Tempus (TEM) Wins FDA Approval for Tumor-Only XT CDx Companion Diagnostic

Tempus AI, Inc. (TEM) said on May 29, 2026 that the U.S. Food and Drug Administration approved its Tumor Only XT CDx, a next-generation sequencing test that helps match cancer patients to targeted therapies. The approval strengthens its diagnostics portfolio and opens a new commercial channel in precision oncology. The companion diagnostic identifies genetic mutations without requiring a matched normal tissue sample, accelerating testing and broadening clinical use. The company did not disclose financial terms. Shares of Tempus rose 4.2% ahead of the opening bell. The regulatory milestone deepens its foothold in the fast-growing liquid and tissue biopsy market, where rival Guardant Health also competes.