Aside from recognized and proven quality, what distinguished Hologic from other manufacturers for decades was their dedication to a cause, their focus. They were always eager to learn more from the professionals, both radiologists and technicians, about how they could improve the device.
Everybody knows what mammography is, but few people will tell you what is Tomosynthesis. Mr. Momčilo Mirić is the CEO of TIM Co. a company that more than 20 years is introducing new technologies into the regional health systems. Being a representative of the most recognized promoter and protector of Woman’s Health, dedicated medical equipment manufacturer HOLOGIC, Inc., based in the U.S., TIM Co. had an easy task to just “spread the word”.
HOLOGIC is a global leader in early breast cancer detection, osteoporosis and cervical cancer screening equipment, being the inventor of a series of new solutions and improvements continuum of both equipment features, diagnostics and treatment protocols. Hologic’s Science of Sure reflects a leading innovator in women’s health, helping healthcare professionals around the world. Hologic’s innovations are designed to achieve exceptional clinical results, making it possible to detect, diagnose and treat illnesses.
In the U.S. they have nearly 9.000 facilities with mammography units. MQSA is an organization that takes care of the Quality Control of all those centers where mammography takes place.
What exactly made Hologic a mammograph of choice throughout the world, and especially here in Serbia, the fact is, Hologic takes around 70% of all mammography units in the Republic, is simply a better mammogram.
Marina Dwight Smith, Director of Mammography Quality at Parkview Health, Indiana said: “The Genius® 3D™ (*) exam is a game-changer. It has allowed the radiologist to see things they’ve not seen before.”
(*) Genius® 3D™ is part of a screening organisation in the U.S., all places registered for screening and equipped with Hologic mammography with tomosynthesis.
Aside from recognized and proven quality, what distinguished Hologic from other manufacturers for decades was their dedication to a cause, their focus. They were always eager to learn more from the professionals, both radiologists and technicians, about how they could improve the device. Their R&D department was constantly in communication with end-users. That specific relation iteratively brought many patents to life.
One of their most prestige inventions was a 3D mammography – tomosynthesis. Namely, for 40 years mammograms were of the same technology, with limited diagnostic quality. But, they were the only weapon against the hidden breast cancer – the so-called “gold standard”. The fact that, when making a mammogram, the technician projects breast volume (with all details in it) to a 2D image, was the main reason for relatively low specificity and sensitivity, as breast tissue was overlapping on the image. Overlapping tissue was either hiding small cancers, generating results known as a “false negative”, or even simulating shapes like cancer lesions, generating “false positive” findings. Such 2D mammograms we call conventional mammograms, regardless they are analog, digitized, or digital.
In the year 2017, Hologic commercialized the new, second-generation tomosynthesis mamo devices. A completely new advanced digital detector was applied, with a new, better resolution.
The main idea was to eliminate the overlapping problem and to raise specificity and sensitivity. It was perfectly done with the X-ray tube rotating at a small angle taking images during rotation. That way the unit was generating 15 projections that all were processed in the powerful computer and, as a result, the radiologist could read perfect slices of only 1mm thickness. It was very similar to a medical CT scanner.
Now, small cancer has no place to hide, as small cancer is considered, say, less than 10mm. The beauty of tomosynthesis technology is the fact that radiologist has the opportunity to look at each tiny slice of the breast, one by one, having no chance to miss cancer. It is like you are reading a book.
And why it is important? Our goal is to save lives. Tomo-mamograms let doctors see more, so they could catch cancer at its earliest and most treatable stage. Early detection is the key. The smaller the discovered cancer is – the greater chances for the patient to be cured. It is considered that if cancer is discovered early enough, there is an over 95% chance of the patient surviving. At the same time, small cancer is not palpable, making it difficult to be discovered, but also difficult to be treated. But, with tomosynthesis, most of the very small cancers are easily discovered.
At the onset of Hologic tomosynthesis, all were using conventional mammography units. Within the first year of commercially available 3D mammography, over 30% of facilities ultimately changed their equipment to Hologic tomosynthesis. The first competition device (GE) came only three years later. Nowadays, we are proud to say that all mammography devices manufacturers have their model of mammography unit with tomosynthesis.
In the year 2005, on October the first, Hologic CEO, Mr. Jack Cummings was the first one to loud ring a bell, signaling the opening of the NASDAQ day’s trading. Each year, on the first of October, Breast Cancer Awareness Month, Hologic is opening NASDAQ. The iconic bell-ringing ceremony at Nasdaq MarketSite became a tradition that additionally raises breast cancer awareness.
HOLOGIC mammography devices were the first to be used in many clinical trials throughout the world. And the results were revolutionary! Radiologists were eager to evaluate this new equipment in clinical trials, and many started simultaneously trying to understand the real benefits of the new technology. Soon first results started popping out from new clinical trials. The trials were organized in Norway, already well known for highly organized breast cancer screening, in Italy, the U.K., Spain, in the U.S., one by one with more and more women involved and participating in the studies. Most studies were screening clinical trials where the goal was a comparison between 2D and 3D mammography.
By the end of 2008, the first generation of digital mammography with tomosynthesis was available on the market, already in 2013, we had the first peer review results. It was confirmed that new mammography with tomosynthesis discovers 42% of small, invasive cancers more than conventional 2D mammography. At the same time, all studies showed a fall in the Recall Rate. Recall Rate is an important factor that defines the quality of a breast cancer screening.
It is a number of women called again, after mammography, to perform additional investigational procedures, like ultrasound, or magnetic resonance (MRI), as by reading a mammogram, the radiologist couldn’t be conclusive about the suspected lesion, spotted on the screening mammogram. The lower this number is – the better the screening is. So, in most of the studies, the Recall Rate was even 40% lower.
In the year 2017, Hologic commercialized the new, second-generation tomosynthesis mamo devices. A completely new advanced digital detector was applied, with a new, better resolution. For the first time, the resolution of the full-field digital mammography (FFDM) with a pixel size of 70 microns was matched with the tomosynthesis mammogram. Simultaneously, Hologic additionally improved the simplicity of work for the technician, and highly improved the comfort of the patient.
As the Clinical Studies were performed further, many of them went to a second phase with the new equipment, and expectedly, considerably new improvements showed better results. The newly diagnosed small, invasive, breast cancer was discovered for 65% more than on a 2D mammography, and the Recall Rate was kept on the same level, with No Compromise, and No Comparison!
At the end of 2019, Hologic had more than 200 clinical trials, over 40 of them in breast cancer screening, with over two million (2.000.000) women participating in the studies worldwide, counting over 1.75 million only in the screening studies. These were stunning revolutionary results that led to the absolute supremacy of Hologic early breast cancer detection equipment.
So, we can say nowadays that Hologic is the only company with clinically approved technology. Unfortunately, the competition failed to reach these results. There are three words defining the Hologic strive: Purpose, Passion, Promise
By Momčilo Mirić CEO at TIM Co.