> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Approves Rozlytrek Companion Diagnostic
- URL: https://www.fdaweb.com/fda-approves-rozlytrek-companion-diagnostic/
- Published: 2023-01-05T12:00:00.000Z
- Updated: 2026-09-14T18:10:56.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5153478

FDA has approved Foundation Medicine’s FoundationOne Liquid CDx as a companion diagnostic to identify patients with ROS1-positive non-small cell lung cancer, or patients with NTRK fusion-positive solid tumors, who do not have a tissue sample available and may be appropriate for treatment with Rozlytrek (entrectinib). A company [statement](https://www.businesswire.com/news/home/20230104005548/en/?ref=fdaweb.com) says Rozlytrek is a targeted therapy developed by Genentech. It says FoundationOne is the only blood-based companion diagnostic approved for Rozlytrek.