Clinically Proven. US FDA Cleared.

Award Winning Innovation.

The Lancet Global Health Article by Victoria Mango and colleagues used the portable iBreastExam, a handheld screening device, to evaluate women aged 40 years or older who were symptomatic or at high risk with a family history of breast cancer. They compared the iBreastExam with clinical breast examination performed by experienced surgeons and used imaging (mammography or ultrasound) as a reference standard. To our knowledge, this type of study was the first in Nigeria and possibly in Africa.

The independent review concluded that:

• The iBreastExam can overcome the issue of a shortage of specialists for early detection of breast cancer in Nigerian communities, thus showing the potential to reduce incidence of advanced stage breast cancer and might lead to improvement in survival.
• In conclusion, the study shows that with minimal training, inexperienced health-care providers can use the iBreastExam successfully and achieve higher sensitivity than with clinical breast examination.

19,583 women enrolled over 2 years by Governmental Medical College in Nagpur, India, with a mean age of 36 years. 62.42% females came for screening, 31.16% females presented with lump in the breast and 6.42% females with pain in the breast.

• iBreastExam shows significantly better sensitivity and higher specificity and was found to be a promising effective tool for younger women with dense breast.
• It is highly cost-effective in terms of maintenance of the device, transport of females to tertiary center, reducing patient load for physicians and workload for machines and radiologists.
• iBE is the first modality providing results at point-of-care and making females anxiety free, who came for screening with normal breasts.

Key conclusions from an independent study in a Brazil based study of 226 women (449 breasts analyzed independently),

• The relatively high specificity highlights the tools’ ability to reduce the pool of women warranting further evaluation but the sensitivity of iBE compared to mammography alone was relatively low.
• 15 of the 17 cases identified as normal by iBE were classified as BIRADS 0. When these cases underwent US, the net sensitivity increased to 74%.
• Based on the acceptability survey, iBE shows extreme promise and demonstrates high approval among women
• These data highlight the potential for iBreastExam to strengthen breast cancer early detection programs in LMIC’s and support the need for next generation sensors with improved sensitivity.

916 healthy women visiting Manipal Hospital, Bangalore, for annual health check were recruited for bilateral breast examinations. Additionally, 20 women attending the hospital with breast-related symptoms were also recruited as part of the opportunistic screening program. Each woman was examined by three independent methods, each blinded to the other two: iBreastExam (iBE), Clinical Breast Examination (CBE) by an expert clinician and Breast Imaging (mammography or breast ultrasound).

• iBreastExam) performed with significantly better sensitivity, by 19 %, than CBE to detect breast lesions while reporting high specificity (94 %) and NPV (98 %).
• In younger women population under the age of 40 years, where the prevalence of dense breast is high, iBreastExam demonstrated high-performance characteristics.
• iBreastExam detected all malignant lesions in this study, while the clinician’s CBE missed to detect a non-palpable malignant lesion.
• iBreastExam can be a promising tool to provide clinically effective and standardized breast examinations in low-resource settings to detect breast lesions at early stages. The device can also be an effective screening tool for younger women with dense breasts.

It would be a win-win situation for all parties involved if the government of Nepal would seriously consider introducing, implementing, and incorporating screening examinations such as iBreastExam and other similar tools to improve early detection and reduce the undesirable and unfortunate breast cancer–related mortalities.

Link: DOI: 10.1200/GO.22.00216 JCO Global Oncology no. 8 (2022) e2200216. Published online September 1, 2022.

1,200 asymptomatic women (2,400 breasts) with median age of 43 years were examined by clinical breast exam and iBreastExam

• Compared to Clinical Breast Exam, iBreastExam demonstrated significantly (23%) higher sensitivity and moderately (9%) higher specificity to detect breast lesions.
• Given that iBE requires minimal training and provides objective breast examination with digital documentation; better performance than clinical exam highlights the tools’ utility as a triaging tool by identifying women in need for follow-up diagnostics.
• iBreastExam may enable community health worker led triaging to detect clinically relevant breast lesions in LMIC settings.

424 Nigerian women with median age of 46 years that were either symptomatic or at high-risk for breast cancer, were enrolled.

• iBreastExam by recent nursing school graduates has shown a high NPV and sensitivity for identifying women with suspicious breast lesions, as defined by imaging, but lower specificity than a surgeon's clinical breast examination.
• In geographical locations where clinical breast examination by experienced practitioners is unavailable, the iBreastExam might fill this gap by providing a high sensitivity breast evaluation tool in the community health setting.

Independent clinical study published in the World Journal of Surgical Oncology in Oct 2016. iBreastExam correctly identified 66 lesions demonstrating sensitivity of 86% and specificity of 89%.

Link: Peer Reviewed Publication, Full Text

Independent clinical study published in the World Journal of Surgical Oncology in Oct 2016. iBreastExam correctly identified 66 lesions demonstrating sensitivity of 86% and specificity of 89%.

Link: Peer Reviewed Publication, Full Text