Breast Cancer Chemotherapy Sensitivity
More than 2/3rd of invasive breast cancer is treated with chemotherapy. Taxane-containing chemotherapy is considered the most advanced and effective for of chemotherapy in breast cancer. Nuvera has conducted IRB-approved, prospective neo-adjuvant (pre-operative) therapy trials led by MD Anderson as a model to develop biomarkers of taxane-chemotherapy response. Nuvera has also utilized a novel response measure called residual cancer burden (RCB) (Symmans et al., J Clin Oncol 2007) to identify complete responders. The Company is currently completing validation of its gene-based assay to predict responders to taxane-chemotherapy.
Breast Cancer Endocrine Therapy Sensitivity
All patients with estrogen receptor (ER)-positive breast tumors (~70% of invasive breast cancer) receive adjuvant endocrine therapy as either tamoxifen or an aromatase inhibitor (AI). Beyond ER status, no other information exists to adequately identify response to endocrine therapy. Nuvera’s endocrine sensitivity test was developed by measuring expression of genes most strongly associated with the estrogen receptor. The test has been evaluated in multi-center studies worldwide in patients who received adjuvant tamoxifen for 5 years as their only systemic therapy. Test performance has shown significant separation of survival among the group of patients identified as responders versus the non-responders.