FDA Documentation for Illumina PMA Extended RAS Panel by NGS

On June 29, 2017, FDA announced PMA approval of the Illumina Extended RAS panel by next generation sequencing, along with on-label use in patients with colorectal cancer receiving Amgen's Vectibix (panitumumab).  Open access news at Genomeweb, here.

FDA documentation is now coming online (here).  

• See the FDA page about the panel (here), 
• the PMA160038 technical home page (here), 
• 46-page instructions for use (here),
• 43-page summary of safety and effectiveness (here).   

For FDA documentation on the Thermo Fisher Oncomine 23-gene NGS test, approved June 22, see links here.