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DxS announces plans to expand its manufacturing capacity
Company also announces award of ISO 13485 certification


Manchester, 23 May 2008, DxS, a personalised medicine company, leaders in the provision of companion diagnostics has experienced a marked increase in the demand for its groundbreaking companion diagnostic kits. The Company has announced plans to expand its manufacturing facilities, and to significantly increase the number of staff.

In addition, the Company has also been awarded the ISO 13485:2003 quality certification for the “design, development and manufacture of molecular diagnostic products for human genetic analysis”.

DxS will take on more specialised manufacturing space at its current site in Manchester, and intends to have doubled in size over the coming months. The expansion of DxS’ manufacturing capabilities will also see an increase in staff, with further appointments expected during 2008 as these new facilities and other departments are expanded.

The increase in demand follows the recent announcement that Amgen selected the DxS TheraScreen® K-RAS assay as the preferred method of assessing a patient’s K-RAS mutation status, in order to support sales of Vectibix®, Amgen’s colorectal cancer therapy. The DxS K-RAS test has been readily adopted by Pathologists and Oncologists across Europe, due to its high sensitivity, selectivity and simple workflow.

Dr Stephen Little, CEO of DxS said: “The achievement of ISO 13485 certification underlines our commitment to provide the highest standards in our products and services, and demonstrates our ability to consistently meet customer and regulatory requirements.

“The expansion in our capacity and the planned additions to our team, reflect our commercial success and significant growth. Sales of our K-RAS companion diagnostic for Amgen’s Vectibix®, have increased radically over the last six months, necessitating an up scaling in our manufacturing facilities. We anticipate continued international growth as personalised medicine in the cancer field becomes a reality.”

ISO 13485:2003 is an international standard that defines quality management system requirements for manufacturers of medical devices. The primary objective of the standard is to facilitate harmonised quality management system requirements for regulatory purposes within the medical device sector.

-ends-

For further information, please contact:

Sue Charles, Tony Stephenson, John McIntyre
College Hill Life Sciences
+44 (0)20 7866 7864
Tony.stephenson@collegehill.com


Notes to Editors

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 .


Publisher Contact Information:

College Hill Life Sciences
+44 (0)20 7866 7864
Tony.stephenson@collegehill.com

Company profile of DxS Ltd (acquired by Qiagen)
Past press releases of DxS Ltd (acquired by Qiagen).

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