DxS’ TheraScreen® K-RAS Companion Diagnostic Approved for Use with Amgen’s Vectibix™ in Canada
News Jul 16, 2009
DxS has announced that its TheraScreen: K-RAS Mutation Kit granted a licence by the regulatory body Health Canada for use as a diagnostic for anti-EGFR therapies and as the companion diagnostic for Amgen’s colorectal cancer therapy, Vectibix™ (panitumumab).
The availability of the TheraScreen: K-RAS Mutation Kit will allow colorectal cancer patients in Canada to be screened using the DxS diagnostic to assess their suitability for treatment with Vectibix™.
Studies have shown that patients with the non-mutated K-RAS gene may respond to treatment with Vectibix™. Approximately 60 per cent of metastatic colorectal cancer patients have a non-mutated K-RAS gene. Colorectal cancer is the third-leading cause of cancer death in Canada, with around 22,000 diagnosed each year, causing 9,100 deaths1.
Dr. Kenneth Pritzker, Mount Sinai Services, Toronto, one of the leading centres carrying out K-RAS testing in Canada said "This is extremely good news that we now have a registered method for K-RAS testing. The DxS K-RAS test is simple to use, highly sensitive and is the companion diagnostic test of choice for assessing a patient's response to Vectibix™."
The approval of the TheraScreen: K-RAS Mutation Kit is a step forward in making personalized medicine more readily available to physicians and patients in Canada.
The future of cancer treatment will be guided by the use of technological advances such as these, which enable physicians to better manage a patient’s disease or predisposition towards a disease. Now physicians can choose a treatment approach that is likely to work best in the context of a patient’s genetic and environmental profile.
Following the global distribution agreement signed in 2008, Roche Diagnostics will be distributing and supporting sales of the TheraScreen: K-RAS Mutation Kit in Canada beginning in August of this year.