Press & Media

PlexBio Receives CE Mark for PlexBio™ 100 Fluorescent Analyzer


Taipei, Taiwan – August 28, 2017 - PlexBio Co., Ltd, an emerging multi-national diagnostic company, has received CE mark for its IVD instrument, the PlexBio™ 100 Fluorescent Analyzer, and achieves an important milestone for the Company’s market strategy in Europe.

PlexBio Chairman and Chief Executive Officer Dr. Dean Tsao said, “With the second generation PlexBio™ 100 Fluorescent Analyzer receiving the CE mark, we are a step closer to introducing our full IntelliPlex™ platform. Along with the six multiplex IVD assay kits that have been CE marked, we are poised for the European market, and eventually other global regions.” PlexBio™ 100 Fluorescent Analyzer is designed to capture distinct image patterns of the patented πCode™ MicroDiscs using CCD camera. Image patterns can be recognized under bright field and then fluorescence signal intensity can be measured under dark field. This makes simultaneous detection of multiple targets possible.

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 capabilities of the PlexBio™ 100.

Multiple tests are currently undergoing clinical evaluation in hospital and clinical labs in the Asia-Pacific region. The company had previously received CE marks for six of its oncology and screening assay kits (EGFR, BRAF, KRAS, ALK, HPV, bDNA HPV) in the first half of 2017, and expects to complete the CE marking of additional oncology assay kits (ROS1, RET/NTRK1, NRAS, KRAS+) in the second half of 2017.

About PlexBio Co., Ltd.: PlexBio Co., Ltd., 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 at Taiwan emerging stock market.
http://www.plexbio.com


Contact Information:
PlexBio, Co., Ltd.
Address: 6F-1, No. 351, Yangguang St., Neihu District, Taipei City 11491, Taiwan
Tel: +886-2-2627-5878
Fax: +886-2-2627-5979
E-mail: contact@plexbio.com