PurIST® Algorithm Validated for Pancreatic Cancer First-Line Therapy Selection in Landmark Real-World Study

Real-world evidence demonstrates PurIST's ability to guide first-line treatment decisions and improve outcomes for patients.

Tempus has published the largest real-world validation study for its PurIST® algorithm in JCO Precision Oncology, demonstrating the test’s ability to guide first-line chemotherapy selection in advanced pancreatic ductal adenocarcinoma (PDAC). This validation supports clinical integration of RNA-based subtyping to personalize therapy between FOLFIRINOX and gemcitabine plus nab-paclitaxel regimens.

Drug Profile & Mechanism

PurIST® Algorithm: RNA-based diagnostic test classifying PDAC tumors as “classical” or “basal” molecular subtypes
Target Population: Patients with advanced, unresectable pancreatic ductal adenocarcinoma requiring first-line chemotherapy selection
Platform Integration: Delivered through Tempus xR RNA sequencing platform
Partnership: Collaborative development between Tempus AI and GeneCentric

Regulatory Milestone Details

Publication Venue: JCO Precision Oncology – peer-reviewed validation study
Study Scale: Largest real-world evidence cohort to date (N=931 patients with advanced PDAC)
Clinical Validation: Demonstrates both prognostic and predictive biomarker utility
Regulatory Pathway: Clinical utility validation supporting integration into routine clinical care

Practice Implications

First-line Therapy Selection: Enables biomarker-driven choice between FOLFIRINOX and gemcitabine plus nab-paclitaxel
Classical Subtype Patients: 33% relative risk reduction in death with FOLFIRINOX versus gemcitabine plus nab-paclitaxel (HR=0.67; p<0.009)
Prognostic Stratification: Classical subtype patients show significantly longer median overall survival (11.8 vs 7.0 months, HR=1.86; p<0.001)
Clinical Integration: Addresses major unmet need in PDAC management where robust biomarkers have been lacking

Development Status & Next Steps

Current Availability: PurIST® algorithm clinically available through Tempus xR platform
Real-world Implementation: Study supports integration into routine clinical practice for advanced PDAC patients
Future Development: Validation establishes foundation for broader clinical adoption and potential guideline integration
Market Position: First clinically validated RNA-based subtyping test for PDAC therapy selection

Source: https://sg.finance.yahoo.com/news/tempus-announces-study-jco-precision-123000984.html