Tumor-DNA detection in plasma & urinary EVs for non-invasive cancer monitoring & treatment

PROBLEM

Prostate cancer (PCa) and urothelial cancers (UC) are among the most commonly diagnosed malignancies in aging adults, and their management is characterized by prolonged, costly, and invasive surveillance pathways. Both diseases exhibit marked molecular heterogeneity that drives prognosis, treatment response, recurrence, and metastasis. Despite decades of research, there remains a critical lack of reliable biomarkers to monitor disease progression in men with PCa on active surveillance, to detect recurrence in patients with non-muscle invasive bladder cancer undergoing bladder preservation, and to predict or track response to systemic therapy in muscle-invasive disease. Current surveillance relies heavily on procedures that impose significant physical and economic burden, including repeated imaging, invasive biopsies, and frequent cystoscopies, thus highlighting the need to identify predictive biomarkers and improve surveillance protocols for PCa and UC patients.

SOLUTION

OSU physician, Dr. Akshay Sood, has developed a novel liquid biopsy platform centered on organ-specific extracellular vesicle (EV)-derived tumor DNA obtained from urine and plasma. This OSU technology isolates tumor-specific EVs shed directly by PCa and UC with high fidelity for analysis. The molecular payload within these EVs is analyzed using a highly sensitive tumor-informed assay to enable early detection of progression, recurrence, and treatment response via a non-invasive sample.

APPLICATIONS

  • Active surveillance monitoring in low-risk PCa patients, and for recurrence and progression in non-muscle invasive UC
  • Response monitoring and treatment optimization for patients undergoing chemotherapy, immunotherapy, or chemoradiation for muscle-invasive UC
  • Post-treatment surveillance following radical surgery for PCa or UC
  • Precision risk stratification and prognostics to enable a personalized approach

ADVANTAGES

  • Non-invasive sample collection using blood or urine for improved patient comfort and adherence to monitoring
  • Earlier and more accurate detection of disease persistence, recurrence, and progression
  • Enhanced sensitivity in localized disease compared to plasma ctDNA alone
  • Tumor-specific molecular insight by capturing heterogeneity often missed by tissue sampling

Seeking opportunities for out-licensing, co-development, and collaboration

Patents

Patent # Title Country
PCT/US2026/024527 METHODS OF USING TUMOR-TISSUE GUIDED TUMOR-DNA DETECTION PCT (Not Applicable)

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