PlexBio Receives CE Mark for its IntelliPlex™ Instrument System

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PlexBio Co., Ltd, an emerging multi-national diagnostic company, has received clearance to apply the CE Mark to its IntelliPlex™ 1000 πCode Processor and its PlexBio™ 100 Fluorescent Analyzer as IVD instruments. This allows the company to import and sell the instruments in the European Union and marks an important milestone for the company’s market entry strategy in Europe and elsewhere.

PlexBio Co., Ltd, an emerging multi-national diagnostic company, has received clearance to apply the CE Mark to its IntelliPlex™ 1000 πCode Processor and its PlexBio™ 100 Fluorescent Analyzer as IVD instruments. This allows the company to import and sell the instruments in the European Union and marks an important milestone for the company’s market entry strategy in Europe and elsewhere.

PlexBio Chief Operating Officer Dr. Stuart M. Palmer said, “Having now completed the CE Mark process for both our IntelliPlex™ 1000 πCode Processor and PlexBio™ 100 Fluorescent Analyzer, we can begin our European market entry activities. Our plans are to synchronize the availability of this instrument system with a full panel of single gene mutation and rearrangement assay kits useful for cancer management before the end of 2017”.

PlexBio’s πCode™ MicroDisc technology is currently the largest multiplexing platform commercially available, capable of generating over 16,000 circular image patterns. Each image pattern corresponds to an individual target which can be detected simultaneously via the advanced optical imaging and fluorescence reading capabilities of the PlexBio™ 100. The PlexBio™ 100 analyzer works in conjunction with the IntelliPlex™ 1000 processor for the hybridization of amplicon, MicroDisc washing and fluorescence labelling.

By using this higher order multiplexing platform, PlexBio is able to offer highly sensitive and specific results for both immuno and molecular diagnostic formats from very low input sample volumes - which saves time and labor. Multiple tests are currently undergoing clinical evaluation in hospital and clinical labs in the Asia Pacific region and the company expects to complete the CE Mark process for additional oncology assay kits (e.g. ROS1, RET/NTRK1, NRAS, KRAS plus) in the latter part of 2017.

About PlexBio Co., Ltd.: The company established in May 2010, designs, develops and manufactures IVD products and instrumentation from its headquarters in Taipei, Taiwan and its affiliate location in Jiangsu Province, China. PlexBio has also established an Innovative Technology Center in South San Francisco, CA, USA. The company is a listed company on the Taiwan emerging stock market.

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