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AviaraDx Confirms That Combination of Two Molecular Biomarkers Improves Prediction of Disease Recurrence in Early Stage Breast Cancer Patients

-Specific biomarkers for molecular tumor grade and endocrine benefit offer

better prediction of individual patient outcome-

SAN DIEGO, May 13 /PRNewswire/ -- AviaraDx, Inc. today announced the publication of an article describing the discovery, development and validation of a new molecular biomarker, Aviara MGI(SM) (Molecular Grade Index), that improves the accuracy of breast cancer tumor grading for the prediction of distant disease recurrence. The authors also report that combining Aviara MGI with Aviara H/I(SM) (HOXB13:IL17BR), a biomarker previously shown to predict endocrine benefit, provides superior stratification of recurrence risk. The article, "A Five-Gene Molecular Grade Index and HOXB13:IL17BR Are Complementary Prognostic Factors in Early Stage Breast Cancer," appeared in the May 1, 2008 edition of Clinical Cancer Research.

The Aviara MGI and Aviara H/I ("H over I") biomarkers measure specific, independent and clinically relevant aspects of tumor biology. According to the paper published this month, the combination of these markers provides superior risk stratification as it relates to endocrine benefit and treatment outcome. After development and testing, the combination was clinically validated through retrospective analyses of 239 ER-positive, lymph-node negative patients treated at Massachusetts General Hospital, Boston, MA, and an independent cohort of 84 patients from John Radcliffe Hospital, Oxford (UK).

Aviara MGI is a new molecular assay comprising only five genes that are activated at different cell cycle stages and are involved in invasive tumor growth. This assay assists pathologists and oncologists by improving the accuracy of tumor grading.

To predict tumor aggressiveness and a potential response to chemotherapy, pathologists traditionally evaluate a breast cancer biopsy by light microscopy and assign a tumor grade. Patients with more aggressive, high grade (Grade 3) tumors have been shown to derive varying degrees of benefit from chemotherapy, while patients with less aggressive, low grade (Grade 1) tumors usually derive no benefit. However, approximately 50 percent of all early stage breast cancer patients are diagnosed with an intermediate tumor grade (Grade 2). For these patients the appropriate choice of therapy is unclear. The clinical data published this month demonstrate that Aviara MGI accurately identifies Grade 1 and 3 tumors, and successfully re-classifies intermediate tumor grade (Grade 2) into cases with Grade 1-like or Grade 3-like outcomes.

"The importance of accurate tumor grading cannot be understated," said Dennis C. Sgroi, director of breast pathology at Massachusetts General Hospital and associate professor of pathology at Harvard Medical School, a senior author of the article. "A molecular tool such as MGI that can help separate intermediate-grade tumors into two distinct prognostic groups will go a long way in stratifying risk and improving treatment selection for breast cancer patients."

Researchers combined Aviara MGI and Aviara H/I in order to assess the overall impact of both molecular tumor grade and endocrine therapy benefit on patient outcome. H/I is a well-established biomarker that has been shown to predict both recurrence risk and endocrine benefit in more than 2,000 patients in numerous clinical studies. It assesses the likelihood of a patient to benefit from endocrine therapy by measuring the functionality of the estrogen signaling pathway inside the tumor cell itself. As such, H/I goes beyond conventional estrogen and progesterone receptor (ER/PR) testing. While patients who are ER/PR positive are assumed to benefit from endocrine therapy, the therapy fails in approximately 25 percent of those patients.

"Other gene-signature assays developed for breast cancer provide an improvement over tumor grade as a measure of breast cancer aggressiveness and likely benefit from chemotherapy. These different proliferation gene signatures are essentially redundant, and they do not go beyond ER/PR in determining the likelihood of responding to endocrine therapy," said Antonius Schuh, PhD, chief executive officer of AviaraDx, Inc. "H/I and MGI together provide a more complete diagnostic picture that should help clinicians make more appropriate treatment decisions for their breast cancer patients."

"This is the first analysis linking H/I to our new, five-gene tumor grading index, MGI," said Mark Erlander, PhD, chief scientific officer for AviaraDx, Inc. "For patients whose tumors have high MGI values, it is important to measure H/I in order to determine likely benefit from endocrine therapy within the setting of a highly proliferating tumor."

The authors conclude that these two markers together should enable oncologists to identify a large subgroup of women with low risk of recurrence who may be spared from toxic chemotherapy regimens. In addition, they may also identify a significant population of patients for whom intensive chemotherapy regimens or new therapeutic agents should be considered.

"As molecular diagnostics enable the personalization of patient care, we will help patients and clinicians determine appropriate therapies and avoid both over- and under-treatment," added Schuh.

Approximately 100,000 women present with ER-positive, node-negative breast cancer in the United States every year. The data included in this month's Clinical Cancer Research publication show that the combination of Aviara MGI and Aviara H/I provides objective information to better assess both recurrence risk and potential for response to systemic therapies in these early stage breast cancer patients. The combination of these two biomarkers is now commercially available as the Aviara Breast Cancer Index(SM).

About AviaraDx, Inc.

AviaraDx discovers, develops, and commercializes new molecular diagnostic tests in oncology, enabling physicians to personalize cancer treatment through better understanding of the molecular biology underlying a patient's tumor. The company's current offerings include a molecular cancer classification assay, Aviara CancerTYPE ID(SM) capable of classifying up to 39 tumor types; Aviara H/I(SM), which predicts endocrine benefit in breast cancer; and Aviara MGI(SM), a molecular grade index to objectively measure tumor grade. Aviara H/I and Aviara MGI are available separately, or can be combined in the Aviara Breast Cancer Index(SM). Additional tests are in development. AviaraDx offers these diagnostic tests to qualified physicians or laboratories through its CLIA-certified, CAP accredited laboratory service operations. For more information, visit


Keith McCormick


SOURCE AviaraDx, Inc.
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