CHICAGO - Tempus AI, Inc. (NASDAQ:TEM) announced today that the U.S. Food and Drug Administration has approved a tumor-only indication for its xT CDx next-generation sequencing platform, according to a press release statement.
The approval allows the xT CDx test to function without requiring a patient’s matched normal sample when blood or saliva specimens are not available. The company stated it is the first laboratory to hold FDA companion diagnostic approval for both tumor-only and tumor-normal comprehensive genomic profiling.
The xT CDx is a 648-gene tissue-based assay designed for molecular profiling of solid tumor malignancies. It serves as a companion diagnostic to identify colorectal cancer patients who may benefit from Erbitux (cetuximab) and Vectibix (panitumumab) therapies.
Jim Rogers, Chief Financial Officer at Tempus, said the approval enables the migration of the company’s solid tumor DNA portfolio to unified Advanced Diagnostic Laboratory Test pricing. The company expects an estimated $200 average selling price benefit beginning in 2027 as a result of the approval.
The test detects substitutions and insertion and deletion alterations in 648 genes using DNA isolated from formalin-fixed paraffin embedded tumor tissue specimens. When available, the assay can also use patient-matched blood or saliva specimens. The device detects microsatellite instability status based on a genomic signature from the tumor specimen only.
Kate Sasser, Chief Scientific Officer at Tempus, stated the approval provides flexibility for clinical scenarios where matched samples are not available, while tumor-normal matched sequencing remains an important approach.
The test is intended for use by qualified healthcare professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms.
In other recent news, Tempus AI, Inc. has received FDA approval for its xT CDx next-generation sequencing platform, allowing the company to become the first laboratory with FDA companion diagnostic approval for both tumor-only and tumor-normal comprehensive genomic profiling. This approval permits the test to operate as a tumor-only assay when a matched normal specimen is unavailable. Tempus has also expanded its AI platform to address six new cancer types, including breast, colorectal, ovarian, prostate, and urothelial cancers. A study presented at the 2026 American Society of Clinical Oncology Annual Meeting demonstrated the platform’s effectiveness in early-stage non-small cell lung cancer patients. Additionally, the company has upgraded its Tempus Hub platform by integrating generative AI capabilities, enhancing real-time patient data access for healthcare providers. In another development, Tempus launched the ArteraAI Prostate Test for metastatic hormone-sensitive prostate cancer patients, which analyzes clinical information and biopsy images to estimate prostate cancer-specific mortality risk. These advancements highlight Tempus AI’s ongoing efforts to innovate and expand its offerings in the healthcare sector.
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