Genomic Health's Oncotype DX Redefines Breast Cancer Therapy - Analyst Blog

Genomic Health, Inc. GHDX reported positive results from an initial validation study of Oncotype DX in patients suffering from a pre-invasive form of breast cancer, also known as ductal carcinoma in situ (DCIS). This is the second largest, independent clinical study of Oncotype DX.

The Ontario DCIS Study Group in Canada conducted this clinical study which met its primary endpoint by substantiating that the Oncotype DX DCIS Score can predict the risk of local recurrence. Local recurrence indicates either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast.

DCIS is a stage zero breast cancer that affects 1 out of every 5 women in the U.S. The study revealed that approximately 80% of women diagnosed with DCIS currently receive unnecessary aggressive therapy, while others in need of it often miss the chance of undergoing the advance treatment. This often causes cancer to proliferate, which could have otherwise been avoided with proper treatment.

However, the above-mentioned study showed that Oncotype DX can predict individual risk of recurrence and thereby help in taking suitable treatment decisions. This not only leads to timely treatment decisions but also reduces healthcare costs.

The aforementioned study results represent the largest genomic study in DCIS to date.  These results reaffirm the inferences of the previously-released validation study performed by the ECOG-ACRIN Cancer Research Group.  

This is the first time the Oncotype DX DCIS Score has succeeded in predicting the risk of local recurrence in a group of patients treated with radiation therapy in clinical practice.

The study involved more than 1,200 patients diagnosed with DCIS between 1994 and 2003. Researchers from Genomic Health collaborated with the Ontario DCIS Study Group to examine the tumor samples collected from these patients. The patient group constituted both patients treated with surgery alone and those treated with surgery plus radiation.

Genomic Health and the Ontario DCIS Study Group plans to submit the results from this study at the 2014 San Antonio Breast Cancer Symposium in December.  Recently, a clinical decision impact study presented at the American Society of Clinical Oncology (ASCO) revealed that the Oncotype DX DCIS Score results have changed treatment recommendations for 1 out of 3 patients with

DCIS, highlighting the need for optimizing treatment of DCIS. The Oncotype DX DCIS Score looks at 12 genes within a tumor sample to reveal the aggressiveness of the disease.

Genomic Health currently has a Zacks Rank #3 (Hold). Some better-ranked stocks worth considering in the biomedical industry include ANI Pharmaceuticals, Inc. ANIP, Gilead Sciences Inc. GILD and Illumina Inc. ILMN. All these stocks carry a Zacks Rank #1 (Strong Buy).
 

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