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10 Ways Medtech Is Battling Breast Cancer

Here are some of the latest advances in detection, diagnosis, and treatment, in recognition of Breast Cancer Awareness month.

  • Intraoperative Radiation Therapy

    At last month’s American Society for Radiation Oncology (ASTRO) annual meeting, researchers presented findings from a Vanderbilt University School of Medicine study supporting Xoft intraoperative radiation therapy (IORT) for early-stage breast cancer. IORT with the Xoft System employs a miniaturized x-ray source to deliver one concentrated dose of radiation directly to the tumor site, minimizing risk of damage to healthy tissue in nearby areas of the body, the company reported in a news release.

    According to an abstract shared with MD+DI, the study concluded that “IORT is a convenient and well-tolerated treatment option for the appropriately selected woman undergoing partial breast irradiation.” The study involved 100 patients (101 tumors), with a median age of 66 and a median follow up of 3.8 years. It found that “rates of seroma formation are similar to rates reported for multiplefraction catheter based systems.”

    A spokesperson further told MD+DI that the Xoft System “allows breast surgeons and radiologists to work together to deliver an entire course of radiation in a single fraction at the time of lumpectomy, in as little as eight minutes. This allows appropriately selected patients to potentially replace six to eight weeks of post-operative external beam radiation therapy (EBRT) with a single-fraction of radiation, while the patient is still asleep at the time of lumpectomy.”

    Michael Klein, Chairman and CEO of iCAD, stated in the release that “We may be approaching a significant paradigm shift in the way clinicians treat cancer, especially with a likely decision on the Radiation Oncology Alternative Payment Model (RO-APM) anticipated in the months ahead. As a single-fraction treatment therapy for early-stage breast cancer, Xoft IORT is a viable and verified treatment option that appears well-aligned with the core elements of the proposed model.”

    The Xoft System uses a miniaturized x-ray source to deliver one precise, concentrated dose of radiation directly to the tumor site, while minimizing risk of damage to healthy tissue in nearby areas of the body. Photo and caption credit: iCAD Inc.
  • Visual Intelligence for Screening

    Even with the most advanced mammography systems, radiologists have a tough time spotting cancer in dense breast tissue because density shows up white in an x-ray and cancer is a density.

    Tom Ramsay, an image processing expert and master photographer, founded Lansdowne, VA-based Imago Systems to develop an advanced visualization software that is designed to dramatically improve a clinician’s ability to detect cancer and other abnormalities earlier and more accurately. The software delivers what the company calls "visual intelligence" to help clinicians observe and identify abnormalities at the earliest possible stage. What makes this system unique is that instead of writing an algorithm to detect cancer, Imago's algorithm was created to show everything, while enabling the images to self-define and differentiate from cancerous tissue. 

    "So now we don't have to go and run a million mammograms to try to define what cancer looks like, cancer will tell us that it's there," Ramsay told MD+DI. "Benigns will differentiate from cancers and normal tissue will have their own patterns."

    In other words, Ramsay said, "We're not detecting anything but we're showing everything."

    Imago Systems has even gained the confidence of Mayo Clinic, which recently signed on to support the company's clinical trial. The multi-year agreement will focus on clinical trial support for Imago Systems' ICE Reveal product for breast imaging and includes financial investment from Mayo Clinic.

    Image courtesy of Imago Systems
  • MRI for Diagnosis

    In terms of diagnosing breast cancer, Philips is hoping “to see a continued change in the way MRI is utilized,” Martijn Hartjes, head of global product marketing, MRI, Philips, told MD+DI.

    “A mammogram is still the least expensive and easiest way to screen for breast cancer; however, we are starting to see a rise in the use of MRI for screening, namely for women at high risk for breast cancer,” he explained. “MRI screenings provide better visibility to enable clinicians to assess the potential threat of breast cancer. This enables early detection and allows patients and their clinician to put together an effective care plan sooner to improve outcomes. The role of conventional mammography is still very important, since it has proven to be very effective as well, but the role of breast MRI in diagnosing breast cancer is increasing based on clinical evidence.”

    Philips offers a suite of breast cancer solutions ranging from MRI to informatics to ultrasound, said Hartjes. These solutions “give clinicians the tools and information they need to help deliver confident care that is fast, easy, and more comfortable for patients every step of the way," he said.

