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New Studies Demonstrate Clinical Utility and Validity of CancerType ID® Molecular Classifier
Date:3/22/2012

VANCOUVER, Canada, March 21, 2012  – bioTheranostics, Inc. announced today findings from three key studies. Results, presented at the United States and Canadian Academy of Pathology (USCAP) annual meeting, showed that CancerTYPE ID® had strong clinical utility and demonstrated a high level of accuracy for tumor classification and sub-classification. Tumor classification and sub-classification are important criteria in treatment selection with the advent of site- and subtype-specific therapies.

CancerTYPE ID is a standardized, objective, 92-gene molecular cancer classifier that classifies a broad range of distinct tumors by matching the gene expression pattern of a patient's tumor to a database of gene expression information from known tumor types and subtypes.

In a large retrospective analysis (USCAP 2012 Abstract # 429), researchers found that current immunohistochemistry (IHC) practices are non-standardized in protocol, interpretation and in time to completion, further underscoring a significant need for additional analytical approaches to aid in resolving indeterminate and differential diagnoses. Results indicate that more than seven IHC stains were associated with longer-than-average time to diagnosis but were not associated with increased diagnostic resolution.

The researchers further noted that an assay database with broad tumor coverage would be an important consideration for clinicians, as CancerTYPE ID predicted 23 main tumor types and 42 subtypes in the 754 cases reviewed.

In a second study, a multi-institutional analysis and the most comprehensive validation of a molecular classifier to date, CancerTYPE ID demonstrated excellent performance for classification of a diverse set of tumors (USCAP 2012 Abstract # 1888) that was consistent with previous validation results. The study reviewed 790 cases in collaboration with the Mayo Clinic, the University of California, Los Angeles (UCLA) and Massachusetts General Hospital (MGH).

The same researchers also evaluated the use of CancerTYPE ID to predict the site of origin for primary and metastatic tumors with neuroendocrine differentiation (USCAP 2012 Abstract # 604). Findings from this analysis indicated CancerTYPE ID may address an unmet medical need as a molecular correlate for sub-typing neuroendocrine tumors. The ability to subtype neuroendocrine tumors, among the most difficult to determine, has important implications for grading, staging and disease management.

"The 92-gene classifier demonstrated excellent accuracy for subtyping tumors with neuroendocrine differentiation," said Mark Erlander, PhD, Chief Scientific Officer of bioTheranostics. "While these results were part of a larger parent study designed to characterize performance of the classifier in a broad range of tumor histologies, these findings show promise for use of the 92-gene assay in classifying neuroendocrine tumors of uncertain primary site."

"In these recent studies, CancerTYPE ID's accuracy was also noted in both metastatic as well as poorly differentiated primary tumors, and its diagnostic value was maintained even in situations where there was limited tissue," said Richard Ding, Chief Executive Officer of bioTheranostics. "We believe this is an important step in discovering where a molecular classifier, such as CancerTYPE ID, fits in the diagnostic picture as an accurate, objective and time-saving adjunctive pathology asset. We appreciate the independent and growing support from pathologists in utilizing CancerTYPE ID as a standardized diagnostic aid in their workup of metastatic cancers."

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: breastcancerindex, 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 CancerTYPE ID, 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 more than 45 years, bioMerieux is present in more than 150 countries through 39 subsidiaries and a large network of distributors. In 2011, revenues reached euro 1.427 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

FOR INFORMATION:

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

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


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SOURCE bioTheranostics, Inc.
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