Tempus AI secures expanded FDA approval for cancer sequencing platform

Tempus AI (NASDAQ:TEM) announced that the U.S. Food and Drug Administration (FDA) has granted approval for a tumor-only indication for its xT CDx next-generation sequencing platform.

The regulatory milestone makes the Chicago-based precision medicine company the first laboratory to hold FDA companion diagnostic approval for both tumor-only and tumor-normal comprehensive genomic profiling.

The xT CDx platform is a 648-gene tissue-based assay designed for the molecular profiling of all solid tumor malignancies.

In addition to broad profiling, the assay serves as a regulatory-approved companion diagnostic to identify colorectal cancer patients who may benefit from targeted therapies, specifically Erbitux (cetuximab) and Vectibix (panitumumab).

While the xT CDx platform previously required a patient’s matched normal sample—typically derived from blood or saliva—to subtract inherited genetic variations, the newly expanded label allows the test to function as a standalone tumor-only assay.

This option provides crucial clinical flexibility for oncology teams when a matched normal specimen is either unavailable or unviable due to sample degradation or collection constraints.

The regulatory clearance carries significant operational and financial implications for Tempus AI.

The approval allows the company to migrate its entire DNA solid tumor portfolio into FDA-approved assays.

These assays will be positioned under its existing Advanced Diagnostic Laboratory Test (ADLT) pricing framework, which standardizes commercial reimbursement paths.

Tempus executive leadership indicated that this unified regulatory and reimbursement strategy is expected to yield an estimated $200 average selling price benefit beginning in 2027.