PlexBio Receives Market Approval for Second Generation DigiPlex™ System

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Leading multiplex diagnostic platform has received certification of market approval for the DigiPlex™ analyzer from the Food and Drug Administration of the Taiwan Ministry of Health and Wellness.

PlexBio Co., Ltd. an emerging multi-national diagnostic company with an industry-leading multiplex diagnostic platform has received certification of market approval for the DigiPlex™ analyzer from the Food and Drug Administration of the Taiwan Ministry of Health and Wellness. The certification means that the DigiPlex is approved for sale on the Taiwan market as a Class I device.

PlexBio Chief Technology Officer Dr. Chin-Shiou Huang said, “With this certification, we can now expand our market presence and collaborations here in Taiwan. The system upgrades have been designed to enhance performance and customer convenience. And with our extensive menu of research use and IVD reagent kits, this will have a real impact in the Taiwan clinical market and beyond.”

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 DigiPlex 100 instrument. 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 APAC region and shortly will undergo market evaluation in Europe. The company expects the oncology marker assays and IntelliPlex™ and DigiPlex instrument systems to achieve the CE-Mark in the first half 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 at Taiwan emerging stock market. http://www.plexbio.com

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Cheryl Chang
PlexBio
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