    For example, “for patients who need MRI, breast coils make the experience as comfortable as possible, while enabling radiologists to get the clinical information they need the first time,” he said. “Beyond this, Philips’ MRI solutions include features that improve the speed and consistency of exams, such as SmartExam Breast to suppress fat, the mDIXON XD FFE to retrieve multiple images in one type of scan, and Compressed SENSE, which accelerates the scan process without compromising image quality. For enhanced lesion detection, Philips’ 4D-THRIVE provides high-resolution imaging, and MR Diffusion, a single-shot EPI imaging method that can be used for non-invasive tissue structure assessment. These technology solutions are important to make MRI systems leveraged more readily for breast screenings.”

    Breast MRI, however, has been “underutilized,” he noted. Reasons could include awareness, cost, coverage, and accessibility. “An MRI scan has a higher cost than mammography or ultrasound,” he said. “Reimbursement for MRI varies by country. In the U.S., not all health insurances fully reimburse an MRI scan for breast imaging. In some countries there is no reimbursement at all or legislation needs to be in place to do a screening with MRI. We also know that there is sometimes a certain reluctance or anxiety for women to undergo an MRI exam. It takes longer than mammography, there is noise, the position in which they are scanned isn’t always that comfortable. These are all aspects that may create reluctance.”

    The American Cancer Society’s recommendation to screen women at high risk with MRI could help change things, Hartjes reported. In addition, “we’re also starting to see reimbursement coming up for breast screening using MRI, and I believe we’ll see it develop for other screenings as the industry realizes the unique value MRI can bring," he added. “MRI purchases are increasingly becoming much more strategic decisions for hospitals in terms of clinical decision making and patient outcomes. As we move to faster, AI-driven scanning, and personalized medicine, more and more healthcare providers have come to understand the key role MRI, or imaging in general, can play in a certain disease’s pathway – whether it is simplifying the pathway, making it a pathway at a lower cost, or one with higher specificity.”

    Image courtesy of Philips
  • A Blood Test in the Pipeline

    Oncimmune Holdings plc, which developed the EarlyCDT Lung blood test, has a breast cancer test in its pipeline.

    Oncimmune’s technology aims to detect evidence of the body’s natural response to cancer. “When cancers form, it is the result of cells in the body starting to behave abnormally by producing mutated proteins,” Adam Hill, CEO of Oncimmune, told MD+DI. “These changes trigger an immune response including the release of autoantibodies to the aberrant proteins. Unlike most other biomarkers, autoantibodies can then be measured in the patient’s blood in response to even the smallest of tumours, making tumour associated autoantibodies ideal biomarkers for early cancer detection. Oncimmune has demonstrated that tumour associated autoantibodies are produced and measurable in the earliest stages of breast cancer.”

    This test would differ from other available approaches. “Early cancer detection tests typically rely on measuring the tumour, or its products directly (e.g., circulating tumour DNA or ctDNA). Therefore, the level of non-immune biomarkers is related to the size and activity of the tumour. Detecting these markers in small tumours can be difficult in a standard blood sample. The immune system provides us with an amplification step and so the signal can be high, even for the smallest tumour,” Hill explained.

    Because tumors are difficult to detect in women with dense breast tissue, “a blood test could improve diagnostic accuracy and may be more acceptable as a case-selection tool to help drive adoption,” Hill said.

    A timeline for the test’s development and validation is currently being developed. Hill said that Oncimmune focuses on the major markets of the USA, Europe, and selected Asian markets, such as China. “All products would be launched through our current sales and marketing channels in these markets,” he reported.

    Image by Guillem Castro from Pixabay
  • Early Cancer Detection for the Developing World

    “Inclusive, impact-oriented, and scalable—Innovations in the developing world often need to be these three things for that deep penetration,” Mihir Shah, founder & CEO at UE LifeSciences, told attendees at MD&M Minneapolis 2019. He spoke during the Medtech Central stage presentation, “Women's Health Innovation for the Developing World,” on October 24.

    Such solutions “need to be massively scalable because of the numbers of people, and you’re usually dealing with highly dense populations. You are trying to build solutions that ultimately drive impact and outcomes,” Shah said. Solutions also have to be durable, high quality, and mobile, and they must be able to be used in a range of environments, he said.

