The assay, based on the Oncotype DX platform, met the primary endpoint for determining the likelihood of post-operative disease recurrence in patients with stage II colon cancer, but did not meet the endpoint for the ability to predict benefit from post-operative 5-fluorouracil/leucovorin treatment.
Citing the FDA's handling of KRAS testing for anti-EGFR monoclonal antibodies, the report asserts that in the near term complex genetic tests such as Oncotype DX should be "performed through CLIA labs, and not held up by slow regulatory processes."
A group of researchers from Israel and the US report that they have characterized chromosomal abnormalities in different colorectal cancer stages and identified alterations associated with poor outcomes.
The company said that developing the test would be its priority in 2009, putting it on a somewhat accelerated development schedule. Rosetta had originally said the test might not be available until 2010.