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China's SFDA Approves China Med Tech's Companion Dx for Colorectal Cancer

NEW YORK (GenomeWeb News) – China Medical Technologies today announced that its PCR-based KRAS assay has been approved in China as a companion diagnostic for an undisclosed drug targeting colorectal cancer.

The assay was approved by China's State Food and Drug Administration for the detection of specific mutations in the KRAS gene. According to China Med Tech, about 40 percent of colorectal cancer patients have mutations to the gene that may render them non-responsive to the targeted drug.

About 170,000 new colorectal cancer cases are diagnosed each year in China, with the incidence rate expected to increase.

The PCR KRAS assay is the most recent addition to China Med Tech's portfolio of SFDA-approved companion diagnostics, which includes its FISH HER-2 kit for breast cancer and stomach cancer drugs, the FISH BCR/ABL kit for a drug targeting leukemia, and the FISH EGFR kit and PCR EGFR assay for a drug targeting non-small cell lung cancer.