Genomic Health, Inc. (GHDX) announced that positive results were published in the journal, The Lancet Oncology, from a study of the company’s growth engine, Oncotype DX, in postmenopausal women suffering from node-positive, estrogen receptor-positive breast cancer. The study was conducted by the Southwest Oncology Group (SWOG) and funded by the National Cancer Institute and Genomic Health. The findings were presented at the American Association for Cancer Research San Antonio Breast Cancer Symposium.
The study evaluated whether the Oncotype DX test can predict, which women would stand to gain from chemotherapy. The study not only evaluated the efficacy of 21 genes from a tumor but also produced a score that predicts chemotherapy benefit. The analysis suggested that women having a low score on the Oncotype DX test did not appear to benefit, while those with higher scores stood to benefit.
The trial studied 367 tumor samples from node-positive, estrogen receptor-positive patients suffering from breast cancer who took part in the SWOG/breast cancer intergroup of North America trial. The study evaluated the chemotherapy regimen cyclophosphamide, Adriamycin and 5-fluorouracil (CAF) followed by tamoxifen versus only tamoxifen, to determine the prognostic and predictive effects of the Oncotype DX recurrence score.
It was found that the recurrence score in the tamoxifen-alone arm was highly prognostic and demonstrated predictive ability in patients treated with chemotherapy followed by tamoxifen. The study did not find any chemotherapy benefit in the low recurrence score group. However, significant disease-free survival improvement was found for the high recurrence score group.
Genomic Health, founded in 2000 and headquartered in Redwood City, California, is an oncology-based biotech company focused on the development and commercialization of genome-based clinical tests to diagnose cancers that allow physicians and patients make individualized treatment decisions.
Oncotype DX- the company’s lifeline – was launched in January 2004 and is used for early stage breast cancer patients to predict the likelihood of cancer recurrence, the likelihood of patient survival within 10 years of diagnosis and the likelihood of chemotherapy benefit. All tumor samples are sent to the company’s laboratory in Redwood City for analysis. The laboratory has the capacity to process approximately up to 15,000 tests per quarter. Upon generation and delivery of a Recurrence Score report to the physician, the company generally bills third-party payers for Oncotype DX.
Even though sales of the assay remain robust and the company remains optimistic about its prospects, we are highly concerned about the company’s reliance on Oncotype DX for growth and its weak pipeline. We believe that Genomic needs to expand its product portfolio in order to sustain growth.
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