Positive Data from Genomic Health

Genomic Health (GHDX - Analyst Report), an oncology based biotech company, presented initial data for a prostate cancer study. About 295 genes associated with clinical recurrence following radical prostatectomy were identified.

Based on encouraging data, the company will be going ahead with full clinical development of the study. Along with Cleveland Clinic, the research partner, the company plans to present complete data at ASCO in February 2011.

Successful development of the test will be beneficial for the patients as it will guide the physicians in determining the course of treatment. The test will assist the doctor decide from the various options of active surveillance and immediate prostatectomy, radiation therapy, or the need for adjuvant therapy after initial treatment. Prostate cancer, the most common type of non-skin cancer found in American men, is the second leading cause of cancer deaths in men.

Currently, Genomic Health derives almost all sales from the Oncotype DX breast cancer test. Although the company has launched the Oncotype DX colon cancer test, it is yet to contribute significantly to the company’s top line. However, the company is conducting various studies to diversify its revenue base.

One of the other important pipeline studies is related to the utility of the Oncotype DX test in patients with ductal carcinoma in situ (DCIS). The company has initiated sample processing for the DCIS clinical validation trial utilizing the Oncotype DX breast cancer test and anticipates reporting results in the first half of 2011. More than 40,000 such cases are diagnosed each year in the US. Despite low risk of recurrence or progression, many patients are treated with mastectomy, radiation and hormonal therapy.

The company seeks to identify those DCIS patients who can be managed with surgery alone based on individual gene expression. Moreover, the Journal of Clinical Oncology published results which suggest that the HER2 gene expression measured by Oncotype DX has a high degree of agreement with commonly used FISH testing.

Genomic Health will also be presenting results from seven studies at an upcoming breast cancer conference next week. The studies are related to the company’s flagship product, Oncotype DX breast cancer test to predict the likelihood of cancer recurrence, patient survival within 10 years of diagnosis and chemotherapy benefit.

We currently have an Outperform rating on the stock.