Today Genomic Health (Redwood City, Calif.) launched its Oncotype DX colon cancer test, a 12-gene test developed for the assessment of risk of recurrence in patients with stage II colon cancer. The laboratory-developed gene expression test is available exclusively through Genomic Health's CLIA-certified laboratory.

There are approximately 30,000 stage II colon cancer in the United States. The Oncotype DX colon cancer is clinically validated to predict individual recurrence risk in these patients following surgery, according to results reported at the 2009 American Society of Clinical Oncology meeting.

Genomic Health will follow the commercialization "recipe" pioneered for the company's flagship Oncotype DX breast cancer test: launching as a test to predict cancer recurrence and adding clinical indications and clinical value.

"We'd like to take this test and do the same thing that we do with breast cancer and start to answer more questions for colon cancer patients," said Genomic Health President and CEO Kim Popovits at the J.P. Morgan Healthcare Conference on Jan. 11 in San Francisco. "In 2013, our plan is to be able to answer questions around oxaliplatin [Eloxatin] use for both stage II and stage III patients, and then we also want to take a look at targeted therapies in the colon cancer area."

Two studies that will be presented at the ASCO Gastrointestinal Cancers Symposium provide further support for the use of the Oncotype DX colon cancer test as an independent predictor of recurrence risk in stage II colon cancer patients. The new results also suggest a potential role for the test in patients with stage III disease.

The company has been savvy in steadily enhancing the clinical value of its 21-gene Oncotype DX breast cancer test. Launched in 2004 as a test to predict breast cancer recurrence, it has been expanded to include information about a patient's likelihood to benefit from chemotherapy and quantitative genetic results.

Popovits considers the expanded clinical utility of Genomic Health's $3,910 breast cancer test a significant competitive advantage. "As other assays come into the marketplace that can look at perhaps recurrence, they're not looking at chemotherapy benefit or the single-gene reporting that we have with Oncotype DX," she explained.

For more on Genomic Health, see the February 2010 issue of Diagnostic Testing and Technology Report.