Back on August 21, 2024, Illumina announced it had received approval for a 517-gene panel, including TMB, and two PMA companion diagnostic claims. The PMA claims are NTRK ("solid tumors") for Vitrakvi, and RET fusions (NSCLC) for Retevmo.
After the usual delay of a few weeks, FDA has posted the core documents supprting the approval. These include the "approval order," (letter 5pp), the Summary of Safety and Effectiveness (175pp), and the official final Labeling (152pp includes instructions for use IFU). The letter has a remark about 'agreed upon modifications' of reporting.
The extensive documentation (e.g. the 175 S&E review) might be scary for anyone intending to do LDT PMA tests with their own lab's local test under the FDA LDT regulations recently finalized. On the other hand, PMA applications are not due til 2027 and FDA has planned to downclassify "most PMA tests" over a period of years.
Find the info on the home page for PMA P23011 here:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230011
The FDA has separate serial summary effectiveness statements on pages 113-114 for NTRK, RET, and "for tumor profiling used by health care professionals."
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| Approval Order | Approval Order |
|---|---|
| Summary | Summary of Safety and Effectiveness |
| Labeling | Labeling |
