The multi-gene expression assay measures anti-tumor immune response (MHCII) to generate a quantitative Immune Activation Score to assess an individual patient’s risk of recurrence and predict their response to therapy.

TNBC survival rate is worse than other breast cancers, with no available diagnostics to assess the risk of recurrence that could inform treatment plans and potentially improve outcomes.

Triple negative breast cancer (TNBC) is a form of invasive breast cancer that does not express receptors for the three standardly used markers in breast cancer prognosis: Estrogen, Progesterone, and HER2. Roughly 15-20 percent of all diagnosed breast cancers are TNBCs. Approximately 60 percent of TNBC patients experience long term disease-free survival after standard treatment, but the remaining 40 percent experience a relapse of the disease. An immune activation assay has been developed to provide a robust measurement of a specific type of anti-tumor immune response (MHCII) that is associated with a lower probability of recurrence, better overall prognosis, and response to immunotherapy. The measured expression of a panel of genes is compatible with formalin-fixed paraffin embedded clinical tumor specimens. The classifier algorithm generates a quantitative Immune Activation Score that can be used to assess an individual patient’s risk of recurrence and predict their response to therapy. Preliminary data supports the prognostic and predictive utility of the assay in triple negative breast cancer, HER2 positive breast cancer, ovarian cancer, lung squamous cell carcinoma, and melanoma.

Pre-Clinical Validation

• Score quantitatively correlates the probability a TNBC patient will experience disease recurrence/relapse.
• More information about the anti-tumor immune response than measuring single genes or proteins.
• More quantitative over a larger dynamic range than traditional immunohistochemical assays.
• Compatible with formalin fixed paraffin embedded tissue and other commonly available clinical tumor specimens .
• Predicts prognosis and response in HER2+ breast cancer, ovarian cancer, lung squamous cell carcinoma, and melanoma.

Stewart, R. L., Updike, K. L., Factor, R. E., Henry, N. L., Boucher, K. M., Bernard, P. S., & Varley, K. E. (2019). A Multigene Assay Determines Risk of Recurrence in Patients with Triple-Negative Breast Cancer. Cancer research, 79(13), 3466–3478. https://doi.org/10.1158/0008-5472.CAN-18-3014

Stewart, R. L., Matynia, A. P., Factor, R. E., & Varley, K. E. (2020). Spatially-resolved quantification of proteins in triple negative breast cancers reveals differences in the immune microenvironment associated with prognosis. Scientific reports, 10(1), 6598. https://doi.org/10.1038/s41598-020-63539-x

Aaron Duffy
(801) 585-1377
aaron.duffy@utah.edu