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A new milestone:ACCB got The Practicing License of Medical Institution

Source:Date:2015-06-08Views:1101

    Since its founding in 2004, ACCB is focus on the innovation of tumor molecular diagnostic approach and translational medical research in cancer diagnosis and therapies. As one of the earliest high-tech scientific enterprise in China, ACCB contains an 3000 m2 modernized in vitro diagnostic reagent factory,a standardized R&D clean laboratory of 10 K class , and has passed the  ISO13485 Quality Management System Certification. ACCB has established cooperation with the global-leading biotech. companies including Life Technologies, Abbott and GENEWIZ, and its products cover major molecular detecting platform including real-time fluorescent quantitation PCR (RT-PCR), fluorescent in situ hybridization (FISH), first  and second generation sequencing (Sanger and NGS) . Molecular detection Kits of EGFR, KRAS, BRAF and PIK3CA for tumor individualized therapies have got the License of Registration and the certification from CFDA and CE, respectively.   
 
    ACCB’s Medical Laboratory got the Practicing License of Medical Institution on May 4, 2014, and becomes the first enterprise in China containing the credentials to manufacture and services in the molecular pathological field. Due to operation procedure and strict quality control systems of the international standard (CAP, GLP, and ISO15189), ACCB’s Medical Laboratory is becoming the first-class molecular pathological detection and technical training center in tumor individualized treatment.

 

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