Valar Labs, a leader in computational histology and precision oncology, today announced the publication of a major study in the Journal of Clinical Oncology (JCO), a premier, peer-reviewed medical journal published by the American Society of Clinical Oncology.
The report, appearing in the Journal of Clinical Oncology (JCO), uses Valar Labs’ proprietary AI algorithm that analyzes standard H&E-stained pathology slides—universally available for almost every cancer patient—to identify distinct histological signatures in pancreatic cancer that correlate with response to specific therapies.
"This study proves that there is a wealth of predictive information hidden within standard pathology images that the human eye cannot quantify, but AI can," said Viswesh Krishna, Co-founder and CTO of Valar Labs.
Pancreatic cancer remains a difficult-to-treat disease and currently, oncologists have limited tools to decide between the two standard-of-care, first-line chemotherapy options (FOLFIRINOX vs. Gemcitabine/Nab-Paclitaxel), often relying on patient performance status rather than tumor biology. This trial-and-error approach can cost patients valuable time and expose them to unnecessary toxicity.
The paper, titled "Development and Validation of a Computational Histology Artificial Intelligence-Powered Predictive Biomarker for Selection of Chemotherapy in Advanced Pancreatic Cancer," details the development and rigorous validation of Valar Labs’ Vitara Pancreas AI diagnostic test. The study demonstrates the AI’s ability to accurately predict patient response to specific first-line chemotherapy regimens, addressing a critical unmet need in one of the deadliest forms of cancer.
"Publication in the Journal of Clinical Oncology is a significant milestone that underscores the scientific rigor and clinical validity of our approach," said Anirudh Joshi, Co-founder and CEO of Valar Labs. "For too long, first-line treatment decisions in advanced pancreatic cancer have been a bit of a guessing game. By validating our technology with high-quality data from PanCAN and the COMPASS trial, we can provide oncologists with a tool to personalize care and potentially improve outcomes for thousands of patients."
The study utilized data from two prospective cohorts to validate the AI biomarker:
- PanCAN’s Know Your Tumor® initiative: A precision medicine service offered by the Pancreatic Cancer Action Network (PanCAN) that has pioneered molecular profiling for pancreatic cancer patients, accessed via PanCAN’s SPARK health data platform.
- The COMPASS clinical trial: A renowned prospective trial focused on genomics-driven precision medicine for advanced pancreatic cancer.
“This work reflects how AI has the potential to move the field forward by helping guide treatment decisions,” said Anna Berkenblit, MD, MMSc, PanCAN Chief Scientific and Medical Officer.
“By leveraging de-identified patient health data in the PanCAN SPARK health data platform, this initiative underscores how AI-driven data discoveries can not only accelerate research but can also lead to improved patient outcomes,” said Kawther Abdilleh, PhD, PanCAN Director, Data Science and Informatics and co-author.
Following this biomarker validation, Valar Labs is pleased to make the Vitara Pancreas ChemoPredict test available under early access to oncologists for advanced pancreatic cancer patients. Participating providers can order the test to gain actionable insights into which first-line chemotherapy regimen is most likely to benefit each patient.
"Biomarkers to guide choice of first-line chemotherapy in advanced pancreatic cancer have been a decades-long goal for the pancreatic cancer community,” said Dr. Andrew Hendifar, Pancreatic Cancer Medical Director at Cedars Sinai Samuel Oschin Cancer Center, and lead author of the study. “We are excited to share results validating a predictive AI biomarker for this important clinical decision and look forward to integrating the Vitara Pancreas test into our clinical decision making for patients."
Valar Labs is a recognized leader in AI-driven diagnostics for genitourinary cancers, with its flagship Vesta bladder cancer portfolio in use across dozens of leading health systems and cancer centers nationwide. The successful validation of Vitara Pancreas and its availability mark Valar Labs’ expansion into gastrointestinal cancers, further establishing the company as a multi-tumor oncology platform committed to transforming cancer care through artificial intelligence.
For more information on the study or testing for clinical care, please visit www.valarlabs.com.
About Valar Labs
Valar Labs is a precision oncology company using artificial intelligence to reduce the uncertainty in cancer treatment. By analyzing standard pathology slides, Valar’s AI biomarkers predict response to therapy, enabling more personalized and effective treatment decisions.
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