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news.Genomic Health, a developer and marketer of genomic-based clinical laboratory services for cancer, has initiated an independent clinical validation study for its 18-gene Oncotype DX colon cancer assay.
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Utilizing more than 1,200 patient samples from the Quasar trial, the validation study will use prospectively defined endpoints to assess the clinical utility of the Oncotype DX colon cancer assay to predict likelihood of recurrence for stage II colon cancer patients treated with surgery alone and the magnitude of treatment benefit with chemotherapy following surgery.
Results from the study are expected to be reported in the second half of 2009.
To date, Genomic Health has completed four development studies to identify and select the 18 genes for the Oncotype DX colon cancer assay.
An international, multi-center trial, Quasar examined the benefit associated with adjuvant 5FU/LV for patients with stage II colon cancer. The majority of samples for this analysis of the Oncotype DX colon cancer assay are from the UK.
Unlike the Oncotype DX breast cancer assay that captures both recurrence and treatment benefit in one recurrence score, the prognostic and predictive genes in the colon cancer assay do not overlap. As such, this colon cancer assay was designed to generate both a prognostic recurrence score and predictive treatment score.
According to the company, researchers will evaluate the association of the recurrence score with recurrence in stage II colon cancer patients treated with surgery alone. They will also evaluate the association of the treatment score with the magnitude of chemotherapy benefit in patients treated with adjuvant 5FU/LV chemotherapy.
Steven Shak, chief medical officer of Genomic Health, said: “There is a critical need for more targeted approaches in treating the tens of thousands of patients with stage II colon cancer and the initiation of this study brings us one step closer to delivering a tool that may do that.
“In developing this assay we have applied the same rigor and technology used to validate the Oncotype DX breast cancer assay, a test that has helped guide treatment decisions for more than 75,000 women with early-stage disease.”