To date in the United States, no tests have been approved by the Food and Drug Administration for testing KRAS in tumor samples. The test used in the panitumumab study, called the DxS KRAS, has a CE marking (a mandatory conformity marking in the European market). Amgen is currently collaborating with the maker of the test, DxS Ltd., to guide this test through the regulatory process of the FDA, Dr. Amado said.
Dr. Tabernero disclosed that he is a consultant to and receives honoraria from several pharmaceutical companies, including Merck KGaA, which sponsored his study. Dr. Amado is an employee of Amgen and owns stock in the company.
'Clinicians should definitely start checking for KRAS status in their patients with advanced colorectal cancer.' DR. TABERNERO