Gemcitabine Hydrochloride

New AI diagnostic, Vitara Pancreas ChemoPredict, can select optimal first-line treatment for advanced pancreatic cancer patients. PALO ALTO, Calif.--(BUSINESS WIRE)--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. Article: Development and Validation of a Computational Histology Artificial Intelligence-Powered Predictive Biomarker for Selection of Chemotherapy in Advanced Pancreatic Cancer For more information on the study or testing for clinical care, please visit . 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. Contacts Media Relations +1 (888) 862-0232 media@valarlabs.com

Device Delivers Non-invasive Therapy and Supports Care at Home White Oak, Md., Feb. 12, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration has approved a first-of-its-kind device for the treatment of adult patients with locally advanced pancreatic cancer. Optune Pax, developed by Novocure, is a portable, non-invasive device that delivers alternating electrical fields, known as tumor treating fields (TTFields), to the abdomen. TTFields work by physically disrupting the rapid cell division that is characteristic of cancer cells, while minimizing damage to healthy tissue. “Having treated many patients with pancreatic cancer, I know how difficult the diagnosis can be. The pancreatic cancer community deserves better therapeutic options,” said FDA Commissioner Marty Makary, M.D., M.P.H. “The FDA is working tirelessly to bring potentially promising therapies to people who need them.” The approval reflects the FDA’s unwavering commitment to advancing safe and effective medical devices that address chronic diseases and improve the lives of Americans and is also aligned with the FDA’s Home as a Health Care Hub Initiative , which focuses on advancing the development of innovative, patient-centered devices that fit more seamlessly into people’s daily lives at home. “Pancreatic cancer is one of the most challenging cancers to treat, and patients have long needed new therapeutic options,” said Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. “This approval provides a novel, non-invasive approach that can be integrated into patients’ daily lives, expanding access to cancer care beyond traditional clinical settings.” According to information published by the National Cancer Institute , pancreatic cancer was expected to result in approximately 67,440 new diagnoses and 51,980 deaths in the U.S. in 2025. Pancreatic cancer accounts for roughly 3.3% of all new cancer cases but represents a disproportionately large share of cancer deaths due to its late detection, aggressive disease behavior, and limited treatment options. The therapy is administered through electrically insulated adhesive patches that are placed on the patient’s skin and connected to an electric field generator. Device treatment technological parameters are preset by the manufacturer and cannot be adjusted by the patient or physician. Patients are trained on how to use the device, including how to recharge and replace device batteries, connect the device to an external power supply, place the adhesive patches in the appropriate positions on the body, and replace the transducer arrays at least twice per week. The device is designed to be worn with the generator carried in a specially designed bag, allowing patients to receive continuous treatment while going about their normal daily activities. Optune Pax was approved through the premarket approval (PMA) pathway, the FDA’s most rigorous review process for medical devices. The FDA’s approval of Optune Pax is based on data from a pivotal clinical study conducted under an Investigational Device Exemption. The randomized and controlled study followed adult patients with locally advanced pancreatic cancer for up to five years. The results showed that the addition of TTFields to standard of care chemotherapies gemcitabine and nab-paclitaxel (GnP) improved Overall Survival by approximately two months compared to GnP alone. Localized skin reactions were the most common device-related risks observed in the study. The results of this study formed the basis for the FDA’s PMA approval decision. The FDA granted Breakthrough Device designation for the Optune Pax device in December 2024. A breakthrough designation is meant to expedite the development and review of devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Contact Info U.S. Food and Drug Administration FDAPressAlerts@fda.hhs.gov +1 202-690-6343