bioTheranostics Announces Commercial Availability of Expanded Tumor-Type Database for CancerTYPE ID® and the Launch of KRAS Testing

CancerTYPE ID® predicts cancer origin in patients whose primary cancer was initially “unknown or uncertain” using conventional diagnostics. Knowing the site where the cancer originated impacts physicians’ therapeutic decisions, and the results of the CancerTYPE ID® assay can help physicians select optimal therapies earlier in the diagnostic process.

The larger CancerTYPE ID® database allows for an increase of reportable tumor types from 39 to 54, while maintaining overall accuracy. Specificity across all tumor types remains high at >99 percent. This new database enhances the ability of the CancerTYPE ID® assay to discriminate between clinically relevant metastatic tumors occurring within the GI tract, head and neck, lung (squamous, non-squamous adenocarcinoma, and mesothelioma), and intestine, while incorporating coverage of certain tumor types that frequently present diagnostic challenges such as cholangiocarcinoma, ovarian-mucinous adenocarcinoma, and small intestinal carcinoma.

In tissue samples for which CancerTYPE ID® returns a positive result for colorectal cancer, the availability of KRAS, a companion diagnostic test for anti-EGFR therapy, enables medical professionals to obtain additional valuable information and make individualized treatment decisions. KRAS will also be offered as a stand-alone test. “Since the CancerTYPE ID® molecular classifier became available two years ago, we’ve carefully tracked both our customer feedback and our own clinical laboratory experience to identify important, emerging diagnostic opportunities,” said Richard Ding, bioTheranostics’ chief executive officer. “The addition of these new tumor types and the KRAS assay are significant steps in addressing the evolving needs of our customers and making the CancerTYPE ID® assay the leading molecular solution for clinicians and patients.”

About the bioTheranostics CancerTYPE ID® Assay

The CancerTYPE ID® assay is a 92-gene molecular cancer classifier. It is particularly useful for oncologists and pathologists managing metastatic cancer patients whose primary tumor is either poorly differentiated or undifferentiated following assessment using conventional diagnostic tests. The results of the CancerTYPE ID® assay can guide physicians in selecting optimal therapies for these individuals and potentially improve treatment outcomes. CancerTYPE ID® can be run on a variety of tissue specimens including FFPE blocks from surgical resections, excisional biopsies, fine needle aspirates (FNA) and biopsy, core needle biopsies, cell blocks (pleural effusions, ascites, and FNAs), and bone marrow. A minimum of 300-500 viable tumor cells is required for testing.

About bioTheranostics

bioTheranostics discovers, develops and commercializes molecular diagnostic tests for cancer patients. Leveraging its unique expertise in genomic profiling and proprietary algorithms, bioTheranostics provides innovative tests to the oncology community that help drive personalized treatment. The company operates a CLIA-certified, CAP-accredited, diagnostic service laboratory in San Diego, California, to perform its proprietary molecular diagnostic tests: CancerTYPE ID®, a molecular cancer classifier particularly helpful for patients diagnosed with metastatic cancer whose tumor origin is either uncertain or unknown through conventional diagnostic testing; and the Breast Cancer Index®, which refines and improves risk stratification in patients with estrogen receptor (ER)-positive, lymph-node negative breast cancer. More information is available at www.biotheranostics.com.

About bioMérieux

Advancing Diagnostics to Improve Public Health

A world leader in the field of in vitro diagnostics for over 45 years, bioMérieux is present in more than 150 countries through 39 subsidiaries and a large network of distributors. In 2009, revenues reached €1,223 million with 85% of sales outside of France.

bioMérieux 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. bioMérieux is listed on the NYSE Euronext Paris market (Symbol: BIM – ISIN: FR0010096479). Other information can be found at www.biomerieux.com.

Contacts

For bioTheranostics:

Wendy Johnson
Tel: 1 858 587 5887
Wendy.Johnson@biotheranostics.com

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

For bioMérieux:

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