bioTheranostics' Breast Cancer Index(SM) Predicts Risk for Late Recurrence in Early Stage ER-Positive Breast Cancer Patients

SAN DIEGO, Dec. 10, 2010 /PRNewswire/ -- bioTheranostics, a bioMerieux company that develops innovative oncology diagnostic tests to support targeted disease management, announced today new findings from a clinical study evaluating the company's Breast Cancer Index (BCI) molecular oncology test. Data from the study were presented at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS).

The company also announced that the Breast Cancer Index is now available to provide quantitative assessment of the risk of distant disease recurrence.  The BCI risk assessment  is based on data from a recently completed large, randomized, retrospective trial.(1)

"The results presented in San Antonio today become part of a substantial and growing body of data supporting the clinical value of the Breast Cancer Index," said Richard Ding, chief executive officer of bioTheranostics. "We are pleased to make this valuable test available to oncologists and pathologists in an enhanced format with clinical data specific for late breast cancer recurrence."

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

Data presented today are from the MA.17 study, a previously conducted, randomized prospective trial.  This study evaluated the role of adjuvant endocrine therapy with letrozole in reducing the risk of recurrence and improving disease-free survival among women with breast cancer who completed five years of tamoxifen therapy. As part of the study, Massachusetts General Hospital researchers Paul Goss, MD, PhD and Dennis Sgroi, MD retrospectively evaluated the ability of the Breast Cancer Index to distinguish those patients at risk of late recurrence and those who would respond to extended therapy with letrozole.  

Data from the study demonstrate that BCI is a prognostic biomarker for late recurrence  among ER-positive breast cancer patients. The data also confirm that HOXB13, part of the Breast Cancer Index, predicted patient benefit from letrozole among ER-positive breast cancer patients.

"For breast cancer patients and the medical professionals who treat them, this is a significant finding," said Dennis Sgroi, MD, Massachusetts General Hospital. "It is our understanding that this is the first time a biomarker has been validated exclusively in the 'late recurrence' setting.  It will be a valuable tool to help identify those patients whose disease will most likely recur, as well as those who will benefit from extended therapy."

"In combination with data from the Stockholm cohort presented at last year's SABCS, the data presented today reinforce BCI's unique prognostic value and application for long-term risk prognosis in the breast cancer setting," said Mark Erlander, PhD, chief scientific officer of bioTheranostics.

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 to support targeted disease management. The company operates a CLIA-certified, CAP-accredited diagnostic service laboratory in San Diego, CA to perform its proprietary molecular diagnostic tests: Breast Cancer Index, which provides risk stratification in patients with estrogen receptor (ER)-positive, lymph-node negative breast cancer; and the CancerTYPE ID® test, a cancer classification assay that provides molecular classification of cancers with indeterminate, uncertain, or differential diagnoses to aid in the determination of the tumor site of origin. 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 2009, revenues reached euro 1.223 billion with 85% 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 cancer screening and monitoring and cardiovascular emergencies. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.

bioMerieux is listed on the NYSE Euronext Paris market (Symbol: BIM – ISIN: FR0010096479).

Other information can be found at www.biomerieux.com.

(1) Stal, O., et. al., Validation of prognostic utility of HOXB13:IL17BR and molecular grade index in early stage breast cancer [abstract #77]. 32nd Annual CTRC-AACR San Antonio Breast Cancer Symposium. December 2009.

SOURCE bioTheranostics