    Shah and UE Lifesciences develop solutions for cancer early detection. “We are working toward building access to early detection, starting with breast cancer and cervical cancer,” he said. “Breast cancer is the number one cancer killer in women globally. And yet most of the world doesn’t have access to early detection.” He cited statistics that “7 out of 10 breast cancer deaths now come from the developing world,” adding that “these are low and middle income countries that most often don’t have mammographic screening programs. And 60% of cases that come forward are diagnosed late.”

    The company devised iBreastExam. “It is a device that is designed specifically for use in the developing world,” Shah told the audience. “It is a tiny probe, hand held, completely wireless, that enables a community health worker to perform a breast exam in a matter of 5 minutes and find areas of the breast that are stiff or hard—because that is what tumors are—they are harder or stiffer than normal breast tissue. You can use one of these devices with a companion mobile app. It can help a community health worker with very little training be able to offer a high-quality breast exam.”

    A validation study published in October 2016, “A cost-effective handheld breast scanner for use in low-resource environments: a validation study,” found that the iBreastExam “demonstrated excellent sensitivity . . . for the identification of clinically significant lesions in patients presenting for diagnostic imaging.”

    Shah shared further updates with MD+DI:

    • Two new studies (one from Brazil and another from India) will be presented at the global breast cancer meeting, the San Antonio Breast Cancer Symposium, titled "Clinical efficacy evaluation of a novel palpation imaging device for early detection of breast cancer in the developing world" and "Diagnostic accuracy of a novel palpation device to improve early detection of breast cancer in low-resource settings."
    • An implementation study titled "Health worker led breast examination in rural India using electro-mechanical hand-held breast palpation device" was published in the Journal of Cancer Prevention & Current Research on June 20, 2018. Study concludes that "training lay people on the use of the device could potentially provide screening to rural and underserved areas of under-developed nations where women historically have had no access to breast cancer early detection." 
    • Five international studies are underway currently including a study by Memorial Slone Kettering Cancer Center in Nigeria.

    iBreastExam is currently available in Mexico, India, Malaysia, Indonesia, Thailand, Myanmar, Oman, Botswana, and Nepal.

    UE Lifesciences’s next project entails coupling iBreastExam with a smart mobile colposcope called cervAIcal, in a portable kit, Shah said. “CervAIcal is being developed to provide AI-enabled screening for cervical cancer. Together, iBreastExam and CervAIcal can offer access to early detection for breast and cervical cancer, in a single visit,” he said.

    Image courtesy of UE Lifesciences
  • Web- and Mobile-Friendly Patient Registry

    The Metastatic Breast Cancer Alliance (MBCA) has begun a campaign to raise awareness and understanding of clinical trials in the metastatic breast cancer community ahead of releasing MBC Connect 2.0. MBC Connect is described as an interactive, web- and mobile-friendly patient experience registry that enables patients in the United States to collaborate with researchers and potentially be matched with clinical trials.

    “Depending on an individual’s cancer diagnosis, a clinical trial may be an excellent treatment option,” stated Shirley A. Mertz, a metastatic breast cancer patient and Chair of MBCA, in a news release. “As metastatic patients, we know that our current treatment will one day stop working, and we hope that another, more effective treatment, approved because of a successful clinical trial, will be available to us. The MBC Alliance’s launch of MBC Connect 2.0 makes it possible for every patient to easily identify trials that might be a fit for them and to be able to share those trials with their healthcare provider.”

    Added Elly Cohen, UCSF Assistant Professor of Surgery and Program Director at BreastCancerTrials.org (BCT): “Through carefully conducted clinical trials, researchers and patients work together to advance breast cancer care. Clinical trials give patients access to experimental therapies that researchers believe will be more effective than current treatments. Every patient should consider clinical trials as an option for care. MBC Connect 2.0 will help patients identify trials personalized to their situation that they can discuss with their providers when evaluating treatment options.”

    MBCA is partnering with BCT and Quantum Leap Healthcare Collaborative, its parent organization, to enable clinical trial matching on MBC Connect. BCT sources its clinical trial data from ClinicalTrials.gov. MBC Connect 2.0 will soon be available on Android and iOS devices, and via web browser, in both English and Spanish.

