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# Thermo Fisher Lung Cancer Diagnostic Approved
- URL: https://www.fdaweb.com/thermo-fisher-lung-cancer-diagnostic-approved/
- Published: 2021-12-09T12:00:00.000Z
- Updated: 2026-09-14T17:25:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150742

FDA has approved a Thermo Fisher Scientific PMA for its [Oncomine Dx Target Test](https://c212.net/c/link/?t=0&l=en&o=3384336-1&h=3166516580&u=https%3A%2F%2Fwww.thermofisher.com%2Forder%2Fcatalog%2Fproduct%2FA32451%23%2FA32451&a=Oncomine+Dx+Target+Test&ref=fdaweb.com) as a companion diagnostic to help identify non-small cell lung cancer (NSCLC) patients whose tumors carry epidermal growth factor receptor Exon20-insertion mutations for potential treatment with Janssen’s Rybrevant (amivantamab-vmjw). The device uses formalin-fixed, paraffin-embedded tissue samples to identify eligible patients. “In situations where conventional testing may miss key mutations that could match patients with targeted therapies, next-generation sequencing technology is vital to make these connections and advance precision medicine,” the company says. The test simultaneously evaluates 23 genes associated with NSCLC, it says.