Early breast cancer detection may soon become easier because of a new handheld ultrasound device that, when developed, will allow women to monitor their breasts at home.
A former biomedical scientist at NASA, Yehudit Abrams, an ultra-Orthodox Jew now living in Jerusalem, is the brains behind the product.
The ultrasound device, which will vary in size according to tbe woman’s cup size, translates data to an app which can then be analyzed and monitored for change every month, when the scans are performed. To use it, women would need to put the device onto one quadrant of their breasts and leave it there briefly. This procedure is repeated until four scans are done per breast plus the areas under the armpits.
The data is then transmitted through the app to the cloud, where the image is processed and analyzed through comparison to the thousands of images of breast pathologies in the software’s database.
“The moment the software identifies pathological changes in breast tissue, the app notifies the user, and the user can then send, via a secured link, historical images of the breast region in question directly to their physician for review,” Abrams said in an interview with The Times of Israel.
The US Food and Drug Administration has already approved the patented software. Abrams is now working on building the hardware around the software, and said it could take one to three years for the final product to reach the market.
Once the product completes pre-market clinical studies, the company will reapply for FDA approval, she said, as the software was originally approved for clinical use.
About one in eight women in the US will develop invasive breast cancer, according to Breastcancer.org, and some 40,920 women in the US are expected to die from the disease, though death rates have been decreasing since 1989, mainly due to advances in treatment along with earlier detection through screening and increased awareness.
Abrams, originally from Boise, Idaho, and a convert to Judaism, first came up with the idea of finding an easy way to monitor for early breast cancer while she was completing her post-doctoral position as a biomedical scientist at NASA, and after her cousin was diagnosed. She realized there was a need to help women objectify their breast self-exams.
Women are told by Breastcancer.org that there are five steps to doing a self exam –that checks for abnormalities and changes.
The breast self-exam is difficult because it is entirely subjective, and often, women do not know what they are feeling or meant to feel, said Abrams. So she started working on an app that included a breast map that would allow women to mark anything they found on their breasts and monitor developments on a monthly basis.
After she left NASA to work for an ultrasound company, she formed critical connections with ultrasound scientists around the world.
Shortly after moving to Israel nine months ago from San Diego, Abrams filed a provisional patent for her idea. A few months later, she was accepted to Mass Challenge, a global nonprofit startup acceleration and competition — where “things started getting done,” she said.
Last month, her newly formed company, called MonitHer, took the grand prize of $360,000 at the WeWork Creator Awards in Jerusalem.
The money received from the award will allow Abrams get a final patent for the device and hopefully to begin creating the prototype, she said.
Abrams said there is a market need for a device like hers, as screening mammograms are missing too many cancers and have a high false positive rate (one in three), causing $4 billion in expenditure due to over-diagnosis and treatment of breast cancer in the US alone.
Thus, mammograms are only done once every year or two, whereas ultrasound may be performed monthly, and are safer. Additionally, the mammogram alone is unreliable for women with dense breast tissue, which is true of 75% of women between ages 20-79, Abrams explained.
Finally, 20% of all breast cancers are of the Ductal Carcinoma in Situ (DCIS) type, which may or may not need treatment. Because around 30% of these tumors will become invasive, women undergo surgery and potentially radiation, which increases the risk for cancer. This means that around 70% of these tumors, though harmless, will be treated with surgery and irradiation unnecessarily, Abrams said.
Because testing with Abrams’s device is performed monthly, a woman who has DCIS might choose to monitor her breasts rather than undergo surgery and radiation, she said. The moment changes are detected in the breast, MonitHer’s software will alert the user of potential changes, and the user can immediately send a secured link to her physician. In this way, the physician can see if there is a change in the mass, and distinguish a change that requires follow up from one that does not.
Keeping cancer at bay
The key to keeping breast cancer at bay, Abrams said, is to monitor regularly, to keep tabs of the development, and to catch the cancer before it spreads to other parts of the body, after which survival rates drop exponentially. And that’s where her technology comes in, she said.
Women who use the device do an initial baseline, whole-breast ultrasound, then, every month, when reminded by the app, repeat their scans. Those scans will then be compared back to the baseline scan, so if there are changes, users will be notified and may send the images to their physician.
“Some 266,120 cases of invasive breast cancer are diagnosed every year in the US. And only 63,960 of the cases are of stage 0 cancer. I want to reverse those numbers. And the only way we can do this is through monthly monitoring.” said Abrams.
For the future, Abrams hopes to expand the capabilities of the device to not only distinguish between benign and malignant tumors, but also to distinguish between different types of malignancies and to to monitor the effectiveness of chemotherapy.
“Prevention is a daily effort. It’s something that a person really has to take charge of themselves. Doctors practice medicine, but only patients can practice prevention,” Abrams said.
“When mammography proved to reduce breast cancer mortality, we thought we’d had the solution, so governments around the world poured trillions of dollars creating a powerful mammography market. And we stopped innovating. The real solution is through partnering with patients in their own care,” said Abrams.