Tempus AI (NASDAQ: TEM) said the U.S. Food and Drug Administration has approved a tumor-only indication for its xT CDx next-generation sequencing platform, making the Chicago-based precision medicine company the first lab to hold FDA companion diagnostic (CDx) approval for both tumor-only and tumor-normal comprehensive genomic profiling.
What The Approval Changes
xT CDx is a 648-gene tissue-based assay used to profile solid tumors and pick out colorectal cancer patients who may benefit from Erbitux (cetuximab) or Vectibix (panitumumab). Until now the test required a patient-matched normal sample drawn from blood or saliva. The new tumor-only label lets the assay run when that matched sample isn't viable or simply doesn't exist — a common situation in real-world oncology workflows.
Migrating The Solid Tumor Portfolio
The bigger commercial story is reimbursement. Tempus said the approval clears the path for the entire DNA solid tumor portfolio to migrate to FDA-approved assays priced under its current Advanced Diagnostic Laboratory Test (ADLT) framework. "This approval marks a milestone in both our regulatory and reimbursement strategy," said CFO Jim Rogers, who reiterated that Tempus expects an estimated $200 average selling price benefit starting in 2027.
Companion Diagnostics In The AI Era
The xT CDx label adds Tempus to a short list of labs running an FDA-approved comprehensive genomic profiling test with broad solid-tumor coverage, and gives the company more flexibility to compete against established CDx players as oncology shifts toward AI-supported clinical decision making. Chief Scientific Officer Kate Sasser said tumor-only sequencing will complement, not replace, matched workflows: "We recognise 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."
Wider Push Into AI Diagnostics
The expansion lands during a busy stretch for Tempus, which earlier this month extended its push into AI-driven imaging and joined other industry deals reshaping cancer diagnostics. It also comes alongside Aidoc-style foundation-model authorisations and growing FDA throughput on AI/ML-enabled medical devices, where regulators cleared dozens of products in March and April 2026 alone.
Reporting based on coverage from Tempus AI via Business Wire and StockTitan.