SBIR Phase I: Breast Cancer Risk Test for Atypical Hyperplasias

This Small Business Innovation Research (SBIR) Phase I project proposes to develop a breast cancer risk test for women who are diagnosed with breast atypical hyperplasias. Atypical hyperplasias of the breast are not cancers but are very high risk precancerous growths. Several studies have established that about 20-25% of women diagnosed with atypical growths subsequently develop breast cancer in 1-5 or more years. However, there are no tests currently in the clinic to distinguish 20-25% of atypical group of women who are most likely to develop breast cancer from 75-80% of low risk group. Lack of any tests has posed a dilemma for clinicians in selecting candidates for treatments and preventing breast cancer development among women with atypical hyperplasias. This Phase I project will test the feasibility of developing a clinical test based on the biology of atypical hyperplasias. The test could be applied to screen women who are most likely to develop breast cancer so that they can be treated prophylactically and prevented from developing breast cancer. The broader impact/commercial potential of the project could the be prevention of about 20,000 breast cancers per year among the high risk group of women with atypical breast hyperplasias. By preventing significant number of breast cancers at the precancerous stage, billions of dollars can be saved per year in health care costs. The test under development should also increase the quality of life and survival of women who suffer atypical hyperplasia Surveys have shown that about 100,000 breast atypical hyperplastic cases are diagnosed per year in the USA alone therefore about 100,000 tests could be performed per year in the USA. The target population for commercializing the test will be breast surgical oncologists, medical oncologists who administer prophylactic therapies and to some extent pathologists who send tissue samples for testing.