Clinical Utility Of Two Novel Genes That Can Identify Patients At Higher Risk For Early Breast Cancer Recurrence

Main Category: Breast Cancer
Also Included In: Cancer / Oncology;  Genetics
Article Date: 30 Apr 2006 - 0:00 PDT

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AviaraDx, Inc., formerly known as Arcturus Bioscience, Inc., a leader in molecular cancer profiling, announced today that a study, conducted in collaboration with Mayo Clinic, demonstrated the clinical utility of two novel genes that can identify patients at higher risk for early breast cancer recurrence and has been published in the April 2006 issue of Clinical Cancer Research.

Researchers at Mayo Clinic tested the level of expression of the HOXB13 and IL17BR genes from paraffin-embedded tumor tissue derived from postmenopausal women with early stage, estrogen positive breast cancer who were enrolled in an earlier prospective tamoxifen study conducted by the North Central Cancer Treatment Group. They demonstrated that the 2-gene expression ratio was an independent marker of early breast cancer relapse and overall survival in lymph node negative breast cancer patients, but not lymph node positive tumors.

"The study with Mayo Clinic is the first of a series of clinical studies conducted by AviaraDx, its clinical collaborators and independent research groups, which we expect to be published in peer reviewed scientific journals this year," said Antonius Schuh, Chief Executive Officer of AviaraDx. "We are excited about the rapidly growing body of evidence supporting the clinical utility of HOXB13 and IL17 in the prediction of breast cancer recurrence and are expecting our diagnostic licensing partners to launch a testing service based on both biomarkers in 2006."

AviaraDx discovered both biomarkers in a collaborative study with Harvard Medical School and Mass. General Hospital which was published in the June 2004 issue of Cancer Cell. As a result of this study, these two biomarkers serve as the foundation of the AviaraDx Breast Cancer Recurrence (BCR) Technology. Breast cancer is diagnosed in over 200,000 women each year and claims the lives of over 40,000 in the United States alone. More than 2/3 breast cancers are hormone positive, and most of these are early stage (lymph node negative).

About AviaraDx, Inc.

AviaraDx, Inc., formerly Arcturus Bioscience, Inc., is a leader in describing disease at the molecular level to enable molecular medicine and the development of proprietary technologies for diagnostic applications in oncology.

These technologies include the Molecular Cancer Identification (MCID) technology which is based upon a set of clinically validated molecular signatures relating to 90% of the most common cancers, and the Breast Cancer Recurrence (BCR) Technology, which is based upon a proprietary biomarker index for the prognosis of breast cancer recurrence risk and metastatic potential.

Commercialization of the MCID Technology commenced with its licensing partners Quest Diagnostics, and Laboratory Corporation of America and Agendia BV for their Cancer of Unknown Primary (CUP) diagnostic service. Quest Diagnostics has also licensed the BCR Technology for the development of a diagnostic service. AviaraDx technologies and intellectual properties position the Company to address the multi-billion dollar market opportunities associated with the development and commercialization for additional cancer diagnostics and inventions to cost-effectively improve patient prognosis and response prediction in cancer therapy.

AviaraDx has recently relocated its headquarters from Mountain View, California to Carlsbad, California. Please visit the AviaraDx website at http://www.aviaradx.com for more information.

Forward Looking Statements

AviaraDx, Inc. cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. For example, statements about the Company's expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are all forward-looking statements. These forward-looking statements are based upon AviaraDx's current expectations. The Company's actual results and the timing of events may differ materially from those set forth in this release as a result of certain risks and uncertainties, including, without limitation: uncertainty regarding market acceptance of the Company's technologies; rapid pace of technological change in the identification and validation of proprietary biomarkers for the prognosis of increased breast cancer recurrence risk; uncertainty of product development and the associated risks related to clinical trials; the risk that the U.S. Food & Drug Administration will not approve the Company's products or technologies, or that such approval will be delayed or require substantial additional testing and information, which could result in increased costs and uncertainty; the Company's ability to continue to conduct clinical trials; uncertainty relating to third party reimbursement; the ability of the Company or its commercial partners to convince health care professionals and third party payers of the medical and economic benefits of the Company's products and technologies; the risk of loss of collaborative arrangements with third parties; the difficulty in managing growth and successfully managing resources; and other risks. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise.

AviaraDx, Inc.
http://www.aviaradx.com