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DxS Ltd's TheraScreen(R) K-RAS Companion Diagnostic Approved for Use With Amgen (AMGN)'s Vectibix(TM) in Canada
7/13/2009 1:02:10 PM
Manchester, 13th July 2009, DxS, a personalised medicine company, has had 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 personalised 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.
DxS is a personalized medicine company providing molecular diagnostics to aid doctors and drug companies in selecting therapies for patients. Working in partnership with pharmaceutical companies, DxS will support the development and sales of targeted cancer therapies by providing biomarkers and companion diagnostics.
DxS has a continually expanding portfolio of cancer mutation products. The TheraScreen® range of CE-marked clinical diagnostic kits can identify genetic tumour mutations that affect how patients respond to cancer therapies, thus enabling doctors to provide the most beneficial treatment. DxS produces two clinical diagnostic kits, K-RAS and EGFR-29.
The TheraScreen: K-RAS Mutation kit is a companion diagnostic for Vectibix™ (Amgen) and Erbitux® (Merck KGaA) for the treatment of colorectal cancer. DxS has an exclusive global distribution agreement with Roche Diagnostics for the distribution of the TheraScreen: K-RAS and TheraScreen: EGFR29 Mutation kits.
DxS’ pioneering real-time PCR technology Scorpions® is highly regarded for its proven speed and sensitivity, and is combined with ARMS (allele specific PCR) to develop each unique DxS product. This class-leading technology is also available for licence to diagnostic companies, for research, or for other varied applications.
DxS is a private, venture capital-backed company operating from the heart of Manchester’s Technology Quarter in the UK.
For further information please visit www.dxsdiagnostics.com
About colorectal cancer
This year an estimated 22,000 Canadians will be diagnosed with colorectal cancer and 9,100 will die from it.
On average, 413 Canadians will be diagnosed with colorectal cancer every week and 171 will die from the disease weekly.
One in 14 men is expected to develop colorectal cancer during his lifetime and one in 27 will die from it. One in 16 women is expected to develop colorectal cancer during her lifetime and one in 31 will die from it.
Overall, colorectal cancer is the third-leading cause of cancer death in Canada.