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Nov 10, 2010

China Medical Gets Home Country Clearance for EGFR Lung Cancer Assay

China Medical Gets Home Country Clearance for EGFR Lung Cancer Assay

Firm says test detects 28 of the most common somatic EGFR mutations.[Elnur-Fotolia.com]

  • IVD firm China Medical Technologies received Chinese regulatory approval for its first self-developed PCR-based companion diagnostic test. The EGFR assay is designed to detect whether any of the 28 most common somatic EGFR gene mutations are present in patients with non-small-cell lung cancer, to help clinicians decide on the optimum drug regimen. China Medical says approval of the EGFR assay in its home country marks the first time the Chinese regulatory authorities have cleared a PCR-based EGFR assay for use alongside lung cancer targeted drugs.

    “We plan to offer more products on our PCR platform to our top tier hospital customers served by our direct sales network,” remarks Xianodong Wu, chairman and CEO. “As of today, the company offers a comprehensive portfolio of molecular diagnostic products including FISH probes, SPR-based DNA chips, and PCR-based assays.”

    China Medical develops, manufactures, and markets IVD products using enhanced chemiluminescence immunoassay (ECLIA), fluorescent in situ hybridization (FISH), and surface plasmon resonance (SPR) technology to detect and monitor various diseases and disorders. The company’s revenues are currently generated from two general business segments: molecular diagnostic systems and immunodiagnostic systems. The molecular diagnostic system segment includes the FISH and SPR products while the immunodiagnostic system segment consists of the ECLIA portfolio.

    China Medical’s FISH and SPR technologies are operated through a wholly owned subsidiary, Beijing GP Medical Technologies, which was established in 2006. The firm say the FISH products will complement its existing ECLIA diagnostics by providing proprietary tests for the diagnosis of prenatal and postnatal disorders as well as various genetic-based cancers. China Medical’s SPR business and HPV-DNA biosensor chip were acquired in October 2008.

    The company reported revenues of RMB186.2 million ($27.5 million) for the first quarter of fiscal year 2010 (FY2010), ended June 30, 2010. Revenues were down 10.9% from the corresponding period in FY2009 but up 5.9% on 4Q FY2009.

    Molecular diagnostic system sales for 1Q FY2010 were RMB108.1 million ($15.9 million), representing a 9.8% increase on the corresponding period in FY2009, and a 7.1% increase from 4Q FY2009. The year−over−year and sequential increase was primarily due to the increase in usage of the company’s FISH probes by existing and new hospital customers served by its direct sales personnel.

    Immunodiagnostic system sales for 1Q FY2010 were RMB78.1 million ($11.5 million), representing a 29.3% decrease from the corresponding period of FY2009, but and a 4.3% increase from 4Q FY2009. The year−over−year decrease was primarily due to price reductions for ECLIA reagent kits since September 2009, the firm states.


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