Oncomine Dx Express Test - FDA's 85-page Summary

In terms of transparency of its review process and standards, for genomic tests, FDA publishes a detailed "Summary of Safety and Effectiveness" within a few months of approving a new test kit.

FDA approved the Oncomine Dx Express Test on July 2, 2025.  The 85-page summary of the validation is online at FDA under PMA, P240040.  Home page here.

https://www.accessdata.fda.gov/cdrh_docs/pdf24/P240040B.pdf

The test has authorization for tumor mutation profiling in cancer patients with solid malignant neoplasms, as well as a PMA CDx authorization for Zegfrovy (sunvozertinib) with EGFR Exon 20 mutations.  The kit runs on the Ion Torrent™ Genexus Dx Integrated Sequencer.

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Also available online at FDA is the summary of validation for Illumina Trusight Oncology Comprehensive.  Find under PMA P230011, from August 21, 2024. On NextSeq 550dx.