Tempus AI introduced its Immune Profile Score (IPS) test, an AI‑driven biomarker that fuses DNA and RNA data to predict patient response to immune checkpoint inhibitors. The announcement was made on January 27, 2026, and the test is now available as an add‑on to the company’s existing xT DNA and xR RNA assays.
The IPS test was validated in four independent pan‑cancer cohorts, achieving a hazard ratio of 0.45 compared with 0.65 for traditional biomarkers such as tumor mutational burden, microsatellite instability, and PD‑L1. This improvement indicates that IPS can more accurately identify patients likely to benefit from immunotherapy, potentially expanding treatment options for groups that were previously considered unlikely to respond.
In microsatellite‑stable colorectal cancer, IPS identified 13% of patients who achieved strong overall survival with immune checkpoint inhibitors—a group that conventional biomarkers would have missed. In rare metastatic solid tumors, 17% of patients were classified as IPS‑High, opening the possibility of treatment outside existing FDA‑approved indications. These findings demonstrate IPS’s ability to uncover clinically actionable patients across diverse tumor types.
The IPS test is offered as an add‑on to Tempus’s FDA‑approved xT CDx 648‑gene tissue NGS test and its whole‑transcriptome xR RNA sequencing platform. By integrating IPS with these established assays, Tempus enhances the value of its precision‑medicine portfolio and encourages cross‑selling to oncologists and pharmaceutical partners.
Financially, Tempus reported preliminary full‑year 2025 revenue of $316 million, a 31% year‑over‑year increase, with the Insights segment growing 38%. The IPS launch is expected to contribute higher‑margin revenue and deepen relationships with clinicians, positioning the company to capture a larger share of the growing AI‑driven oncology diagnostics market.
The IPS test competes with offerings from Foundation Medicine, Guardant Health, and Caris, while larger players such as Roche and Exact Sciences are also investing in immunotherapy biomarkers. IPS differentiates itself through a multimodal AI algorithm that combines DNA and RNA data, delivering superior predictive accuracy and the capacity to identify patients beyond the reach of conventional biomarkers.
Regulatory status: IPS has been validated in clinical cohorts and is currently offered as a laboratory‑developed test. No FDA clearance has yet been obtained, meaning the company must secure reimbursement and potentially pursue regulatory approval to broaden its commercial reach.
Management emphasized the strategic importance of IPS. Chief Development Officer Halla Nimeiri highlighted the test’s role in personalizing cancer care and empowering physicians with data‑driven insights. Chief Medical Officer Ezra Cohen noted that IPS represents the first multimodal AI biomarker in the immunotherapy space, underscoring Tempus’s commitment to advancing precision medicine.
While the IPS launch marks a significant milestone, Tempus remains unprofitable and has not yet released forward guidance. Investors should monitor upcoming earnings for the impact of IPS on revenue growth, margin expansion, and the company’s path to profitability.
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