xT CDx

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Next generation sequencing oncology panel, somatic or germline variant detection system

FDA applicant

Tempus AI, Inc.

PMA Number

P210011 ↗

FDA Product Code

PQP

Device Class

Class III

Advisory Committee

Pathology

FDA Decision

APPR Approved

• What types of specimens can the xT CDx analyze, and how are they processed?

  The xT CDx analyzes DNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissue, matched normal blood, or saliva specimens from patients with solid malignant neoplasms. It is a single-site assay performed exclusively at Tempus Labs, Inc. in Chicago, IL, meaning the testing is conducted centrally rather than at the point of care or in a local lab.

• Is the xT CDx intended to guide treatment decisions for specific therapies, and if so, how?

  Yes, the xT CDx is authorized as a companion diagnostic (CDx) to identify patients who may benefit from targeted therapies aligned with the approved therapeutic product labeling. It detects genetic alterations in 648 genes, including substitutions, insertions, deletions, and microsatellite instability (MSI) status, to help clinicians select eligible patients for therapies listed in the Companion Diagnostic Indications table. However, findings beyond these specific indications are not prescriptive for any treatment.

• How does the xT CDx differ from other genetic testing panels in terms of specimen requirements?

  Unlike some panels that may require fresh tissue or specific preservation methods, the xT CDx is designed to work with DNA extracted from FFPE tumor samples, matched normal blood, or saliva—commonly available specimen types in oncology. This flexibility is particularly useful for retrospective testing or cases where fresh tissue is unavailable, as FFPE samples are routinely archived in clinical settings.

• Who performs the xT CDx test, and what role does the healthcare professional play in its use?

  The xT CDx is performed exclusively at Tempus Labs, Inc. in Chicago, IL, as a single-site assay. Qualified healthcare professionals use the results in accordance with oncology guidelines to guide treatment decisions, particularly for therapies listed in the Companion Diagnostic Indications table. While the test provides genomic profiling, it is not intended to prescribe treatment on its own—clinicians interpret results within broader clinical context.

• What regulatory pathway was followed for the approval of the xT CDx, and what does that mean for its use?

  The xT CDx was authorized through the FDA’s Premarket Approval (PMA) process under PMA number P210011, which is the highest level of regulatory review for high-risk medical devices. This means the device has undergone rigorous evaluation to ensure its safety and effectiveness for its specified use as a companion diagnostic to identify patients eligible for targeted therapies based on genetic alterations detected in 648 genes. Its use is strictly limited to the parameters outlined in the FDA approval.