Data from Clinical Studies of bioTheranostics' CancerTYPE ID® and Breast Cancer Index® Molecular Oncology Test Presented at ASCO 2010 Annual Meeting*

On June 5th, scientists from bioTheranostics and the Sarah Cannon Research Institute presented interim results from a prospective trial examining treatment of carcinoma of unknown primary (CUP) site directed by CancerTYPE ID. While prior studies of CUP patients with empirical chemotherapy (standard of therapy) have shown median survival of 7 months on the low end and 11 months on the high end, interim findings from the UNKPRI20 study suggest that selecting treatment based on results from the CancerTYPE ID assay leads to median survival of 12.9 months.

“To the best of our knowledge, this is the first prospective study designed to evaluate the efficacy of treatment in CUP patients directed by a molecular classifier,” said Mark Erlander, Ph.D, chief scientific officer, bioTheranostics. “We and our collaborators are very encouraged by the results, which suggest that molecular tumor profiling is an effective strategy for patients with CUP.”

bioTheranostics also presented data from a study completed in collaboration with the University of Pittsburgh Medical Center. The study was designed to evaluate Breast Cancer Index (BCI), a continuous risk index to predict recurrence and survival of ER (+) and node (-) breast cancer patients. Using multivariate analysis, researchers concluded that BCI is a significant predictor of distant recurrence and overall survival - more accurate than Adjuvant! Online as well as traditional clinical and pathologic features.

“This study, in combination with the results from a Swedish cohort study that we shared at the San Antonio Breast Cancer Symposium last year, further validates the clinical value of Breast Cancer Index,” said Dr. Erlander.

Finally, bioTheranostics announced during ASCO the commercial launch and availability of the company’s B-RAF mutation test. B-RAF mutations are found in colorectal, melanoma, ovarian, and thyroid cancers. B-RAF mutation status can be a valuable tool to help guide the use of anti-EGFR therapies.

“The positive outcomes presented this week from the latest CancerTYPE ID and Breast Cancer Index clinical studies are very exciting and reinforce the clinical validity and utility of these molecular tests,” said Richard Ding, chief executive officer of bioTheranostics. “The launch of B-RAF is another example of how our company provides high medical-value oncology testing services to our customers.”

* ASCO Abstract Numbers 10540 and 10582

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: Breast Cancer Index®, which refines and improves 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 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.

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

bioMérieux Contact
Koren Wolman-Tardy
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media@eu.biomerieux.com