Tempus AI recently announced that the US Food and Drug Administration (FDA) has granted approval for a tumor-only indication for its xT CDx next-generation sequencing platform. With this expanded label, Tempus is 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 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.

Jim Rogers, Chief Financial Officer (CFO), Tempus, said, “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. As we have previously highlighted, we expect an estimated USD 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 in the detection of 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. Genomic findings other than those listed in the Companion Diagnostic Indications table are not prescriptive or conclusive for labeled use of any specific therapeutic product.

Kate Sasser, PhD, Chief Scientific Officer, Tempus, said, “Our goal is to support clinicians with advanced genomic profiling options. 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 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.”