DXS's Therascreen: K-RAS mutation kit has been granted a licence by regulatory body Health Canada for use as a diagnostic for anti-EGFR therapies.
It has also been licensed for use as the companion diagnostic for Vectibix (panitumumab), Amgen's colorectal cancer therapy.
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.
According to the company, colorectal cancer is the third leading cause of cancer death in Canada, with around 22,000 diagnosed each year, causing about 9,100 deaths.
Dr Kenneth Pritzker of Mount Sinai Services in Toronto, one of the centres carrying out K-RAS testing in Canada, said: '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 personalised medicine more readily available to physicians and patients in Canada.
Following a 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 this year.
