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Lung Cancer Panel From PlexBio Receives CE Mark

NEW YORK (GenomeWeb) – Taiwanese diagnostics firm PlexBio said today that it received CE marking for its IntelliPlex Lung Cancer Panel, an in vitro molecular diagnostic assay for the qualitative identification of 36 DNA mutations.

The assay can identify mutations in the KRAS, NRAS, PIK3CA, BRAF, and EGFR genes, as well as 19 gene rearrangements of the ALK, ROS1, RET, NTRK1, and MET genes from formalin-fixed, paraffin-embedded tumor tissue from lung cancer patients, PlexBio said. It added that the assay leverages its SelectAmp and πCode technologies.

The πCode technology is a circular disc that can generate more than 16,000 image patterns for multiplexing. According to the company's website, SelectAmp is a mutation-enriching PCR amplification method that increases mutation detection sensitivities.

"We believe the benchmark established by our IntelliPlex Lung Cancer Panel with FFPE samples will provide the necessary foundation for the application to liquid biopsy as the next step," PlexBio Chairman and CEO Dean Tsao said in a statement.