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Tempus AI Launches FDA-Approved xT CDx for Comprehensive Solid Tumor Profiling

NextEdge Admin

15 Jan 2025

2 min 11 sec

Tempus AI, a leader in AI-driven precision medicine, has announced the nationwide launch of its FDA-approved NGS-based in vitro diagnostic test, xT CDx. This 648-gene next-generation sequencing (NGS) test provides comprehensive solid tumor profiling, including microsatellite instability (MSI) status and companion diagnostic claims for colorectal cancer.

xT CDx utilizes a normal-matched approach, sequencing both tumor and normal samples in parallel to enhance the accuracy of identifying cancer-driving somatic variants. All tumor + normal match test orders previously run on the xT assay will now be processed as xT CDx without any workflow changes.

"We are excited to introduce xT CDx, which combines our trusted performance with FDA approval," said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. "Our commitment to delivering high-quality, comprehensive assays ensures clinicians have actionable insights to improve patient outcomes."

Clinicians can supplement molecular insights by adding xR RNA sequencing, xF/xF+ liquid biopsy, immunohistochemistry tests (HER2, PD-L1), and algorithmic analyses (HRD, IPS), offering a streamlined approach to patient care.

xT CDx is intended for detecting substitutions, insertions, deletions, and MSI status in FFPE tumor tissue and matched normal samples from cancer patients. It serves as a companion diagnostic (CDx) to identify patients eligible for targeted therapies and supports tumor mutation profiling in clinical oncology. The test is performed at Tempus AI, Inc., Chicago, IL.