Press & Media

TFDA Licenses for IntelliPlex™ KRAS and KRAS+


Taipei, Taiwan – August 6, 2018 - PlexBio Co., Ltd, an emerging multi-national diagnostic company, has passed GMP inspection and received export licenses from the Taiwan FDA for its CE Marked IntelliPlex™ KRAS and IntelliPlex™ KRAS Mutation Plus Kits. The additional CE-IVD oncology assay kits (ROS1, RET/NTRK1, NRAS, EGFR, BRAF, ALK) are expected to receive the TFDA GMP certificate and export licenses in the next few months. Combining with the established placement of PlexBio’s CE Marked IntelliPlex™ 1000 πCode Processor and PlexBio™ 100 Fluorescent Analyzer available in Europe, these reagent certificates and license officially launch off the sale of CE-IVD assay products, transitioning from RUO oriented sale to occupying the IVD Company Diagnostic market, bring company revenue from IVD reagents segment. These milestones also grant the company access to further expand its accessible markets from Europe to Middle East, Asia Pacific and Central/South America regions of the world.

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 target amplicon or antigen, MicroDisc washing and fluorescence labelling. By using this higher order multiplexing platform, PlexBio is able to offer highly sensitive and specific results for both molecular diagnostic and immunoassay formats from very low input sample volumes - which saves time and labor. The novel development would help the governments to reduce the healthcare expenditures.

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