FDA Approves Tempus’ Tumor Only xT CDx

Tempus AI Inc. has earned U.S. Food and Drug Administration (FDA) approval for a tumor-only indication for its xT CDx next-generation sequencing platform. Thus, Tempus is reportedly the first laboratory to hold FDA companion diagnostic (CDx) approval for both tumor-only and tumor-normal comprehensive genomic profiling.

Tempus xT CDx is a 648-gene tissue-based assay intended for the molecular profiling of all solid tumor malignancies. It also serves as a companion diagnostic to identify colorectal cancer patients who may benefit from targeted therapies, specifically Erbitux (cetuximab) and Vectibix (panitumumab).

While xT CDx previously required a patient’s matched normal sample, this regulatory milestone allows the test to run as a tumor-only assay when a matched normal specimen (blood or saliva) is not viable or available. This approval paves the way for Tempus to migrate its entire DNA solid tumor portfolio to FDA-approved assays priced under its current ADLT (Advanced Diagnostic Laboratory Test) pricing.

“This approval marks a milestone in both our regulatory and reimbursement strategy, as this allows the migration of our entire solid tumor DNA portfolio to be under unified ADLT pricing,” Tempus Chief Financial Officer Jim Rogers stated. “As we have previously highlighted, we expect an estimated $200 ASP benefit beginning in 2027 as a result of this approval.”

xT CDx is a qualitative Next Generation Sequencing (NGS)-based in-vitro diagnostic device intended for use to detect substitutions (single nucleotide variants (SNVs) and multi-nucleotide variants (MNVs)) and insertion and deletion alterations (INDELs) in 648 genes in patients with previously diagnosed solid malignant neoplasms. The assay uses DNA isolated from Formalin-Fixed Paraffin Embedded (FFPE) tumor tissue specimens and, when available, patient-matched blood or saliva specimens. Additionally, the device detects microsatellite instability (MSI) status based on a genomic signature from the tumor specimen only. The test is intended as a companion diagnostic (CDx) to identify patients who may benefit from treatment with the targeted therapies listed in the Companion Diagnostic Indications table in accordance with the approved therapeutic product labeling. Additionally, xT CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms.

“Our goal is to support clinicians with advanced genomic profiling options,” Tempus Chief Scientific Officer Kate Sasser, Ph.D., said. “With FDA approval for both tumor-only and tumor-normal comprehensive genomic profiling, Tempus xT CDx provides flexibility for a range of clinical scenarios. While tumor-normal matched sequencing remains an important approach, we recognize that a matched sample is not always available, and now patients can still benefit from an FDA-approved test that can help inform treatment decisions.”

Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and, in parallel, facilitates the discovery, development, and delivery of optimal therapeutics.