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Nov 9, 2009

Chinese Authorities Clear China Medical’s Leukemia Diagnostic Kit

  • China Medical Technologies received Chinese regulatory approval for its leukemia BCR/ABL fusion gene detection FISH probe. The molecular diagnostic test kit is used to detect the Philadelphia translocation genetic defect associated with chronic myeloid leukemia, acute lymphoblastic leukemia, and acute myeloid leukemia.

    China Medical develops, manufactures, and markets advanced IVD products using FISH, enhanced chemiluminescence, and surface plasmon resonance (SPR) technologies. In October Chinese regulatory authorities approved the company’s SPR-based analysis system, for which an HPV-DNA biosensor chip is available.

    The company already offers a range of FISH probes for diseases including breast cancer, bladder cancer, and cervical cancer. Additional FISH probes are also in clinical development or under regulatory review in China.

     



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