BIOFLUIDICA, INC. — Department of Health and Human Services SBIR Phase I: NIBIB

Description

DESCRIPTION provided by applicant Epithelial Ovarian Cancer EOC is the th leading cause of cancer related deaths among women in the US and is the leading gynecological cancer killer with cases reported in EOC has been called a andquot silent killerandquot because most women andgt are diagnosed at late stages of disease due to a lack of clinically sensitive and specific screening test and a lack of symptoms until late stage disease onset While the incidence rate of EOC in the US is highest among white females there exists a dramatic disparity in post diagnosis outcomes in other populations with African American women exhibiting substantially greater mortality based on year survival rates A combination of insufficient early detection strategies as well as reduced access to surgical treatment required at later stages of disease appears to contribute to the disparity Improved access to advanced screening assays and thereby earlier detection is therefore urgently needed to improve outcomes particularly in disparately effected populations Analysis of circulating tumor cells CTCs from cancer patientsandapos blood have demonstrated prognostic value in metastatic cancers but the use of CTCs for diagnosing early stage disease requires a degree of sensitivity and specificity currently unavailable in existing CTC analysis technologies An innovative CTC detection technology will emanate from this SBIR research project that will have unique capabilities suited to the early detection of EOC and potentially other cancers as well The technology uses low cost disposable plastic CTC fluidic cartridge that possess the ability to select CTCs directly from whole blood with extremely high recoveries andgt unprecedented purities andgt and can enumerate the captured CTCs using a label less approach with a simple single cell transducer micro CTC Coulter Counter C The technology provides a simple workflow with full process automation ideal for a screening test that can be utilized within resource limited settings The technology will process whole blood directly mL input and affinity select the CTCs release the CTCs from the capture surface and count them using an on chip C Unique to our platform is the ability to select different CTCs subpopulations from a single sample BioFluidica has tested its capture system using a novel CTC isolation antigen which as the preliminary data indicates is more prevalent in early stage disease compared to the more commonly used selection target epithelial cell adhesion molecule EpCAM The ability to capture multiple stage specific CTC subpopulations has the potential to diagnose patients at early stages of disease as well as assess treatment efficacy and the potential for disease recurrence The goal of this proposal is to initiate the development of a powerful EOC screening test accelerating treatment and improving currently poor prognoses especially in disparately affected African American women Successful completion of this Phase I program will provide the impetus to move the technology into early detection scenarios for other cancers that show disparities such as breast cancer in African American women PUBLIC HEALTH RELEVANCE Epithelial ovarian cancer EOC exhibits the th highest mortality rate amongst women in the US While its incidence rate is higher among white women epidemiological data reports a significant reduction in the year survival rates for African American women While new screening assays are broadly required to detect early stage disease an automated cost effective and accurate test has the best chance of improving the disparate mortality rates in various populations This project is focused on developing a transformative technology that can serve as a screening test which isolates circulating tumor cells CTCs from blood samples to diagnose early stage EOC appropriate for ethnic groups with EOC health disparities