Study Shows Use of bioTheranostics’ Breast Cancer Index Molecular Test Lowers Medical Costs

In In The News by Barbara Jacoby

Thumbnail for 8562Study Shows Use of bioTheranostics’ Breast Cancer IndexSM Molecular Test Substantially Lowers Medical Costs for ER+ Breast Cancer Patients Compared with Standard Management

Cost Savings Provided by Optimizing Initial Chemotherapy & Extended Endocrine Therapy After Five Years

According to a health economics study published online in The American Journal of Managed Care, bioTheranostics’ Breast Cancer IndexSM molecular test is associated with lower medical costs when used either at diagnosis or at five years post-diagnosis in estrogen receptor-positive (ER+) breast cancer patients.

The study—the first to look at the economic impact of the Breast Cancer Index—evaluated the cost utility of the test from a U.S. third-party payor perspective, assessing the economic impact of implementing the assay in a population of ER+ patients at diagnosis and five years post-diagnosis compared with standard practice. The Breast Cancer Index is a second-generation gene expression test that has been shown in clinical studies to predict risk of both early (0-5 years) and late (5-10 years) breast cancer recurrence, as well as likelihood of benefit from extended endocrine therapy.

Results from the health economic model show that the Breast Cancer Index is cost saving compared with standard management. Cost savings were driven by optimal use of adjuvant chemotherapy at the time of diagnosis and of extended endocrine therapy in patients who were recurrence-free five years after diagnosis, as well as increased patient compliance with treatment. Use of the Breast Cancer Index resulted in average savings of $3,803 per patient at diagnosis, after accounting for the cost of the test. In patients tested five years post-diagnosis, use of the test resulted in savings of $1,803 per patient.

Catherine Schnabel, PhD, Senior Vice President, Research & Development for bioTheranostics, said this study is significant, especially given the major safety, tolerability, and costs associated with endocrine therapy. “There is a critical need to identify which patients are likely to derive benefit from extended endocrine therapy, as consideration of adjuvant treatment beyond five years is increasing,” Schnabel said. “This study shows that using the Breast Cancer Index to stratify patients based on their risk of recurrence and likelihood of treatment benefit allows for optimization of extended endocrine therapy for patients most likely to benefit, while allowing other patients to avoid unnecessary treatment and drug-related side effects, and associated costs.”

Haythem Ali, M.D., medical oncologist at the Henry Ford Heath System, who was an author on the study, said, “Extended adjuvant hormonal therapy is beneficial for some patients, which is clear from multiple studies. Using tools such as the Breast Cancer Index to distinguish those who benefit from those who don’t maximizes benefit and minimizes harm. Being cost-effective is an encouraging added bonus.”

The economic analysis was funded by bioTheranostics and completed by Health Advances, a leading healthcare consulting firm. Gary Gustavsen, Vice President for Personalized Medicine at Health Advances and lead author of the study, said, “In today’s cost-constrained environment, this study provides important clarity on the Breast Cancer Index’s economic impact. Given its utility in both newly diagnosed and five-year post-diagnosis patients, the test fills an unmet need in helping physicians determine the long-term management of these patients. Understanding the test’s economic savings will be important as third-party payors seek to establish medical policy surrounding the test.”

About Breast Cancer Index

The Breast Cancer Index is a genomic signature based on the combination of biomarkers H/I (HOXB13:IL17BR) and molecular grade index (MGI), which assess distinct biological pathways for breast cancer. It has the unique ability to predict risk of both early and late recurrence, as well as likelihood of benefit from extended endocrine therapy. Two-thirds of breast cancer patients are ER+, and the risk of late recurrence is a substantial concern, with about 50 percent of recurrences occurring after five years. Clinical research data on the Breast Cancer Index have been published in numerous peer-reviewed publications such as Lancet Oncology, Journal of the National Cancer Institute, and Clinical Cancer Research, and include more than 2,200 patients.

About bioTheranostics

bioTheranostics, Inc., is the leading solution provider for early stage breast cancer and a broad range of metastatic cancers, leveraging its unique expertise in gene expression profiling to develop a growing array of molecular diagnostic tests for cancer. The company operates a CLIA-certified, CAP-accredited diagnostic laboratory to perform its proprietary tests: the Breast Cancer IndexSM and the bioT3 Metastatic Cancer Solution suite of tests, which includes CancerTYPE ID® and CancerTREATMENT NGS+. bioTheranostics, a bioMérieux company, is based in San Diego. Learn more at