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Data from Clinical Studies of bioTheranostics’ CancerTYPE ID® and Breast Cancer Index(SM) Molecular Diagnostic Tests Presented at ASCO 2011 Annual Meeting

June 7, 2011

SAN DIEGO, June 7, 2011 /PRNewswire/ — bioTheranostics, Inc., a bioMerieux company that develops innovative oncology diagnostic tests to drive personalized treatment, reported today findings from clinical studies utilizing the company’s CancerTYPE ID®, and Breast Cancer Index(SM). Data from the studies were presented this week at the American Society of Clinical Oncology (ASCO) 2011 Annual Meeting in Chicago.

On June 6, scientists from bioTheranostics and the Institut Gustave-Roussy (France) presented results from a study evaluating the utility of the Breast Cancer Index(SM) (BCI) for predicting pathologic complete response (pCR) in breast cancer patients treated with neoadjuvant chemotherapy. In the study, patients with a high BCI score had a more favorable response to standard chemotherapies such as anthracycline and taxane (P=0.02).

“Patients determined as high-risk by BCI had a 10-fold greater probability of pCR with the chemotherapy regimen when compared to the low risk patients,” said Mark Erlander, Ph.D., chief scientific officer, bioTheranostics. “These results suggest that BCI is predictive of chemotherapy response.”

bioTheranostics also presented diagnostic utility data for CancerTYPE ID® from a study of 754 metastatic cancer cases. The results showed that pre-CancerTYPE ID® pathological workup involved a mean of seven immunohistochemistry (IHC) stains to identify the cancer site of origin. Increasing the number of IHC stains beyond seven lengthened the diagnostic process without improving the accuracy of the final result.

“Quickly and accurately diagnosing the site of origin is critical in the care of metastatic cancer patients,” said Richard Ding, chief executive officer, bioTheranostics. “This study illustrated that the current diagnostic process is not standardized and often time- consuming.” In the study, CancerTYPE ID required only five days of lab processing to predict a single primary site in more than 90 percent of the cases, and provided a more objective and informative diagnosis to physicians.

Finally, in collaboration with a group of international clinicians, bioTheranostics presented data from a study evaluating the utility of a novel P95 assay. The study assessed the assay’s ability to identify the truncated form of the Her2 gene in Her2-positive breast cancer patients as a means to predict trastuzumab response.

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. 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(SM), which is a prognostic test that provides quantitative risk assessment of distant recurrence in patients diagnosed with estrogen receptor positive and lymph node negative breast cancer; and the CancerTYPE ID® test, which uses the differential expression of 92 genes to aid in the determination of 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 2010, revenues reached EUR1.357 billion with 87% 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

bioTheranostics Contacts

Tim Schofield
Tel: + 1 858 587 5890
tim.schofield@biotheranostics.com

Michele Parisi
Tel: + 1 925 864 5028
mparisi@biocommnetwork.com

bioMerieux Contact

Koren Wolman-Tardy
Tel: + 011 33 6 13 94 51 14
media@eu.biomerieux.com

SOURCE bioTheranostics, Inc.


Source: newswire



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