Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News | GenomeWeb

Beijing-based China Medical Technologies said this week that China's State Food and Drug Administration has approved its real-time PCR-based KRAS assay as a companion diagnostic test for the use of a targeted colorectal cancer drug.

KRAS mutations occur in 30 percent to 60 percent of colorectal cancers and are associated with poor response to EGFR inhibitors such as Amgen's Vectibix and Merck's Erbitux.

China Medical did not disclose the name of the drug for which its assay was approved as a companion diagnostic.

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