FDA Clears Tempus xT CDx to Run as Tumor‑Only Diagnostic

The approval removes the matched‑normal requirement so clinicians can test tumor tissue alone and opens a path for Tempus to migrate its DNA solid‑tumor tests into FDA‑cleared assays under ADLT pricing.

Overview

Tempus announced Friday that the U.S. Food and Drug Administration granted a tumor‑only indication for its xT CDx next‑generation sequencing platform, permitting the test to be run on formalin‑fixed tumor tissue without a matched blood or saliva sample.
The xT CDx is a tissue‑based NGS assay that examines 648 genes to detect single‑nucleotide and multi‑nucleotide substitutions, insertions/deletions, and microsatellite instability, and it carries companion diagnostic labeling for selecting colorectal patients for Erbitux or Vectibix.
Tempus said the expanded label makes it the first lab with FDA companion diagnostic approval for both tumor‑only and tumor‑normal comprehensive profiling and that this regulatory step enables clinical use when matched normal samples are not available.
The company plans to migrate its DNA solid‑tumor portfolio into FDA‑cleared assays priced under its Advanced Diagnostic Laboratory Test (ADLT) framework and projected an estimated $200 average selling price benefit starting in 2027, a forward‑looking estimate subject to regulatory and reimbursement risks.
Markets showed a modest reaction the same day as the approval with Tempus shares briefly rising toward $55 before reversing to trade at $50.44, a drop of about 1.66%, underscoring investor caution despite the regulatory milestone.