NEW YORK (GenomeWeb News) – Lucigen said on Tuesday that it has received ISO 13485 certification, achieving a major step required to submit a diagnostic test to the US Food and Drug Administration.

The ISO 13485 standard covers medical device and diagnostic product development and manufacturing, and certification was provided by the British Standards Institution-USA. Lucigen said that it plans to enter clinical trials in late 2014 and to release its first molecular diagnostic test in 2015.

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Jun
19
Sponsored by
Advanced Cell Diagnostics

This webinar will provide evidence for the use of RNA in situ hybridization (RNA ISH) as a replacement for immunohistochemistry (IHC) in cancer research and diagnostic applications.

Jun
21
Sponsored by
Roche

This webinar will provide a detailed look at how a genomics lab implemented next-generation sequencing (NGS) liquid biopsy assays into its in-house clinical research program.