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SFDA approves China Medical PCR KRAS assay

The China's State Food and Drug Administration (SFDA) has approved China Medical Technologies' real-time PCR-based V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) assay as a companion diagnostic test for the use of a targeted drug to treat colorectal cancer patients.

The PCR KRAS assay detects specific mutations in the KRAS gene using a real-time PCR analyzer and predicts which colorectal cancer patients are likely to respond to and benefit from the targeted drug.

The company’s other products include Fish Her-2 kit for breast cancer targeted drug and stomach cancer targeted drug, Fish BCR/ABL kit for leukemia targeted drug and Fish EGFR kit and PCR EGFR assay for non-small cell lung cancer targeted drug.