Chicago precision‑medicine player Tempus has scored a fresh nod from the U.S. Food and Drug Administration, landing a tumor‑only indication for its xT CDx next‑generation sequencing platform. In practical terms, that means clinicians can now order the test even when a patient’s matched normal sample, like blood or saliva, is not available. The company dropped the news the morning before the American Society of Clinical Oncology annual meeting.
The new indication applies to the xT CDx assay and, according to the company, makes Tempus the first lab with FDA companion‑diagnostic clearance for both tumor‑only and tumor‑normal comprehensive profiling. In a press release via Business Wire, Tempus said the expanded label allows xT CDx to function as a tumor‑only assay when a matched normal specimen is not viable. “This approval marks a milestone,” Tempus Chief Financial Officer Jim Rogers said, with the company signaling an expected bump to average selling prices starting in 2027.
What The Approval Covers
The device’s original premarket approval and labeling, posted in the FDA devices database, describe xT CDx as a next‑generation sequencing oncology panel that detects substitutions, insertion/deletions and microsatellite instability using FFPE tumor tissue and, when available, matched normal DNA. U.S. Food & Drug Administration records list the PMA (P210011) and prior supplements for xT CDx. As reported by Crain's Chicago Business, the timing puts the regulatory news just ahead of the ASCO annual meeting.
Why Clinicians And Payers Will Notice
Tempus told investors that the tumor‑only clearance allows the company to migrate its DNA solid‑tumor portfolio onto FDA‑approved assays under its Advanced Diagnostic Laboratory Test pricing framework, a shift the company says could raise per‑test revenue. In its May 29 press release, Tempus estimated roughly a $200 per‑test ASP benefit starting in 2027. The company had earlier secured ADLT status for xT CDx from CMS, which set an initial reimbursement rate while private‑payer amounts are collected, per a company investor release (Tempus investor release on CMS ADLT).
Clinical Caveats
Clinical and academic experts caution that tumor‑only sequencing cannot always cleanly separate acquired (somatic) alterations from inherited (germline) variants or clonal hematopoiesis. Paired tumor‑normal analysis often cuts down on false positives and clarifies what follow‑up testing is really needed. In practice, that means some tumor‑only results will still require confirmatory germline testing or extra interpretive work before they can drive treatment decisions. JCO Precision Oncology and recent reviews spell out these limitations and recommended follow‑up paths.
At ASCO, Tempus also presented data on its multimodal foundation models and related work linking AI prognostic tools to clinical‑genomic profiling, a set of disclosures covered in contemporary reporting. Investing.com reported on the presentations alongside the regulatory announcement.
