BEIJING, Oct. 13, 2011 /PRNewswire-Asia-FirstCall/ — 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.
About China Medical Technologies, Inc.China Medical
Technologies, Inc. is a leading China-based advanced IVD company
using molecular diagnostic technologies including Fluorescent in
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