iBreastExam (iBE) is the world’s first handheld, radiation free, cloud connected breast scanner which enables early detection of lesions through a standardized, clinically effective breast examination. The test is completely painless & radiation-free, takes <5 minutes and provides results instantly at the point-of-care, even in low resource environments.
This cost effective breast health test can be offered to women of all ages, at $1 per scan and stands to benefit 1 billion women worldwide.
Painless & radiation-free breast health exam device for use by CHWs to detect early signs of breast cancer affordably at the point of care.
What problem are you trying to solve?
With 1.7M new cases and 522,000 deaths, breast cancer is the most common women’s cancer globally. In developing regions, over 60% of cases are detected at late stages with poor prognosis. 5-year survival is ~50% in these parts vs. 90% in developed countries. Screening improves early detection of cancers by 1.5-2.5 times. Gold standard for screening, (mammography) is clinically limited in women < age 50 (due to dense breast), expensive, requires trained radiologists to interpret images, culturally unfriendly due to pain and radiation and inaccessible to BoP. Clinical Breast Exam (CBE) and Self Breast Exam (SBE) are high subjective, offer low sensitivity and have clinical limitations in detecting non-palpable lumps at early stages and have had limited clinical success. UE LifeSciences is solving this problem to create effective, affordable, scalable and social acceptable access to breast cancer early detection for women in the developing world.
What is your solution to this problem?
iBreastExam (iBE) uses a patented piezoelectric sensor technology to distinguish harder breast tumors from normal breast tissue, in real time, at the point of care. Paired with a mobile app, iBE enables a community health worker to provide standardized, objective and an effective breast examination to detect breast lumps at an early stage, affordably. iBE is the first of its kind, clinically validated (85% sensitivity, 94% specificity, 98% negative predictive value), US FDA cleared and European CE marked, hand-held, non-invasive and radiation-free connected device. iBE senses non palpable lumps, making it more effective than CBE. The device does not require highly trained medical experts for test administration or interpretation. The test is suited for all women, in virtually any setting, with highly limited infrastructure.
What is your latest update on your innovation?
To date over 150,000 have received an iBreastExam test in 8 countries and over 100 cases of breast cancer have been confirmed with the help of an iBE test. UELS has various confirmed projects that will bring iBE to an 500,000 women in the next 12 months. Through a strategic partnership announced with GE Healthcare in Nov 2017, iBE is being available in more than 25 countries across Africa, South Asia and Southeast Asia. iBE has been evaluated under 3 clinical studies with over 3000 women enrolled – published studies demonstrate high-performance characteristics. iBE is now commercially available in India, Nepal, Oman, Botswana, Indonesia and Mexico and has been market cleared by several regulatory bodies including US FDA, CE Mark, COFEPRIS and Myanmar FDA. iBE has been received a number of international innovation awards and has featured on TED Talks and other media outlets.
Why are you going to win the Best Innovation for Development Award?
While breast cancer is the leading site of cancer in women globally, there are practically no solutions in place to cause early detection in a scalable and socially and culturally acceptable way. Over 1B women are in need for routine breast health examination. With iBreastExam, UELS is addressing this large, clinical need and hopes to improve survival rate. iBE has already demonstrated scale (150,000 women screened), feasibility ($1 per scan) and high-efficacy (85% sensitivity, 94% specificity).