screening with confidence
Routine mammography is an accepted procedure for breast cancer detection that is relatively available for most women. However, as a screening tool for breast cancer it has its drawbacks including:
- Significant discomfort during the process
- Frequent false positive results that lead to increase anxiety associated with possibility of cancer
- Unnecessary follow-up procedures such as invasive biopsies.
Together, these factors led to screening hesitance in the target population.
The overarching goal of INTERCEPT is to provide a first-line screening tool that can complement or substitute for mammography using a simple laboratory blood draw that can achieve higher accuracy for detecting breast cancer at its earliest stages while being more readily available with less discomfort. Our plan is to initiate the INTERCEPT clinical study in 2023.
If you are interested in participating in this research program, please JOIN INTERCEPT!
Early Detection leads to Better survival
How is the Test Relevant to you
The INTERCEPT test is a blood test, with blood drawn locally, analyzed by our laboratory, and once validated, the data will go to your doctor and will eventually be shared with you. You will become part of this research and the future that will impact you and your loved ones. JOIN INTERCEPT!
INTERCEPT is our next study in early breast cancer detection and assessment. INTERCEPT is being designed as an observational study for women over 40 years of age and all women and men at increased risk of breast cancer. We are currently working on the clinical study protocol and will update you with information about initiation of the study as soon as possible (Click this JOIN INTERCEPT link).
DIGITAL HEALTH COMPONENT
Blood based cancer screening is ideally suited for widespread distribution to the community, but neither the companies who promote these tools nor health systems have the information technology infrastructure for communicating results and tracking people who were screened this way. We are working with Cansera, Inc. who is building smartphone based digital tools that will facilitate community-based cancer screening using a blood test. The key technology objectives are to design a patient registry to support the personalized screening pathway approach, implement expanded capabilities for standard of care, patient generated healthcare data and liquid biopsy data, and demonstrate high fidelity end-to-end execution. The proposed INTERCEPT offering wraps the liquid biopsy-derived biomarkers in a digital health framework as a direct solution to address the lack of appropriate follow-up for abnormal results in traditional screening pathways.
About the SciencE
We have been developing liquid biopsy approaches (using blood from a simple blood draw) to help treat cancer for many years via the HDSCA (High-Definition Single-Cell Assay) Discovery Platform. The third-generation, multi-modal liquid biopsy platform has the goal of maximizing the amount of information that can be extracted from a sample. It allows for the detection and characterization of CTCs and other rare cell types and acellular structures (e.g., oncosomes) using immunofluorescence imaging coupled with single-cell genomic profiling and targeted multiplex proteomic evaluation, along with parallel analysis of cell-free DNA, exosomes, and bulk proteome from plasma. This allows for a broad description of circulating disease with a robust and objective analytical framework for the identification and characterization of rare cells with epithelial, endothelial, mesenchymal, and immune markers to delineate the biology of the cancer.
We have recently expanded our research into a liquid biopsy-based diagnostic tool for early breast cancer detection. Specifically, we have developed a method to detect both rare disease-related cells as well as oncosomes which are extracellular vesicles shed from cancer cells. Including both analytes in the analysis is particularly effective at distinguishing normal blood donor samples from breast cancer samples with sensitivity and specificity greater than 90%.
Using the HDSCA platform, we have developed a workflow to enroll participants in a screening approach and obtain a blood sample which is sent to and processed at the USC laboratory in Los Angeles. The samples are then imaged and analyzed to detect the rare events and oncosomes and that data is integrated with the participant’s clinical information. This workflow is being optimized for the INTERCEPT study described below.
Check out our latest publication in npj Breast Cancer, Multianalyte liquid biopsy to aid the diagnostic workup of breast cancer.
Here is our earlier published work in Cancers on Large Extracellular Vesicle Characterization and Association with Circulating Tumor Cells in Metastatic Castrate Resistant Prostate Cancer.
Blog post in nature portfolio: Hiding in Plain Sight: Early, nano-sized signs of breast cancer detected by liquid biopsy
Blog post at the Breast Cancer Research Foundation’s website: New Liquid Biopsy Technique May Help Personalize Breast Cancer Diagnosis and Prognosis | BCRF
Blog post at the Breast Cancer Research Foundation’s website: Investigating Breast Cancer: Dr. Peter Kuhn | BCRF