SBIR Phase I: Predictive ex vivo solid tumor biopsy-chip multiplexer for screening anticancer agents

Cerflux, Inc., Birmingham AL

Investigators

Abstract

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project lies in enhancing health outcomes and quality of life for cancer patients. Each year, over 1.7 million Americans are diagnosed with cancer, and treatment turns out to be ineffective for approximately 75% of those receiving systemic therapy. This failure is because every tumor is distinct in makeup and response to treatment. Unfortunately, a generalized treatment approach is forced upon a disease that is uniquely personal due to lack of personalized predictive tools. Consequently, patients are exposed to several rounds of potentially harmful overtreatment until the right regimen is found. Adding insult to injury, over 40% of patients deplete their entire life savings in just 2 years. In discussions with leadership from the Centers for Medicare & Medicaid Services (CMS) and private insurance providers – who currently spend over $35 billion annually on treating just five types of cancer – the inability to match treatments to tumors was unanimously the critical, unmet, and urgent market need. This proposal can make a profound impact on the lives of cancer patients, offer substantial cost savings to insurance providers, and strengthen US leadership in advanced research. This Small Business Innovation Research (SBIR) Phase I project represents a major departure from the traditional, one-size-fits-all approach to cancer treatment. The proposed technology will rapidly match biopsy tissue from a patient’s tumor with various treatment regimens – before treatment, outside the patient – to identify the right treatment for that patient. In order to achieve clinical translation for this technology, during this SBIR Phase I project, the company will address several key objectives: 1) establish standard guidelines for tissue collection, handling, and cold chain logistics to minimize the impact of these factors on the viability of live solid-tumor biospecimens; 2) generate 3D bio-printed mimics of patient biopsies for extensive validation and refinement of the technology; and 3) demonstrate the predictive capacity of this platform for personalized cancer treatment. If successful, this personalized approach will not only reduce the cost of cancer treatment incurred by health insurance providers but, more importantly, also lighten the emotional, physical, and financial burden suffered by patients. 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.