Founded in July 2011, with individualized diagnosis and treatment of cardiovascular, tumor and other major diseases as the strategic direction, Wuhan ZYZ Medical Science and Technology Co., Ltd. is a high-tech enterprise specializing in the development, production and sales of personalized medical diagostic products. The company has established various technical platforms, including ARMS fluorescence quantitative PCR, multiple fluorescence quantitative PCR, nucleic acid mass spectrometry, fluorescence in situ hybridization(FISH) and circulating tumor cell detection etc. Meanwhile, the self-developed products includes molecular diagnostic products to guide personalized medicine for cardiovascular and cerebrovascular diseases, companion diagnostic products to guide tumor diagnosis and treatment, FISH products and circulating tumor cell (CTC) detection products, all these provide clinical diagnosis basis for precision medicine.The company has successfully developed over 160 genetic diagnostic products and multiple in vitro diagnostic (IVD)devices since 2014, among which 13 molecular diagnostic kits have obtained medical device registration certificates in Class III to enter the Chinese market from National Medical Products Administration (NMPA).
With a R&D center of 2,000㎡and industrialization workshop of 3,200㎡ with GMP standard , the Company obtained the "Medical Device Manufacturing Enterprise Licence" issued by Hubei Food and Drug Administration, and passed the ISO13485:2016 international standard quality system certification. The following innovative products has passed the European Union (CE) certification: Circulating Tumor Cell Detection Device (CTC-BIOPSY ®）, Human EGFR Gene Mutation Test Kit, Human SLCO1B1 and ApoE Gene Test Kit etc.
