ACAP HealthWorks, a subsidiary of Holmes Murphy, has partnered with the makers of early breast cancer detection technology Bexa™ to provide employers with tools to improve their wellbeing programs.
Bexa™ (previously known as SureTouch) is a Class II U.S, Food and Drug Administration (FDA-) cleared (K181672) medical device currently indicated for the documentation of abnormal breast tissues and masses discovered on a breast examination. The device is developed by Sure, a physician-led company that develops and manufactures the device and owns and operate the company’s SureView™ system, a secure, HIPAA/HITECH-compliant, cloud-based ecosystem which provides device management and continuous quality monitoring.
Pressure-based elastography
The technology behind the Bexa™ breast cancer exam is based on measuring the elasticity, of both malignant and benign tissues. This elasticity enables tissue to be deformed when it is subject to an external force and then resume its original shape or size when that force is removed. By measuring these unique elastic properties (i.e. comparing how firm or stiff specific tissues are compared to surrounding tissue), physicians can diagnose pathologic changes in tissues and discriminating between malignant tumors and benign tissue. [1]
Tissue deformation or elastic property is inversely proportional to the stiffness of a specific tissue, while the response time (i.e. the time it takes return to its natural condition) varies as a function of the histotype. [2] For example, adipose tissue is more easily deformed, while fibrous tissue returns to the initial condition more slowly than adipose or muscle tissue. [3]
Elastography is based on this understanding and the assumption that cell density is increased in most solid tumors. Research has shown different coefficients of elasticity in normal and neoplastic breast tissue, with benign nodules being more deformable, whereas malignant lesions tend to be harder or stiff. By assesses the deformation or relative elasticity of all tissues (adipose, fibrogland and cystic or solid lesions) in a specific area of interest, physicians can identify abnormal stiffness. [4][5]
This technology may reduce the need for biopsy in small lesions and has a significant role in the management of nodules <5 mm which are visible on an ultrasound image, but not on mammography, in which reduced deformability may lead to biopsy rather than monitoring as required by the current guidelines.
A sense of touch
The Bexa technology, generally referred to as pressure-based elastography, enables the detection of malignant tissues and organs by evaluating their elastic properties and gives physicians quantitative and reproducible information on solid breast lesions with diagnostic accuracy, allows for high sensitivity (typically ≥90%) characterization of breast abnormalities. [4][5]
Originally developed in 1997 by Jae Son, Ph.D., an entrepreneurial inventor and engineer, and founder of Pressure Profile Systems (PPS), the technology revolutionized tactile sensing technology and harnessed the sense of touch for medical devices, including breast scanning technologies.
How it works
Using an advanced, proprietary capacitive sensor array designed to collect data about abnormal tissues based upon their elastic nature, Bexa, maps breast masses as small as 5 mm. The differences in tissue elasticity are captured digitally when device’s sensor array is moved gently across the surface of the breast.
Because underlaying technology is measuring the elasticity of tissues, it is not affected by ‘breast density.’ As a result, the device produces a low number of false positive results, and is accurate in younger women who fall outside the guidelines for mammography developed by the United States Preventive Services Task Force (USPSTF)*, an independent panel of experts in primary care and prevention that systematically reviews the evidence of effectiveness and develops recommendations for clinical preventive services.
The handheld medical device provides a convenient, painless, and radiation-free strategy for the early detection of breast cancer and can be used by healthcare professionals as well as on-site at an employer’s location by a trained examiner, while any masses or lumps found during breast exam are immediately evaluated with B-mode ultrasound, adding critical data to the evaluation and classification of abnormal breast tissues, and dramatically reducing an already low need for additional imaging studies.
Importance of Early detection
Survival of breast cancer differs substantially by stage at diagnosis. Hence early-stage cancer detection remains key in significantly reducing breast cancer death rates. [6] If breast cancer is found early, more treatment options are available, improving the change of survival. If cancer is detected in early, the chance of five-year survival is greater than 93%. If detected in later stage, the chance of five-year survival is reduced.
However, in the United States, less than 40% of eligible woman opting in to receive annual mammograms.
Joe Peterson, MD, Chairman and Chief Executive Officer of Sure, the developer of Bexa™.“We know approximately 60% of eligible women are missing their annual mammogram due to fears of pain, radiation, intimidating clinical settings, and lack of time and resources,” said Bailey Ballsrud, Chief Operating Officer, ACAP HealthWorks.
Other issues resulting in the lack of annual screening may be based on racial, social and economic disparities, caused by an interplay of many factors, including social determinants of health, behavior, biology, and genetics. [7]
“We’re focusing on the lack of both participation in and access to early detection options, a quiet but very real tragedy,” said Joe Peterson, MD, Chairman and Chief Executive Officer of Sure.
