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DxS Launches Cancer Mutation Kit for K-RAS in Australia

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DxS has announced the launch of its K-RAS cancer mutation detection kit in Australia. This follows the kit meeting the compliance standards of Australia’s Therapeutic Goods Administration (TGA).

DxS’ TheraScreen® K-RAS kit allows clinicians to screen patients for mutations in the K-RAS gene, which correlates with poor prognosis if patients are treated with a class of drugs called EGFR inhibitors.

The gene is mutated in approximately 35-45% of metastatic colorectal cancer as well as a variety of other cancers. By using TheraScreen, clinicians will be able to determine, from the outset, which patients will not respond to targeted cancer therapies such as Vectibix® and Erbitux®.

Commenting on the announcement, Dr. Stephen Little, CEO of DxS Ltd said: “The TheraScreen kit will serve as an invaluable tool in deciding on correct treatment regimes for cancer patients and we are pleased to be able to help Australian physicians in identifying which patients will not respond to these treatments.”

The recent data at ASCO highlight the importance of verifying K-RAS status before prescribing EGFR inhibitor compounds, and the growing significance of companion diagnostics.

In January this year, the TheraScreen diagnostic was launched to screen patients prior to use of Amgen’s EGFR inhibitor, Vectibix, given as a monotherapy for the treatment of metastatic colorectal cancer who have failed previous therapy, following EMEA market approval. The TheraScreen K-RAS Mutation test was the first clinically validated, CE-Mark certified companion diagnostic for tumor-specific mutations in colorectal cancer.

Recent publications and data from the 2008 ASCO meeting provide consistent evidence that clinical benefit from anti-EGFR treatments are only observed in patients with non-mutated K-RAS genes.

In Europe, the EMEA has restricted the use of both Vectibix and Erbitux to patients with metastatic colorectal cancer who express non-mutated K-RAS.