DakoCytomation receives FDA approval for new test kit  

The diagnostics company has received approval from the US health authority for its new diagnostic test kit, EGFR pharmDx

Diagnostics company DakoCytomation has received approval from the US health authority, FDA, for its new diagnostic test kit, EGFR pharmDx. The kit has been approved parallel to the cancer drug Erbitux from ImClone Systems. The purpose of the test kit is to determine which patients can benefit from using Erbitux for the treatment of colorectal cancer before the expensive treatment is initiated.


DakoCytomation has another test kit on the market which is used in relation to Genentech's cancer drug Herceptin. The collaboration between DakoCytomation and Genentech was the world's first example of a diagnostic kit and a drug being developed in parallel. Since its introduction in 1998 the Hercep test has been DakoCytomation's best selling product.


DakoCytomation is headquartered in Copenhagen, and has significant R&D and manufacturing activities in USA and England. It is a leading in vitro diagnostic company specialising in the identification of cancer markers in samples obtained from tissue and body fluids. DakoCytomation has operations in a number of countries and employs 1,400 people. The news is reported by BiotechDenmark online and on DakoCytomation's website.


Link > DakoCytomation 

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