Foundation Medicine received FDA approval its its NGS-based BRCA1/BRCA2 companion diagnostic (FoundationFocus CDx[BRCA] Assay (TM)), on December 19, 2016.
The tests fall under different FDA PMA classifications (Cancer Germline Detection System, for Myriad; and Next Generation Sequencing Oncology Panel, Somatic or Germline Variant Detection System, for Foundation.)
Each has detailed Safety & Effectiveness documentation and Labeling documentation online at FDA (these are 34 and 16 pages, respectively, for Myriad, and 31 and 18 pages, for Foundation).
- The FDA homepage for FoundationFocus (P160018) is online at FDA here.
- The FDA homepage for BRACAnalysis (P140020) is online at FDA here.
- This approval also has 8 links to minor supplements (such as changes in software or polymerase reagents.)
- A collated ZIP file with the five core FDA documents for each product (and the 8 minor supplements for Myriad) is in the cloud, here.
Myriad's 2014 approval order asks for a few supplements. (A) Additional testing of samples for analytical performance characteristics, with a view to variant lengths and genomic contexts; within 7 months. (B) Results from ongoing clinical trials to be submitted; with bridging study between a clinical trial assay and BRACAnalys if the former was used for enrollment. (C) Annual updates on variant classification improvements. In addition, as treatment outcome literature becomes available for a broader range of variants, please report.
Foundation's 2016 approval order also asks for a few supplements, which are similar but have some minor updates fitted to an NGS test. (A) Additional testing of samples for all variant types; including covering the range of insertions, deletions, and large rearrangements, with consideration to variant lengths and genomic contexts. (B) Additional data related to clinical samples bridged to the FoundationFocus CDx; data bridged between tests was "limited" (64/106). If tests were initially screened with a local test, a bridging study is required.
For both tests, the many pages of detailed Safety & Effectiveness documentation and Labeling documentation provide a thorough window into the FDA's requirement for validation before a PMA approval is granted.
The approval letter and safety and effectiveness labeling of the Roche Cobas EGFR liquid biopsy test are at the FDA website, here.