Tuesday, October 18, 2016

Brief Blog: How did FDA Approve the Roche EGFR Liquid Biopsy Test? (Links)

In June 2016, the FDA approved the Roche cobas EGFR test for the liquid biopsy format.
Take home lesson: The validation and technology review process was very elaborate.  And it's all public record.

 Online, see the FDA's numerous validation and reference documents:
  • FDA PMA HomePage for PMA150047, here.
  • FDA Approval order, here.
  • FDASafety & Effectiveness review, 53p, PMA150047, June 1, 2016, here.
  • FDA/Roche Product Labeling, 71p, here.
For some personal insights from staff both at Roche and at the FDA, see discussion at the FDA Liquid Biopsy conference, July 2016 (here for PPTs and transcripts).

Other links include:
  • FDA's press release, here.
  • FDA home page for test, here and here.
  • Roche 10 page brochure about test, here.
  • Roche product home page, here.
  • Roche product specific web site, here.

Some key FDA documents provided as links above are in one easy to handle Zip file in the cloud, here.


Original FDA EGFR cobas-in-paraffin approval as PMA120019, here.  
FFPE update to include T790M resistance mutation, here.