Tempus AI’s xT CDx Secures FDA Tumor-Only Approval for 648-Gene Assay, $200 ASP Uplift
TEM•Tempus AI’s xT CDx sequencing assay gained FDA tumor-only approval, making it the first lab cleared for tumor-only and tumor-normal profiling across 648 genes. The expansion enables migration of its DNA solid tumor portfolio to unified ADLT pricing with an expected $200 ASP uplift from 2027.
1. FDA Approval Milestone
Tempus AI announced FDA authorization of its xT CDx next-generation sequencing assay for tumor-only indication, marking the first instance of a companion diagnostic cleared for both tumor-only and tumor-normal comprehensive genomic profiling. This regulatory clearance allows testing without a matched normal sample when blood or saliva specimens are not available.
2. xT CDx Platform Details
The xT CDx platform analyzes 648 genes from formalin-fixed paraffin-embedded tumor tissue, detecting SNVs, MNVs, INDELs and microsatellite instability status from tumor specimens alone. It serves as a companion diagnostic for colorectal cancer therapies Erbitux (cetuximab) and Vectibix (panitumumab) and supports broader molecular profiling in solid malignancies.
3. ADLT Pricing and Financial Impact
With FDA tumor-only approval in place, Tempus will migrate its entire DNA solid tumor portfolio to FDA-approved assays priced under its ADLT framework. Tempus projects an approximate $200 average selling price benefit starting in 2027, reflecting streamlined regulatory and reimbursement alignment.
4. Clinical and Strategic Implications
The expanded label enhances clinical flexibility by removing the requirement for matched normal samples, improving access in settings where blood or saliva collection is impractical. This milestone strengthens Tempus’s market positioning in precision oncology diagnostics and underpins long-term revenue growth potential.