    Image by mcmurryjulie from Pixabay
  • Room-Temperature-Stable Fulvestrant Injection

    Fresenius Kabi is now offering a room-temperature-stable Fulvestrant Injection 250mg per 5mL prefilled syringe, which the company claims is the only form of Fulvestrant Injection to require no refrigeration.

    This new offering could help pharmacists save on the limited refrigeration space available to them, it was explained. “Fresenius Kabi is pleased to continue the expansion of our oncology portfolio by offering Fulvestrant Injection,” explained John Ducker, president and CEO of Fresenius Kabi USA, in a news release. “We are pleased to be the only company offering this product in a room temperature stable formulation to assist clinicians in managing their costs and workflow.”

    Fulvestrant Injection is indicated for the treatment of several types of breast cancers.

     

    Image courtesy of Fresenius Kabi
  • Genetic Testing

    The U.S. Preventive Services Task Force (USPSTF) is now recommending that primary care clinicians assess women with a personal or family history of breast, ovarian, tubal, or peritoneal cancer or who have an ancestry associated with BRCA1/2 gene mutations with an appropriate brief familial risk assessment tool. This recommendation statement was published in JAMA in August 2019 as "Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer." Those women who receive a positive result from that assessment should receive genetic counseling and, if indicated after counseling, genetic testing. (The USPSTF recommends "against routine risk assessment, genetic counseling, or genetic testing for women whose personal or family history or ancestry is not associated with potentially harmful BRCA1/2 gene mutations.")

    Myriad Genetics Inc. welcomed the recommendation. “We applaud USPSTF for recommending hereditary cancer risk assessment for all women with a family or personal history of certain types of cancers or who have an ancestry associated with BRCA mutations,” reported Royce T. Adkins, M.D., FACOG, board certified obstetrician-gynecologist and senior vice president of Medical Affairs, Myriad Women’s Health, in a statement. “There are more than 3.5 million breast cancer survivors who see their OB/GYN or primary care doctors annually. The valuable information provided by hereditary cancer risk assessment can help clinicians select appropriate precision treatments, customize treatment plans and achieve better health outcomes for their patients.”

    Myriad Genetics has offered hereditary cancer testing for more than 20 years, the company reported. Its myRisk Hereditary Cancer test evaluates 35 clinically significant genes associated with eight hereditary cancer sites including breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers, and melanoma.

    The personalized medicine company offers a variety of tests, including those that determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions, it reported. Recently, its BRACAnalysis Diagnostic System was granted a second manufacturing and marketing approval by the Japanese Ministry of Health, Labour, and Welfare to serve as a companion diagnostic with the PARP inhibitor, Lynparza. The approval enables "physicians to use BRACAnalysis to identify women with ovarian cancer who have a germline BRCA mutation and are eligible for first-line maintenance therapy with Lynparza," according to a news release. "BRACAnalysis previously was approved in Japan for use in patients with unresectable or recurrent breast cancer and is the only companion diagnostic test for a PARP inhibitor to receive regulatory approval in Japan."

     

    Image by PixLoger from Pixabay
  • New Survey Shines Light on Mammography Discomfort

    Siemens Healthineers and HealthyWomen, conducted results from a new national survey designed to deepen understanding on how to improve women’s experiences with screening mammograms for breast cancer detection. The survey, which included responses from women over age 40 (all of whom fall under the recommended screening guidelines), revealed that while 61% of women said mammograms are necessary, 52% found them uncomfortable and 25% regarded them as painful. Siemens Healthineers is working on changing the narrative and offers features such as low-lighting to make the experience more comfortable.

  • Reducing Repeat Surgeries

    OncoRes Medical is developing handheld, surgeon-operated imaging tools to increase surgical accuracy and more effectively identify and remove tumors during breast cancer surgery. The Australia-based company raised $6 million in 2017 from the Medical Research Commercialization Fund, and it was one of five finalists in the 2019 MedTech Innovator program, out of over 800 applicants. 

    In a video on the company's Web site, Dr. Katharine Giles, CEO and medical doctor, reports that 1 in 5 women who select a lumpectomy need "a repeat surgery as cancer is left behind."

    OncoRes "is developing a highly accurate handheld probe that translates a surgeon's sense of touch into a microscale image," Giles said. "Surgeons will use the probe inside the surgical cavity to identify tumor that has been missed. Let's help surgeons get all of the cancer out the first time." 

     

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