Multi-institutional initiative led by Hoag aims to validate Tu-Stroma, a novel blood-based biomarker designed to intercept ovarian cancer at its preinvasive stage
The Hoag Family Cancer Institute and the Hoag Translational Research Department—a resident of University Lab Partners—have been awarded an approximately $2.5 million NIH/NCI R01 grant to validate a first-in-class, blood-based diagnostic biomarker platform. The multi-site project, “Intercepting Ovarian Cancer at Its Earliest Stage: Validation of Tu-Stroma as a Blood-Based Diagnostic Biomarker,” places Hoag at the center of a national effort to fundamentally shift when and how high-grade serous ovarian cancer is detected.
The program aims to move cancer detection upstream to the cellular, fallopian-tube precursor stage—years before invasive tumors become clinically apparent, radiographically detectable, or surgically advanced. By identifying blood-based biological signals in the preinvasive window, potentially 4 to 8 years before Stage I invasive ovarian cancer is established, the platform seeks to establish a new paradigm of cancer interception for high-risk patients and those navigating critical decisions regarding surveillance, triage, or risk-reducing surgery.
Moving Beyond Conventional Early Detection
Unlike conventional diagnostic tests that look for disease after an invasive tumor has already formed, the Tu-Stroma platform focuses on intercepting cancer at its biological starting point. High-grade serous ovarian cancer is notoriously lethal because it is typically diagnosed in late stages after abdominal dissemination, where surgical options are complex and recurrence rates remain high.
The platform targets microscopic precursor lesions within the fallopian tube, providing clinicians with actionable molecular data long before anatomical distortion occurs:
Preinvasive Interception: Capturing early fallopian-tube precursor signals 4–8 years before invasive malignancy develops.
Informed Surgical Triage: Assisting women with indeterminate pelvic masses or complex risk profiles in distinguishing between urgent oncologic intervention and safe monitoring.
Precision for High-Risk Populations: Offering women with hereditary cancer predispositions (e.g., BRCA mutations or strong family histories) biological clarity to guide the optimal timing of preventive surgeries.
“Early detection can no longer mean finding a tumor once it has already established itself,” said Dr. Rajan Gogna, co-principal investigator and co-architect of the platform at Hoag Family Cancer Institute. “By capturing molecular warnings in circulation while lesions remain microscopic and localized to the fallopian tube, we have a genuine opportunity to change clinical outcomes and intercept cancer before it becomes life-threatening.”
A Nationally Recognized Research Program
The scientific rigor of the program earned an extraordinary 1st-percentile score during NIH peer review, placing the application among the very top tier of federally evaluated cancer research proposals across the United States.
The grant designates Hoag not merely as a participating study site, but as the lead institution directing a national translational research coalition in partnership with prominent academic medical centers across the country.
“This recognition from the National Cancer Institute reinforces that Hoag is driving cancer research at the highest federal standard,” said Dr. Esha Madan, co-principal investigator and co-developer of the Tu-Stroma platform. “Translating laboratory discoveries into clinical solutions requires robust validation across diverse patient cohorts. Working alongside world-class academic partners allows us to rigorously establish the diagnostic fidelity of this biomarker platform.”
National Collaborative Leadership
Hoag serves as the lead coordinating institution for a multi-center collaborative network featuring prominent investigators in ovarian cancer biology, pathology, and translational diagnostics:
Esha Madan, Ph.D. — Lead Principal Investigator & Platform Co-Architect, Hoag Family Cancer Institute
Rajan Gogna, Ph.D. — Lead Principal Investigator & Platform Co-Architect, Hoag Family Cancer Institute
Andrew Godwin, Ph.D. — Professor and Division Director of Genomic Diagnostics, University of Kansas Medical Center
Kenneth Nephew, Ph.D. — Professor of Cellular & Integrative Physiology, Indiana University School of Medicine
Bo Rueda, Ph.D. — Director of the Vincent Center for Reproductive Biology, Massachusetts General Hospital / Harvard Medical School
Clinical Roadmap and Translational Horizon
The multi-year NIH/NCI-funded program focuses on prospectively validating the Tu-Stroma platform across multi-institutional clinical cohorts, analyzing patient biofluids, pathology specimens, and molecular markers.
As prospective validation advances, Hoag plans to leverage the infrastructure established by this grant to anchor an expanded translational oncology pipeline—connecting biospecimen banking, genomic diagnostics, and early-detection clinical trials directly with bedside patient care in Southern California and beyond.
