I-Corps: Early Detection of Recurrence for High-Risk Breast Cancer Patients

Award ID: 2022576

The broader impact/commercial potential of this I-Corps project is to improve the well-being of women at-risk for breast cancer (BC) recurrence. BC is a leading cause of death for women in the United States and a substantial contributor to decreased quality of life. Each year, more than 250,000 American women are diagnosed with BC and an estimated 30% of BC patients will experience a recurrence within 5 years. Though methods exist to approximate the risk of recurrence, there is no way to determine if and when a patient will experience a recurrence. When BC advances to a late stage, there is a decrease in quality of life characterized by distressing pain, depression, and a 30-70% loss in walking capacity, balance, and physical strength. Economically, the cost of care for late stage BC is 2-fold greater than early stage, and it imposes an economic burden of $12 billion per year in lost productivity and healthcare costs. The commercial development and clinical deployment of the proposed device which monitors for BC recurrence would enable therapeutic interventions at life-preserving timescales. This would preserve patient health, provide peace-of-mind, and relieve financial strain resulting from reactive, late-stage care. This I-Corps project proposes an implantable system for monitoring and measuring markers of health and disease in a way that is fundamentally distinct from methods used clinically today. A small microporous biomaterial implant has been developed that sits beneath the skin and enables the monitoring of cancer recurrence. Extensive research has demonstrated that the proposed implants become vascularized and collect immune cells. In mouse models of cancer, changes in the cell composition and gene expression of the implant can be used to monitor and diagnose cancer recurrence. The team has demonstrated the non-invasive monitoring of cancer biomarkers as a means of providing high-value diagnostic data. This new method for early detection of BC recurrence represents an improvement over the status quo and emerging liquid biopsy technologies. Currently, recurrence is diagnosed when symptomatic and by mammography - both limited to sizable tumors greater than 0.5 cm. Liquid biopsies that measure cancer DNA in the blood have low sensitivity and are only capable of detecting breast cancer at a sensitivity of 10% (at 98% specificity) in patients already diagnosed by mammography. The proposed implant would continuously monitor for biomarkers of cancer recurrence to enable the diagnosis and treatment at timescales that extend survival. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

NSF Program Director: Ruth Shuman