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PlexBio Receives CE Mark for Fluorescence Analyzer

NEW YORK (360Dx) – PlexBio said today that it has received CE marking for a second-generation fluorescence analyzer, the PlexBio 100, which captures "distinct image patterns" recognized by bright-field microscopy and measures fluorescence-signal intensity by dark-field microscopy.

Its πCode MicroDisc multiplexing platform complements the analyzer, the firm said. The multiplexing platform can generate more than 16,000 circular image patterns, each of which corresponds to an individual target, and the analyzer can then use optical imaging and fluorescence to simultaneously detect these targets. 

Receiving CE marking puts the firm a step closer to introducing its IntelliPlex instrument platform, Dean Tsao, chairman and CEO of PlexBio, said in a statement. He said that with this new regulatory clearance for the analyzer and CE marking already received for six multiplex IVD kits, the firm is poised for European market entry and eventual expansion to other global regions.

In the first half of 2017, the firm received CE marking for six oncology and screening kits for EGFR, BRAF, KRAS, and ALK mutations, as well as HPV and bDNA HPV.

Taipei, Taiwan-based PlexBio noted that several of its tests are undergoing clinical evaluation in hospital and clinical labs in the Asia-Pacific region. In the second half of this year, it expects to receive CE marking of additional oncology kits for ROS1, RET/NTRK1, NRAS, and KRAS+ mutations.