---
title: "Tempus Announces FDA Approval For Tumor Only XT CDx"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/288070238.md"
description: "Tempus AI received FDA approval for the tumor-only indication of its xT CDx platform, becoming the first lab with approvals for both tumor-only and tumor-normal profiling. This enables migration to FDA-approved assays under ADLT pricing, expected to yield a $200 ASP benefit starting in 2027. Tempus shares rose 7.39% to $55.08 in pre-market trading."
datetime: "2026-05-29T12:40:24.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/288070238.md)
  - [en](https://longbridge.com/en/news/288070238.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/288070238.md)
---

# Tempus Announces FDA Approval For Tumor Only XT CDx

(RTTNews) - Tempus AI (TEM) announced the FDA has granted approval for a tumor-only indication for its xT CDx next-generation sequencing platform. The company noted that, with the expanded label, Tempus is the first laboratory to hold FDA companion diagnostic approval for both tumor-only and tumor-normal comprehensive genomic profiling. The approval paves the way for the company to migrate its entire DNA solid tumor portfolio to FDA-approved assays priced under its current ADLT pricing.

"As we have previously highlighted, we expect an estimated $200 ASP benefit beginning in 2027 as a result of this approval," said Jim Rogers, CFO.

In pre-market trading on NasdaqGS, Tempus shares are up 7.39 percent to $55.08.

For More Such Health News, visit rttnews.com.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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