Biotheranostics, Inc. announces new data from studies for both of its proprietary molecular diagnostic tests, CancerTYPE ID and Breast Cancer Index (BCI) to be presented on Saturday, June 2nd and Monday, June 4th at the annual meeting of the American Society of Clinical Oncology in Chicago.
In a longstanding diagnostic and treatment dilemma, 30% of patients with bone metastases do not receive a definitive diagnosis of tumor type because of poor tumor differentiation and degradation of tumor markers during specimen processing. In a study of over 1200 cases of patients with unknown or uncertain cancer, CancerTYPE ID demonstrated a solid analytical success rate in bone biopsies, with more than 40% of cases receiving a molecular tumor type diagnosis for which an FDA-approved indication for immune checkpoint inhibitors is available.
“The results of this analysis demonstrate that Cancer TYPE ID provides a foundation for a very promising diagnostic workflow for patients presenting with bone-predominant metastatic disease,” said Kanwal P. S. Raghav, MBBS, MD, study author and Assistant Professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX. “Whereas in the past, a large proportion of these patients would not have received a definitive diagnosis, now, with integration of the tissue-sparing 92-gene assay, the molecular diagnosis of tumor type allows for more appropriate tumor-specific therapy planning, downstream biomarker testing as well as consideration of immunotherapy enriched clinical trials for select patients.”
Evaluation of long-term risk of breast cancer recurrence is another clinical situation requiring individualization of therapy. Breast Cancer Index (BCI) identified nearly 30% of estrogen receptor positive breast cancer patients with 98% long-term breast cancer–specific survival (BCSS) out to 20 years, indicating that these patients may be effectively treated with a five-year course of anti-estrogen therapy. For comparison, a recent analysis of a genomic biomarker in the same Stockholm randomized controlled trial examining indolent biology revealed that only 15% of patients were classified as ‘ultralow risk,’ with a corresponding 20-year BCSS of 97%.
In other studies, Breast Cancer Index significantly predicted pathological complete response to neoadjuvant chemotherapy (NACT) in estrogen receptor positive (ER+) breast cancer patients, beyond traditional clinicopathologic factors and was correlated with overall survival. The potential clinical utility of BCI for predicting which patients are likely to respond to, and which patients may be spared and might consider alternative treatment strategies, such as neoadjuvant endocrine therapy, has been met with enthusiasm and warrants additional study. Additionally, an analysis was completed to further characterize BCI and BCIN+, the algorithm optimized for lymph node positive disease (N1, 0-3 lymph nodes) with the addition of tumor size and tumor grade and available since June 2016, for the prediction of late distant recurrence in post-menopausal women with hormone receptor positive breast cancer treated with tamoxifen or anastrozole. Catherine Schnabel, PhD, Chief Scientific Officer, Biotheranostics said:
We continue to be excited with the ability of Breast Cancer Index to stratify hormone receptor positive patients into clinically meaningful subsets for optimal treatment. Aside from validated data to aid in decision-making for addition of chemotherapy and/or extended endocrine therapy, the biomarker has emerging activity in the neoadjuvant setting."