bioTheranostics’ Breast Cancer IndexSM Molecular Test Identifies Risk for Early and Late Breast Cancer Recurrence, Lancet Oncology Study Finds

Women at low risk for late recurrence can avoid unnecessary treatment; those at high risk can consider further therapy

FOR IMMEDIATE RELEASE…Sept. 12, 2013…SAN DIEGO…, A study published online in The Lancet Oncology found that in a comparison of three methods of predicting the risk of recurrence of estrogen-receptor (ER)-positive breast cancer, only the Breast Cancer IndexSM (BCI) from bioTheranostics predicts risk for both early (0-5 years) and late (5-10 years) recurrence. The study provides important new information to guide patient treatment decisions at diagnosis and after several years of therapy.

According to the researchers, this is the first published study to compare the ability of biomarkers to predict early and late disease recurrence in a large trial of women with ER-positive breast cancer. The study compared the predictive ability of the new BCI molecular test with two existing breast cancer assays—a 21-gene recurrence score (Oncotype DX) and an immunohistochemical (IHC4) test.

Dr. Dennis C. Sgroi, director of breast pathology at Massachusetts General Hospital and lead investigator on the study, said BCI identified 61 percent of patients in this study as having a low risk of late recurrence, indicating they may not need continued therapy. The test also identified 39 percent of patients as having a high risk of late recurrence, indicating they should be considered for extended therapy.

“This information generated by BCI could be extremely valuable and have fundamental relevance to breast cancer oncologists and patients, especially those who are at five years post-diagnosis,” Dr. Sgroi said. “This is highly relevant to clinical management as it has been demonstrated in previous studies that late disease recurrence is a hallmark of ER-positive breast cancer, with more than half of recurrences occurring after five years of adjuvant therapy.”

Richard Ding, president and CEO of bioTheranostics, said the study is a defining moment in the evolution of breast cancer management and firmly establishes the BCI as a vital molecular tool. “Earlier-generation biomarker tests predict only risk of early recurrence, despite the fact that half of women with ER-positive breast cancer relapse after five years of treatment,” Ding said. “The BCI addresses this problem for the first time, opening a new chapter of personalized care for breast cancer patients. In combination with a previous study demonstrating BCI’s ability to predict which patients are most likely to benefit from extended therapy, BCI allows physicians and breast cancer patients to make better-informed decisions about treatment.”

The prospective comparison study was conducted by researchers at Massachusetts General Hospital, Queen Mary University and Royal Marsden Hospital in London, the University of Otago in New Zealand, and bioTheranostics. They looked at tumor samples from 665 post-menopausal women with ER-positive breast cancer enrolled in the Arimidex, Tamoxifen, Alone or in Combination (ATAC) clinical trial. The samples had previously been tested by the 21-gene recurrence score and IHC4. BCI analysis was conducted, and researchers assessed the ability of the BCI to predict 10-year risk of recurrence, comparing it to the 21-gene recurrence scores and IHC4. They also tested the ability of the assays specifically to predict early and late distant recurrence beyond standard clinicopathological variables.

Findings show that all assays had significant ability to predict early distant recurrence, but only BCI predicted late distant recurrence. For late recurrence, only 3.5 percent of women in the low-risk group based on BCI results experience recurrence of their breast cancer, compared with 15.4 percent in the high-risk group. To access the study, click here.

About bioTheranostics

bioTheranostics is the leading solution provider for metastatic cancer management, leveraging its unique expertise in expression profiling to develop a growing array of molecular diagnostic tests for cancer patients. The company operates a CLIA-certified, CAP-accredited 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 and colorectal cancers, 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. For more information, visit www.biotheranostics.com.