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Data From Three Clinical Studies of bioTheranostics' Breast Cancer Molecular Test Presented at CTRC-AACR San Antonio Breast Cancer Symposium

Sunday, December 13, 2009 Research News J E 4
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SAN DIEGO, Dec. 12 bioTheranostics, a bioMerieux company that develops innovative oncology diagnostic tests to drive personalized treatment, reported today findings from three studies using the company's breast cancer molecular test. Data from the studies were presented this week at the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS).

The THEROS Breast Cancer Index® (BCI) is a combination of HOXB13:IL17BR (H/I) and Molecular Grade Index (MGI), biomarkers that improve risk stratification and treatment outcome prediction in patients with estrogen receptor (ER)-positive, lymph node-negative breast cancer. The majority of breast cancers diagnosed each year are ER-positive, lymph-node negative.

Data presented at the San Antonio meeting this week reinforce the value of the THEROS BCI as a tool that can help oncologists and patients make information-based decisions about breast cancer therapy. Specifically, the data demonstrate that the THEROS BCI assay provides reliable, quantitative and predictive information about individual patient's disease recurrence risk, as well as therapeutic response to a commonly used aromatase inhibitor.

Study Results

On Saturday, December 12, Olle Stal, PhD, of Linkoping University in Sweden, presented results from a large, randomized cohort study of 769 early-stage, post-menopausal breast cancer patients. Results of this study validated with statistical significance the risk prognosis ability of THEROS BCI in patients receiving tamoxifen monotherapy and no adjuvant treatment. In addition, the study demonstrated the value of the THEROS BCI assay as a continuous predictor for individual risk assessment. (Abstract #77)

"The predictive risk of recurrence provided by the THEROS BCI assay provides oncologists and patients with an objective and quantitative tool which helps them make informed decisions about breast cancer treatment," said Dr. Stal. "What is most important for us clinically is that the patients categorized by the BCI assay as 'low risk' had less than 4 percent chance of recurrence after 10 years." The ability to identify these low risk patients, who otherwise have pathological presentation similar to high risk patients, could significantly reduce the need for unnecessarily aggressive treatment in individual patients.

On Saturday, December 12, Laurie Habel, PhD, of Kaiser Permanente's Division of Research in Oakland, CA, presented data from a study evaluating the predictive performance of the BCI gene signatures (H/I and +MGI) among a large, independent population of 608 lymph node-negative breast cancer patients from a community hospital setting who either received tamoxifen or did not receive adjuvant therapy. Results suggest that, in this population of patients, the H/I and +MGI risk classifier is predictive of risk of breast cancer death. (Poster #4034)

Finally, on Friday, December 11, data were presented from a study in collaboration with Humphrey Gardner, MD of Novartis. These data demonstrate that the HOXB13 gene can predict response to neoadjuvant letrozole, an aromatase inhibitor, in patients with ER-positive breast cancer. Specifically, the data suggest that patients with low H/I have a three-fold greater response rate to letrozole as compared to patients with high H/I. This study reinforces the role of HOXB13 in the estrogen signaling pathway, and suggests that quantifying expression level of this gene could help physicians decide whether additional therapy is warranted in individual patients who have potentially low response rates to aromatase inhibitors. (Poster #2120)

"We are very excited about the outcome of these studies," said Richard Ding, chief executive officer of bioTheranostics. "Consistent with our previous work, this clinical evidence reinforces the clinical utility of the BCI assay. bioTheranostics is looking forward to providing this innovative diagnostic tool to clinicians to help improve risk-based and individualized treatment for breast cancer patients."

About bioTheranostics

Advancing Molecular Diagnostics in Oncology

bioTheranostics discovers, develops and commercializes molecular diagnostic tests for cancer patients. Leveraging its unique expertise in expression profiling and algorithm development, bioTheranostics provides innovative tests to the oncology community that drive personalized treatment. The company operates a CLIA-certified, CAP-accredited diagnostic service laboratory in San Diego, CA to perform its proprietary molecular diagnostic tests: the THEROS Breast Cancer Index®, that refines and improves risk stratification in patients with estrogen receptor (ER)-positive, lymph-node negative breast cancer; and the THEROS CancerTYPE ID test, a cancer classification assay that provides molecular classification of uncertain or unknown cancers to guide physicians in determination of the primary cancer site and aides in the selection of therapeutic options. For more information call 1-858-587-5870 or visit www.bioTheranostics.com.

About bioMerieux

Advancing Diagnostics to Improve Public Health

A world leader in the field of in vitro diagnostics for over 45 years, bioMerieux is present in more than 150 countries through 39 subsidiaries and a large network of distributors. In 2008, revenues reached over euro 1.111 billion with 84% of sales outside of France.

bioMerieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are used for diagnosing infectious diseases and providing high medical value results for cardiovascular emergencies and cancer screening and monitoring. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products. bioMerieux is listed on the NYSE Euronext Paris market (Code: BIM - Code ISIN: FR0010096479). Other information can be found at www.biomerieux.com.

bioTheranostics Contacts Wendy Johnson Tel: 1 858 587 5887 Wendy.Johnson@biotheranostics.com Michele Parisi Tel : 1 925 864 5028 mparisi@biocommnetwork.com

SOURCE bioTheranostics
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