China Medical gets approval of companion diagnostic cancer test in China
China Medical Technologies (NASDAQ:CMED) said Thursday that China's State Food and Drug Administration has approved the company's PCR-based KRAS assay as a companion diagnostic test for the use of a targeted drug to treat colorectal cancer patients.
Investors cheered the news, with shares of the China-based in-vitro diagnostic company jumping over 16% to trade at $5.73 as of 2:37pm EDT Thursday.
The PCR KRAS assay is a diagnostic test 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, the company said.
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 news today expands the company's SFDA-approved product portfolio of companion diagnostic tests for targeted cancer drugs, which already includes FISH HER-2 kit for breast and stomach cancer, and other tests for leukemia, and non-small cell lung cancer.
China Medical, which uses molecular diagnostic technologies to develop its tests, said it plans to continue focusing on expanding its product portfolio.
The company generates all of its revenues in China through the sale of diagnostic consumables to hospitals which are recurring users.
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