84% Sensitivity. 94% Specificity. 98% NPV.

American Society of Breast Surgeons (ASBS 2020)

3,247 women above 30 years of age participated following community outreach and awareness program. This is the largest independently conducted study undertaken by a highly reputed reference cancer center in southern India, as a community outreach and screening project, to report on the efficacy and acceptability of iBreastExam, when implemented in community-based, low-resource settings. Key highlights of the study are:

• Out of 3247 participants, iBreastExam identified 6.2% (203) as candidates for further evaluation.
• iBreastExam identified 15 women with a correlating BIRAD 4 score, of which 3 were confirmed as early stage breast cancers (Stage IIA, IA and DCIS), none with palpable abnormality on clinical breast examination (CBE).
• 97% of the participants reported the test as acceptable and recommendable to relatives and 98% expressed an interest to have iBreastExam made available at local Public Health Centers.

American Society of Clinical Oncology (ASCO 2020)
486 women, US based study titled "Clinical Utility of a Hand-Held Scanner for Breast Cancer Early Detection and Patient Triage" conducted independently by leading cancer researchers (Drs Brooks, Englander, Anderson, Rositch) to assess whether iBE can be used to reduce the pool of women who need follow-up and diagnostic services by correctly screening out women with normal mammograms without missing patients with clinically significant invasive cancers. Key Discussion Points:

• When used as a triage test, iBE may improve the subsequent performance of mammography by decreasing the pool of true negatives that are imaged. Triage in LMICs is important because widespread mammography is not financially or infrastructurally feasible.
• The iBE versus CBE comparison, however, is promising in the context of a growing need for additional triage mechanisms in resource-limited settings.
• This result supports the use of iBE as an adjunct triage tool to reduce the number of patients referred for imaging, particularly in countries in which widespread screening mammography for all is not realistic.

San Antonio Breast Cancer Symposium (2019)

P1-01-06 Diagnostic accuracy of a novel palpation device to improve early detection of breast cancer in low-resource settings.

In a 1200 women, India based prospective non-interventional study,

• iBreastExam demonstrated significantly (23%) higher sensitivity and moderately (9%) higher specificity to detect breast lesions as compared to CBE.

• Lower FP rates compared to CBE reduces the pool of women requiring further diagnostic follow-up.

• iBreastExam requires minimal training and provides objective breast examination with digital documentation.

• iBreastExam may enable community health worker led triaging to detect clinically relevant breast lesions in LMIC settings.

San Antonio Breast Cancer Symposium (2019)

P1-01-01 Clinical efficacy evaluation of a novel palpation imaging device for early detection of breast cancer in the developing world.

Key conclusions from 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 iBE to strengthen breast cancer early detection programs in LMIC’s and support the need for next generation sensors with improved sensitivity.

Journal of Cancer Prevention & Current Research (2018)

1200 women, Implementation study titled "Health worker led breast examination in rural India using electro-mechanical hand-held breast palpation device" 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."

World Journal of Surgical Oncology (2016)

Clinical study titled "A cost-effective handheld breast scanner for use in low-resource environments: a validation study" published in the World Journal of Surgical Oncology on Oct 28, 2016. iBE correctly identified 66 lesions demonstrating sensitivity of 86% and specificity of 89%.

Indian Journal of Gynecologic Oncology (2016)

A major clinical study with 916 women enrolled, evaluating iBE™ technology was published in the Indian Journal of Gynecologic Oncology in June 2016. The study showed that iBreastExam device can significantly enhance clinical breast examination Sensitivity (by 19%) while maintaining high Specificity (94%) and Negative Predictive Value (NPV) of 98%. The study concluded that iBreastExam can be a promising tool for early detection of clinically relevant lesions at early stages and also useful in younger women with dense breasts.

Journal of the American College of Surgeons (2013)

The first clinical study evaluating iBE technology was published in the Journal of the American College of Surgeons (Volume 216, Issue 6, Pages 1168-1173, June 2013). This study demonstrated that iBE technology could confidently detect invasive lesions/tumors that the physician could not feel with his hands (meaning non-palpable lesions). iBE also performed very well in the younger age group (below 40) in detecting small masses.