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China Medical Technologies Gets China OK for EGFR Assay

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – China Medical Technologies today said that it has received regulatory approval from Chinese authorities to market its real-time PCR-based Epidermal Growth Factor Receptor assay as an aid in making treatment decisions for lung cancer patients.

The Beijing-based firm said that its assay can detect the 28 most common somatic mutations in the EGFR gene of patients with non-small cell lung cancer and provides a qualitative assessment of mutation status. It is the firm's first PCR-based assay for companion diagnostic applications and is the first PCR-based EGFR assay approved by the State Food and Drug Administration of China.

The company estimated that there are more than 500,000 new lung cancer cases diagnosed in China each year. It further noted that around 85 percent of NSCLC patients are responsive to Iressa (gefitinib) and Tarceva (erlotinib), two commonly used drugs for the treatment of patients with NSCLC.

"We plan to offer more products on our PCR platform to our top tier hospital customers served by our direct sales network," Xiaodong Wu, chairman and CEO of China Medical Technologies said in a statement. He noted that the firm's molecular diagnostics portfolio includes FISH probes, SPR-based DNA chips, and PCR-based assays.