Brief Blog: Comparing the FDA BRCA Approvals for Myriad & Foundation Medicine

Myriad Genetics received FA approval for its BRCA1/BRCA2 companion diagnostic (BRACAnalysis CDx (TM)), on December 19, 2014.

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.
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• 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.)

The FMI approval order is linked directly to clinical use with Rubrca, and the Myriad approval is linked directly to clinical use with Lynparza.

• 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.

Update: An April 27, 2017 article in Genomeweb discusses that FMI's test is less-validated for longer insertions and deletions or large rearrangements, and that Clovis Oncology is getting approval for on-label use of the Myriad test with its PARP inhibitor Rubraca (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.

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The approval letter and safety and effectiveness labeling of the Roche Cobas EGFR liquid biopsy test are at the FDA website, here.