Press Room

June 3, 2014

Head-to-Head Evidence Versus Oncotype Dx Further Demonstrates Superior Clinical Accuracy of bioTheranostics’ Breast Cancer Index for ER+ Patients

Study Presented at ASCO Showed BCI Identified Patients Classified as Intermediate Risk by Oncotype Dx as Having Low Risk of Recurrence, Among Other Findings

FOR IMMEDIATE RELEASE…June 3, 2014…CHICAGO…bioTheranostics, Inc., today announced additional findings from the landmark TransATAC trial, the first head-to-head study between its Breast Cancer Index (BCI) and Oncotype Dx for estrogen receptor-positive (ER+) breast cancer patients. Patients previously classified into low-, intermediate-, or high-risk groups by Oncotype DX were successfully reclassified by the BCI with statistical and clinical significance for risk of recurrence between 0–10 years following diagnosis and initial treatment. The results were presented at the 2014 American Society of Clinical Oncology (ASCO) meeting in Chicago.

In this study of 665 early stage breast cancer patients, important clinical findings included that the BCI reclassified patients classified as intermediate risk by the Oncotype Dx Recurrence Score (RS). Intermediate risk categorization by Oncotype DX is challenging in clinical practice. The results showed with statistical significance that more than 50 percent of RS Intermediate Risk patients were reclassified as low risk by BCI, and these patients had a clinically significant low risk of recurrence. These data suggest that BCI identifies a subset of patients with intermediate Oncotype DX results who may be adequately treated with endocrine therapy alone.

The BCI also reclassified patients categorized as low risk by Oncotype DX, identifying about 25 percent of patients as having a significantly higher risk of recurrence. In contrast, the Oncotype DX test did not succeed in reclassifying patients identified by the BCI with statistical significance. The poster (No. 532) was presented at ASCO June 1. Richard Ding, CEO of bioTheranostics, said, "We have previously published data showing that only the Breast Cancer Index can identify late recurrence risk accurately and predict which patients benefit from extended endocrine treatment. That data, combined with this important new 0–10 year restratification data, establish the Breast Cancer Index as a more comprehensive and accurate option for ER+ breast cancer patients and their physicians.”

“bioTheranostics has played a very important role in the remarkable progress that is being made in molecular diagnostics,” Barthelemy said. “Building on decade-long pioneering work involving the discovery, clinical development, and validation of novel biomarkers, the company is now on a trajectory to become a recognized leader in the field of next-generation cancer diagnostics. More importantly, it also is in a unique position to make a profound and positive difference in cancer care and in the quality of life of cancer patients and their families. The combination of best-in-class molecular tests addressing high unmet needs with the outstanding team built by Richard provides a solid foundation on which to take the company to the next level, and I very much look forward to the journey.”

About Breast Cancer Index

The Breast Cancer Index is a genomic signature based on the combination of biomarkers HOXB13:IL17BR and molecular grade index (MGI), which assess distinct biological pathways for breast cancer. It has the unique ability to broadly and accurately predict risk of both early (0- 5 years) and late (5-10 years) breast cancer recurrence, as well as benefit from extended endocrine therapy. The majority (about two-thirds) of breast cancer patients are estrogen receptor positive, 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 BCI 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. The company operates a CLIA-certified, CAP-accredited diagnostic laboratory to perform its proprietary tests under the bioT3 Metastatic Cancer Solution brand: CancerTYPE ID®, CancerTARGET ID, and CancerTREATMENT ID. It also offers the Breast Cancer IndexSM, which quantifies risk of recurrence of estrogen receptorpositive, lymph node-negative breast cancer. bioTheranostics, a bioMérieux company, is based in San Diego. Learn more at www.biotheranostics.com.