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Genomic Health Posts Positive Breast Cancer Trial Results

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Genomic Health Inc.GHDX recently announced the initial results of a multi-center trial named T rial A ssigning I ndividua L ized O ptions for Treatment (Rx), or TAILORx, which validated the clinical utility of Genomic's Oncotype DX test to risk-classify patients suffering from early stage breast cancer. Accordingly, these patients were assigned appropriate treatment options based on individual risk levels.

This prospective clinical trial, involving 10,273 women, was conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) with support from Genomic and sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). Interestingly, TAILORx is the first clinical study that evaluated a multigene expression assay like Oncotype DX wherein early stage breast cancer patients were treated according to individual risk levels.

The primary aim of this study was to establish that not all early stage breast cancer patients need to undergo chemotherapy, which has adverse side effects. Instead, hormonal therapy can lower the risk of cancer recurrence and increase survival chances, if the recurrence score is low. In this regard, Genomic's Oncotype DX Recurrence Score played a crucial role.

Evidently, it was found that 99.3% patients with an Oncotype DX Recurrence Score of 10 or less became disease free after five years of hormonal therapy alone, irrespective of age, tumor size and grade. We believe that this reflects the efficacy of Oncotype DX in enabling patients to avoid unnecessary chemotherapy treatment.

Currently, the study is doing a follow-up to determine if patients with a mid-range Recurrence Score of 11-25 can also effectively avoid chemotherapy.

We believe the aforementioned facts demonstrate that Genomic's Oncotype DX test can successfully influence the treatment decision of breast cancer patients for good. Evidently, to date, over 170,000 breast cancer patients have changed their treatment decision based on the Oncotype DX test, with a majority adopting hormonal therapy alone.

Undoubtedly, this trial result once again proved Oncotype DX as the only multigene expression assay that can successfully predict the likelihood of chemotherapy benefit in breast cancer patients and identify those who can effectively refuse the treatment. This, in turn, will boost Oncotype DX's demand in the breast cancer market.

Breast cancer has emerged as the leading cause of cancer death among women worldwide. In the U.S., breast cancer is the second most common cancer in women after skin cancer, affecting about 230,000 new patients annually. Against this backdrop, the global breast cancer therapeutics market (according to Frost & Sullivan) is expected to be worth $13.4 billion in 2019.

This recent trial result has once again successfully proved the exclusivity of Genomic's Oncotype DX test over other tests leading to ample opportunity and competitive leverage to capture a major share of this market potential.

We also believe that these positive data will elevate Genomic's position to expand reimbursement beyond Medicare and the limited coverage by private payers for its Oncotype DX test.

Currently, Genomic Health has a Zacks Rank #3 (Hold). Some better-ranked biomedical stocks are Medivation, Inc. MDVN , Gilead Sciences Inc. GILD and Nexvet Biopharma Public Limited Company NVET . All the three stocks sport a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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