SFDA approves China Medical Technologies' colorectal cancer assay

Oct 13 2011

China Medical Technologies, Inc. (the "Company") (Nasdaq: CMED), a leading China-based advanced in-vitro diagnostic ("IVD") company, today announced that China's State Food and Drug Administration (the "SFDA") has approved the Company's real-time PCR-based V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog ("KRAS") assay (the "PCR KRAS Assay") as a companion diagnostic test for the use of a targeted drug for the treatment of colorectal cancer patients.

The PCR KRAS Assay is a diagnostic assay used for the detection of specific mutations in the KRAS gene using a real-time PCR analyzer. It predicts which colorectal cancer patients are likely to respond to and benefit from the targeted drug. About 60% of colorectal cancer patients have a non-mutated KRAS gene, while the remaining colorectal cancer patients with mutations may not be responsive to the targeted drug.

According to the Chinese Ministry of Health, colorectal cancer is one of the most common digestive tract cancers. About 170,000 new colorectal cancer cases were diagnosed each year in China, and the incidence rate is expected to increase.

The PCR KRAS Assay expands the Company's SFDA approved product portfolio of companion diagnostic tests for targeted cancer drugs. The product portfolio currently includes FISH HER-2 kit for breast cancer targeted drug and stomach cancer targeted drug, FISH BCR/ABL kit for leukemia targeted drug, FISH EGFR kit and PCR EGFR assay for non-small cell lung cancer targeted drug as well as the newly approved PCR KRAS assay for colorectal cancer targeted drug. The Company plans to continue focusing on expanding its product portfolio.