Key Highlights:
- $TEM + $VSTM Collaboration: Tempus and Verastem partner to develop a CDx assay for KRAS-mutant recurrent low-grade serous ovarian cancer (LGSOC), supporting the first-ever FDA-approved targeted combination therapy.
- CDx Embedded in Phase 3 Trial: Tempus’ FDA-approved xT assay used to prospectively stratify KRAS status in global RAMP-301 study—marking a major leap in AI-driven diagnostics for rare gynecologic cancers.
- Unlocking AI’s Power in Precision Medicine: Tempus’ AI-enabled diagnostic platform stands as a model for biopharma collaborations seeking accelerated pathways in oncology drug development.
FDA milestone: a new era for targeted LGSOC therapies
Tempus AI and Verastem Oncology have joined forces to tackle one of the most underserved segments in gynecologic oncology—recurrent KRAS-mutant LGSOC. Through this collaboration, Tempus’ xT CDx assay was used to confirm KRAS status in the pivotal RAMP-201 trial that formed the basis for the FDA’s accelerated approval of avutometinib plus defactinib—the first targeted combination for this mutation type. This development marks not just a clinical win, but a regulatory benchmark in the use of AI-enhanced companion diagnostics for rare cancers.
xT CDx: Tempus’ AI diagnostic engine at the forefront
The xT CDx assay isn’t just another next-gen sequencing tool—it’s a scalable AI-powered engine analyzing 648 genes, MSI status, and mutation signatures in tumor and matched normal DNA. Now embedded in Verastem’s Phase 3 RAMP-301 trial, xT CDx is being used prospectively to define KRAS-mutant cohorts. This approach not only validates real-time AI-based patient stratification, but also sets a precedent for how diagnostics and therapeutics can evolve in sync through precision trial design.
Verastem’s strategic vision: beyond approval to market leadership
Verastem’s ability to rapidly convert clinical promise into FDA validation demonstrates how nimble biopharma companies can deliver transformative impact in niche oncology indications. With a targeted therapy already FDA-approved and a companion CDx in development, the company exemplifies a model of accelerated therapeutic-commercial integration. Their long-term commitment to building a robust CDx framework speaks to a future where molecular diagnostics are embedded from discovery to delivery.
Tempus’ bigger bet: industrializing precision medicine with AI
Backed by one of the world’s largest multimodal datasets, Tempus is quietly industrializing precision medicine. Its diagnostics-as-platform strategy is designed to streamline drug development for pharma, while simultaneously empowering providers with actionable insights at the point of care. Collaborations like the one with Verastem show how AI-driven molecular diagnostics can leap from academic research to regulatory-grade clinical utility—and eventually to mainstream adoption.
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