On Friday U.S. health regulators approved Qiagen NV’s gene-testing kit to identify those colorectal cancer patients most likely to benefit from Amgen Inc’s drug, Vectibix.
Not only this the Food and Drug Administration also expanded the approval of Vectibix to allow its use as an initial, treatment for colon cancer in combination with the widely used FOLFOX chemotherapy regimen.
This approval is third U.S. approval for a Qiagen companion diagnostic for use in blend with a specific drug.
Gene-testing and extension approval, could floor the way for increased use of Vectibix, which has been largely a dissatisfaction for Amgen.
It means the drug can be used earlier in the disease and would be accompanied by diagnostic to help doctors locate patients that would best respond to the medicine.
Last year 33% of total sales were from the U.S only. Amgen had $126 M sales from U.S market and in the same year the total sales was $389 M.
QIAGEN N.V. is a Netherlands-based holding company, is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue.