DxS has experienced a marked increase in the demand for its 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 specialized 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 personalized 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 harmonized quality management system requirements for regulatory purposes within the medical device sector.