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AviaraDx, Inc. Release: HOXB13/IL17BR Ratio (H/I(TM) Ratio) Predicts Clinical Benefit for Prolonged Endocrine Therapy in ER-Positive Breast Cancer Patients

5/3/2007 10:06:05 AM

CARLSBAD, Calif., May 3 /PRNewswire/ -- AviaraDx, Inc., a leader in molecular cancer diagnostics, announced today the publication of an independent two-site 357 patient study in the April 23, 2007 issue of Breast Cancer Research Treatment entitled: "Exploring the two-gene ratio in breast cancer-independent roles of HOXB13 and IL17BR in the prediction of clinical outcome" by Piiha-Lotta Jerevall & Olle Stal, Division of Oncology, Department of Biomedicine and Surgery, Linkoping University, Linkoping, Sweden and Sara Brommesson & Marten Ferno, Department of Oncology, Clinical Sciences, University Hospital, Lund, Sweden and their respective co-authors.

The investigators examined the expression of HOXB13 and the H/I(TM) ratio in biopsy material of a previously conducted prospective trial, in which postmenopausal early stage breast cancer patients were randomized to either two or five years of endocrine therapy. The investigators show ER-positive patients with a high H/I(TM) ratio did not benefit from extended endocrine therapy. Conversely, in patients with a low H/I(TM) ratio a significantly longer period of disease-free survival was observed under extended endocrine therapy. The results were statistically significant in multivariate analysis, after adjusting for known prognostic and predictive factors, such as tumor size, nodal status, and PR.

The investigators conclude the H/I(TM) ratio and HOXB13 alone can predict clinical benefit of endocrine therapy. Specifically, high HOXB13 gene expression and/or a high H/I(TM) ratio within the tumor indicates reduced likelihood to respond. Furthermore the authors concluded the H/I(TM) ratio could be used to identify patients resistant to endocrine therapy and therefore may need different adjuvant treatment.

"This controlled study is the fourth validation of the H/I(TM) ratio and more importantly the second publication from independent clinical researchers validating the clinical utility of the H/I(TM) ratio. We are pleased to see the growing evidence supporting the clinical use of the H/I(TM) ratio as both a prognostic and predictive tool to aid in treatment decisions, said Antonius Schuh, Chief Executive Officer of AviaraDx.

About Breast Cancer

There are over 274,000 new breast cancer cases annually of which approximately 165,000 cases are classified as estrogen receptor positive (ER+). As a population, ER+ patients have a good 5-year survival prognosis when treated with surgery and hormonal therapy. Five years of tamoxifen treatment of ER-positive patients reduces the annual breast cancer death by about one third, but still almost 25% of the women participating in trials of adjuvant endocrine therapy with tamoxifen fail to respond and relapse in 10 years. These patients represent a group where alternative therapy could be beneficial.

About AviaraDx, Inc.

AviaraDx, Inc. is focused on discovering, developing and commercializing novel molecular oncology tests which aid in personalizing treatments. The company is targeting the oncology market with three first-in-class molecular cancer tests and technologies: molecular classification and identification of metastatic cancer known as CancerTYPE ID(TM), a breast cancer test known as HOXB13/IL17BR ratio or H/I(TM) ratio, and under development, Drug Response Profiling assays. AviaraDx received its CLIA laboratory certification in April 2007 and will be offering the H/I(TM) test through their clinical laboratory based in Carlsbad, California. Please visit the AviaraDx website at for more information.

Contact: Sherri Heffner (760) 579-0513

AviaraDx, Inc.

CONTACT: Sherri Heffner of AviaraDx, Inc., +1-760-579-0513

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