“Globally 90% of women have no technology-assisted early detection option. That’s 1.3 billion women with little chance to beat the most common women’s cancer,” Peterson added.
“Here, in the United States, based upon insurance claims data, which represents a real good measure of reality, fewer than 40% of women have an annual exam, which includes a mammogram, ultrasound or other diagnostic procedure, beginning at age 40. And that while ‘every year beginning at age 40‘* remains the most effective regimen and is endorsed by leaders in every clinical specialty that deals with breast cancer,” Peterson further noted.
Impact of covid on screening
The COVID-19 pandemic has greatly affected mortality and morbidity and disrupted access to timely cancer-related services, incuding early diagnosis. And while most health services have been strained as a result of COVID-19, many population breast mammography screening options designed to diagnose and treat breast cancers earlier have been paused or have seen their capacity reduced. In turn, the resulting delays of diagnosis and treatment may lead to more intensive treatment requirements and, potentially, increased mortality later. [8]
“Within these broad populations are women in rural and low-income settings who frequently set aside self-protection because of a lack of resources, access or the income insecurity caused by time-consuming processes.”
African American women have a disproportionate burden of aggressive young-onset breast cancer and timely detection and treatment is a major factor in optimizing survival and minimizing recurrence.
“Especially African American women, who are commonly being diagnosed 3 to 4 years earlier than white or hispanic women, should start screening at age 35.”[9]
“It’s the critical factor in determining the suffering and death, and cost produced by invasive breast cancers. There’s no surgery, no drug, no therapy that makes up for the impact of a breast cancer being diagnosed late that may have been able to be diagnosed early.”
Importance of partnership
“We have to do better, which is why this partnership [with Sure is really] important to us. We believe [that the] Bexa [-technology] is going to be an important part of the healthcare world for years to come, and the mission and innovation behind this technology is very much in sync with our commitment to providing better health solutions at ACAP and for the employers we work with,” Ballsrud noted.
“We believe in offering solutions to employers as they work to ensure their employees have the best access to care and benefits possible. No doubt, Bexa will revolutionize the breast exam space and encourage women to be proactive rather than reactive,” she concluded.
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Note: *Based on the recommendation of the United States Preventive Services Task Force (USPSTF), asymptomatic women aged 40 years or older who do not have preexisting breast cancer or a previously diagnosed high-risk breast lesion and who are not at high risk for breast cancer because of a known underlying genetic mutation (such as a BRCA1 or BRCA2 gene mutation or other familial breast cancer syndrome) or a history of chest radiation at a young age. The USPSTF recommends biennial screening mammography for women aged 50 to 74 years, while the decision to start screening mammography in women prior to age 50 years should be an individual one.[10]
Clinical trials
Assessing the Sensitivity of “SureTouch™” in Women Undergoing Diagnostic and Screening Mammography – NCT04397029
Reference
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[2] Nightingale K, Soo MS, Nightingale R, Bentley R, Trahey G. In vivo demonstration of acoustic radiation force impulse (ARFI) imaging in the thyroid, abdomen, and breast. 2001 IEEE Ultrasonics Symposium. Proceedings. An International Symposium (Cat. No.01CH37263), Atlanta, GA, USA, 2001, pp. 1633-1638 vol.2, doi: 10.1109/ULTSYM.2001.992035.
[3] Nightingale K, Too MS, Nightingale R, Bentley R, Stutz D, Palmeri M, Dahl J, Trahey G. Acoustic radiation force impulse imaging: remote palpation of the mechanical properties of tissue,” 2002 IEEE Ultrasonics Symposium, 2002. Proceedings., Munich, Germany, 2002, pp. 1821-1830 vol.2, doi: 10.1109/ULTSYM.2002.1192652.
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[7] Farley TA, Flannery JT. Late-stage diagnosis of breast cancer in women of lower socioeconomic status: public health implications. Am J Public Health. 1989 Nov;79(11):1508-12. doi: 10.2105/ajph.79.11.1508. PMID: 2817162; PMCID: PMC1349803.
[8] Breast Screening Working Group (WG2) of the Covid-19 and Cancer Global Modelling Consortium; Figueroa JD, Gray E, Pashayan N, Deandrea S, Karch A, Vale DB, Elder K, Procopio P, van Ravesteyn NT, Mutabi M, Canfell K, Nickson C. The impact of the Covid-19 pandemic on breast cancer early detection and screening. Prev Med. 2021 Oct;151:106585. doi: 10.1016/j.ypmed.2021.106585. Epub 2021 Jun 30. PMID: 34217412; PMCID: PMC8241687.
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[10] Siu AL; U.S. Preventive Services Task Force. Screening for Breast Cancer: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2016 Feb 16;164(4):279-96. doi: 10.7326/M15-2886. Epub 2016 Jan 12. Erratum in: Ann Intern Med. 2016 Mar 15;164(6):448. PMID: 26757170.
