school?

Dr. Sally Friedewald: I went to school at Columbia, New York City.

MT: What made you choose this path of science?

SF: I really enjoy working with women, and I feel that as a physician, I can really make a difference, and it sounds corny but save lives.

MT: Can you please tell me a little bit about your background?

SF: Sure. I specialize in breast imaging, which means I look for breast cancers and try to find them when they're small so that they are curable. I trained on the east coast as I mentioned, at Columbia and John's Hopkins, and I did my fellowship at the University Pennsylvania in Philadelphia, and I am working now in Chicago.

MT: Now, when you hear the word mammogram what goes through your head typically?

SF: It's an opportunity to find cancers before they become palpable or felt by the patient or the physician and therefore we increase our chances of saving lives.

MT: What is the best thing about your job?

SF: The best thing about my job is that I'm helping women. I can understand the anxiety that they're going through and I can help them through a very anxiety provoking time. And it's very rewarding knowing that although there can be times of stress and the exam itself is a little uncomfortable, the vast majority of patients do extremely well.

MT: What is the worst thing about your job?

SF: The worst thing about my job honestly is telling people that they've got breast cancer. It's not fun to do, but I do feel that I can do it in such a way that can be comforting for patients. And so although it's a hard conversation to have and patients don't want to hear that answer, I'm in a position where I can help them significantly.

MT: Thank you for that piece of information. Now, when women do a self-exam, what should they be doing?

SF: It's important to understand the landscape of your breast. So the texture of the breast can change from month to month. So once you get to understand what your breast feels like, if there's a change in your breast that has occurred longer than a month then we definitely recommend that you come in. And the change could be either a lump or skin thickening or dimpling or nipple discharge. So those are all important features to look for when you're examining your breasts.

MT: Now, who should get mammograms?

SF: Every woman aged 40 and older should get annual mammograms. It's the best way to detect breast cancer that we currently have and has been shown to save lives so it's very, very important.

MT: Now, what are dense breasts?

SF: Dense breasts are a discussion about the contents of the breast. So women who have dense breasts have more of the fibrous and glandular tissue in their breast relative to fat, whereas women who have fattier breasts have less of those elements. And what makes it difficult for the radiologists, the ones reading the mammogram is that the dense breast tissue can hide a breast cancer, so we find it more challenging to find breast cancer in women who have dense breasts.

Genius 3D from Hologic
[Image by Genius 3D/Hologic]

MT: Now, what is the difference between a 2D and a 3D mammogram?

SF: Historically, is the standard of care for breast imaging to detect breast cancer. We now have 3D mammography, which is largely replacing 2D mammography, and we are able to see through that breast tissue a little bit more easily. I use the analogy of pages in a book. So if you have a book, that is a 2D book, you can only see the front cover, but with a 3D mammogram, it's similar to opening up the book and paging through the breast page by page so you can see what's inside.

MT: Now, what do people need to know about Genius exam?

SF: The Genius 3D mammogram machine made by Hologic is really the only 3D mammography unit that has shown to improve cancer detection in women with dense breasts. So there are other manufacturers that have this technology, but the outcomes are not as apparent.

MT: And now, why is this new technology important?

SF: It's important for us to detect breast cancer at the very early stage, so if we can detect it at a smaller size, then the patient has a greater chance of surviving the breast cancer. And with the 3D mammography, we are able to find that cancer earlier.

What are risk factors for breast cancer?

MT: Now, what are some factors that make it more likely for people to have breast cancer than not?

SF: There are certainly risk factors. Most significantly if patients have a strong family history of breast cancer, and particularly, if they have a gene mutation, that predisposes patients to having breast cancer. The most common ones are called BRCA1 and 2. So those are patients that tend to have high risk. Also, the patients that had radiation to the chest at a young age, between 10 and 30, they also have a higher risk of breast cancer.

MT: Now, do you have an FDA approval?

SF: Yes, we do, since 2011. And our studies, that we have done showing the benefits of tomosynthesis, were performed and published in 2014.

MT: Now, what's next for this technology?

SF: My belief is that it will become the standard of care, it is nearly there, and this technology is available in all 50 states and insurance companies are covering it in many states. Medicare and most Medicaid is also covering.

MT: Now, what are some questions that women should ask when they talk to their doctor during a mammogram?

SF: It's important to know whether the machine is a 2D mammogram machine or a 3D. It's not readily apparent whether it's one or the other, and so patients may not know which machine that they are getting their mammogram.

MT: Now, how do you want people -- how do you like people to connect with you?

SF: People can contact me at -- to go to Northwestern Memorial Hospital's website and they certainly can look me up and I'd be happy to explain more.

MT: Now, where can people find more information about this technology?

SF: If patients are interested in finding out more about the technology and where or which facilities have the capability, they can go to Genius3Dnearme.com.

[Featured Image by Hologic, Inc.]