BioView Gets FDA OK for Duet System for ALK Rearrangements | GenomeWeb

NEW YORK (GenomeWeb) – BioView announced on Wednesday that the US Food and Drug Administration has cleared for marketing the firm's Duet System to detect rearrangements involving the ALK gene in non-small cell lung cancer samples.

Specifically, the system has been cleared for the qualitative detection of ALK rearrangements via fluorescence in situ hybridization in formalin-fixed paraffin-embedded NSCLC tissue specimens that are probed with the Abbott Vysis ALK Break Apart FISH Probe Kit.

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