Press Room

December 5, 2012

bioTheranostics’ Breast Cancer Index (BCI) Molecular Test Predicts Late Distant Recurrence in Estrogen Receptor-Positive, Lymph Node-Negative Breast Cancer

The TransATAC Comparative Study Presented at San Antonio Breast Cancer Symposium Showed that BCI Outperformed Oncotype Dx and IHC4 in Prediction of Late Distant Recurrence

FOR IMMEDIATE RELEASE…Dec. 5, 2012…SAN ANTONIO…A major head-to-head study comparing bioTheranostics’ Breast Cancer Indexsm (BCI) to the Oncotype Dx Breast Cancer nAssay and IHC4 for breast cancer prognosis showed that BCI predicted late distant recurrence of estrogen receptor–positive, lymph node-negative breast cancer, while Oncotype DX and IHC4 did not. The findings were presented today at the San Antonio Breast Cancer Symposium as an oral presentation in the general session.

In the study, researchers from Massachusetts General Hospital/Harvard Medical School and London-based Queen Mary University and Royal Marsden Hospital analyzed tumor samples previously collected in the translational arm of the Arimidex, Tamoxifen, Alone or in Combination (TransATAC) study. The samples provided by The Institute of Cancer Research (ICR), London, were tested using BCI, a biomarker that improves risk stratification in patients with estrogen receptor-positive, lymph-node negative breast cancer. Comparative prognostic performance was evaluated in 665 TransATAC patients using BCI, Oncotype Dx, and IHC4; the prognostic value of each signature beyond standard clinical variables (tumor grade, size, patient age, etc.) was assessed, including prognostic evaluations for early and late distant recurrence.

Results showed that BCI was the only significant prognostic factor beyond standard clinical variables for late distant recurrence (5-10 years) (p=0.005), compared with Oncotype (p=0.5) and IHC4 (p=0.2). Similar comparative results of BCI, Oncotype DX, and IHC4 for late distant recurrence were observed for the study’s other clinical endpoints, including breast cancer death and overall survival. For early distant recurrence (0-5 years), and overall cumulative risk (0-10 years), all three tests had significant prognostic performance, and each provided prognostic information beyond standard clinical variables.

According to lead investigator Dr. Dennis C. Sgroi, director of breast pathology at Massachusetts General Hospital, the majority of breast cancer patients are estrogen receptor positive, and the risk of late distant recurrence remains a substantial concern. “A 10- to 15-year window of breast cancer management is particularly important for these patients,” Dr. Sgroi said. “This is the first large-scale clinical study to compare multi-gene signatures for their prognostic strength to quantify late distant recurrence after endocrine therapy. The results show that Breast Cancer Index is a significant prognostic factor for late distant recurrence and enables clinicians to assess the risk of recurrence in patients after five years of endocrine therapy.”

Richard Ding, CEO of bioTheranostics, said this unique head-to-head comparison provides vital new information for oncologists in the management of breast cancer patients, and demonstrates that BCI provides additional prognostic information over the US and UK standards of care. “Meta-analyses have shown that more than half of all breast cancer recurrences and deaths occur after five years for early stage breast cancer treated with adjuvant tamoxifen,” Ding said. “BCI represents a new generation of biomarkers that provide comprehensive information for disease management. It is the only test that allows the assessment of a patient’s risk of both early and late distant recurrence.”

For a copy of the study, “Comparative Performance of Breast Cancer Index (BCI) vs. Oncotype Dx and IHC4 in the Prediction of Late Recurrence in Hormonal Receptor-Positive Lymph Node- Negative Breast Cancer Patients: A TransATAC Study,” email bsullivan@sullivanpr.com.

“Dr. Schnabel has been instrumental in establishing best-in-class clinical evidence for bioTheranostics’ products,” Ding said. “Her expanded leadership role will ensure that our outstanding science will continue to be translated into clinical success.”

About Biotheranostics

bioTheranostics, Inc., is the leading solution provider for metastatic cancer management, leveraging its unique expertise in gene expression profiling to develop a growing array of molecular diagnostic tests for cancer patients. The company operates a CLIA-certified, CAPaccredited diagnostic laboratory to perform its proprietary tests: the CancerTYPE ID® molecular classification test; PRÉCIS® Precision Medicine, which includes biomarker profiles for non-small cell lung, colorectal, and other cancers; and Breast Cancer IndexSM, which quantifies risk of recurrence of estrogen receptor-positive, lymph node-negative breast cancer. bioTheranostics, a bioMérieux company, is based in San Diego. Learn more at www.biotheranostics.com.

About Royal Marsden Hospital

The Royal Marsden opened its doors in 1851 as the world’s first hospital dedicated to cancer diagnosis, treatment, research and education. Today, together with its academic partner, The Institute of Cancer Research, it is the largest and most comprehensive cancer centre in Europe, treating more than 44,000 patients every year. It is a centre of excellence with an international reputation for groundbreaking research and pioneering the very latest in cancer treatments and technologies. The Royal Marsden also provides community services in the London boroughs of Sutton and Merton and, in June 2010, along with the ICR, the Trust launched a new academic partnership with Mount Vernon Cancer Centre in Middlesex. Prince William became president of The Royal Marsden in 2007, following a long royal connection with the hospital. Learn more at www.royalmarsden.nhs.uk.

About the Cancer Institute of Cancer Research

The Institute of Cancer Research, London, is one of the world’s most influential cancer research institutes. Scientists and clinicians at the ICR are working every day to make a real impact on cancer patients’ lives. Through its unique partnership with The Royal Marsden Hospital and ‘bench-to-bedside’ approach, the ICR is able to create and deliver results in a way that other institutions cannot. Together, the two organisations are rated in the top four cancer centres globally. The ICR has an outstanding record of achievement dating back more than 100 years. It provided the first convincing evidence that DNA damage is the basic cause of cancer, laying the foundation for the now universally accepted idea that cancer is a genetic disease. Today, it leads the world at isolating cancer-related genes and discovering new, targeted drugs for personalised cancer treatment. As a college of the University of London, the ICR provides postgraduate higher education of international distinction. It has charitable status and relies on support from partner organisations, charities, and the general public. The ICR’s mission is to make the discoveries that defeat cancer. For more information, visit www.icr.ac.uk.