China Medical Technologies' EGFR PCR Assay for lung cancer targeted drugs receives Chinese SFDA approval

Nov 10 2010

China Medical Technologies, Inc. (the "Company") (Nasdaq: CMED), a leading China-based advanced in-vitro diagnostic ("IVD") company, today announced that it has received approval for its real-time PCR-based Epidermal Growth Factor Receptor ("EGFR") Assay (the "EGFR PCR Assay") for the use of lung cancer targeted drugs from the State Food and Drug Administration of China (the "SFDA").

The EGFR PCR Assay is used for the detection of the 28 most common somatic mutations in the EGFR gene of patients with non-small cell lung cancer ("NSCLC") and provides a qualitative assessment of mutation status to determine the use of lung cancer targeted drugs for patients.

With its own internal research and development efforts, the Company has successfully developed its first PCR-based assay related to companion diagnostic tests for personalized medicines for cancer patients. The Company's EGFR PCR Assay is the first PCR-based EGFR assay for the use of lung cancer targeted drugs approved by the SFDA.

"We plan to offer more products on our PCR platform to our top tier hospital customers served by our direct sales network," commented Mr. Xiaodong Wu, Chairman and Chief Executive Officer of the Company. "As of today, the Company offers a comprehensive portfolio of molecular diagnostic products including FISH probes, SPR-based DNA chips and PCR-based assays. We believe we can further expand these three technology platforms by offering more products on each platform. In addition, we will leverage our direct sales network, which covers over 400 top tier hospitals in China, to promote our new products which have important clinical benefits and good market potential."

Lung cancer is one of the most common cancers in the world and it is the leading cause of cancer death in China. It is estimated that more than 500,000 new lung cancer cases were diagnosed each year in China and the incidence rate of lung cancer is expected to continue to increase. According to publications in medical journals, EGFR abnormalities have been found in approximately 85% of NSCLC patients responsive to Iressa and Tarceva, two commonly used drugs for the treatment of patients with NSCLC.