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.
One of the major public health problems in the USA has been breast cancer. It continues to be the second leading cause of cancer deaths for women becuase of our limited success in completely curing once it develops. We can expect a reduction in the incidence and deaths if we can detect at a treatable stoppble precancerou stage. One of the high risk groups recognized is atypical precancerous group. Surveys have shown that about 100,000 breast atypical cases are diagnosed per year in the USA and 1 in 4-5 women subsequently develops breast cancer in this group. Currently there are no tests for preciserly stratifying the 20,000-25,000 high risk women who are most likely develop breast cancer from 75,000-80,000 low risk women. Lacks of any tests posed a dillema for clinicians as well as patients in undertaking preventive measures. We recognized a business opportunity in a test for stratifying high risk from low risk group. In Phase I we have established the feasibility of a breast cancer risk test that can stratify high risk group from low risk group based on the presence of multple cancer markers in atypical tissues. We have establsihed the risk scores in high risk and low risk groups. Our Test predicts the likelihood of developing or not developing breast cacer for women diagnosed with breast atypical hyperplasias. Once fully developed in Phase II and implemented in the clinic, it could be applied as a screening tool to precisely stratify high risk women from low risk group so that the high risk will have an option to undertake preventive treatments similar to BRCA gene mutation carriers and stop developing in the first place. The test volume per year will be 100,000 and will generate about $6Million per year in revenue. In addition, the screening test under development will have a major impact in stopping 20,000-25,000 breast cancer per year in the USA and saving $Billions per year in the helath care cost similtaneously sparing women from torturous suffering and potential death. In addition, the Test under development will aid in evaluating the efficacy of various breast cancer preventive treatments, and development of biomarker based breast PapTest to detect tumor-in-formation state in women who have mammographically undetectable growths.
