Manchester, UK, 1 July 2008 - DxS, a personalised medicine company and leaders in the provision of companion diagnostics, has today 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 tumour-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.
Vectibix is a trademark of Amgen Inc.
Erbitux is a trademark of ImClone Systems Inc.
DxS is a personalised medicine company providing products, technology and services to the healthcare industry to enable the delivery of safe and effective medicines. The Company has also established itself as a leader in the provision of companion diagnostics to the personalised cancer medicine market.
DxS has a range of products including cancer mutation assays and kits, molecular diagnostic technologies and genetic analysis services. Its TheraScreen® range of CE-marked kits can identify genetic tumour mutations affecting how patients respond to cancer therapies, enabling doctors and drug companies to provide the treatment most likely to benefit patients. DxS produce two clinical diagnostic kits, K-RAS, and EGFR-29. The K-RAS assay has been chosen as the companion diagnostic for Amgen’s colorectal cancer therapy Vectibix®.
DxS’ real-time PCR technology, Scorpions® utilises its speed and sensitivity and underpins the products and services. This class-leading technology is also available for licence to diagnostic companies, for research, applied and other applications.
DxS is a private, venture capital backed company operating from Manchester’s Technology Quarter within the UK.
For further information please visit www.dxsdiagnostics.com .
For further information, please contact:
Sue Charles, Tony Stephenson, John McIntyre
College Hill Life Sciences
+44 (0)20 7866 7864
Tony.stephenson@collegehill.com
