PlexBio Updates ISO 13485 Certification

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PlexBio Co., Ltd. an emerging multi-national diagnostic company with an industry-leading multiplex diagnostic platform has been granted ISO 13485:2003 and EN ISO 13485:2012 Certification for its expanded scope of diagnostic products by the certifying body SGS.

PlexBio Co., Ltd. an emerging multi-national diagnostic company with an industry-leading multiplex diagnostic platform has been granted ISO 13485:2003 and EN ISO 13485:2012 Certification for its expanded scope of diagnostic products by the certifying body SGS.

PlexBio chairman and chief executive officer Dr. Dean Tsao said, “Obtaining this expanded ISO 13485 certification re-confirms the quality system processes we have put in place to develop and manufacture PlexBio products and assures our customers and their patients of the highest quality results. We are pleased that SGS has recognized our company as meeting these stringent standards.”

This certification by an independent organization also ensures that process efficiency and product safety are maintained throughout the product lifecycle. This paves the way for PlexBio to enter the market with a full line of IntelliPlexTM oncology gene mutation and gene re-arrangement tests and the accompanying, automated DigiPlexTM 100 and IntelliPlexTM 1000 instrument platforms. 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.

PlexBio’s πCodeTM MicroDiscTM 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.

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
+886 2 26275878 Ext: 103
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