Extracellular Vesicle and Particle (EVP) Protein Platform for Diagnosis and Prognosis of Cancer Subtypes

Background & Unmet Need

• Pioneering work of Dr. Lyden showed that cancer cells secrete protein-rich EVPs (exosomes) that presage and prepare the metastatic niche
• Dr. Lyden and collaborators have analyzed 426 samples for protein content of EVPs from different sources (tumor/healthy samples; plasma; tissue explants, etc.)
• Significant differences between proteins in tissues and plasma of cancer vs healthy patients and cancer subtypes have been found, enabling a range of diagnostic and prognostic tests
• Unmet Need:
• Diagnosis of Cancer of Unknown Primary Origin (CUP; ca. 2-5% of all cancers; poor prognosis)
• Distinguishing malignant vs non-malignant growths (over 5M biopsies each year)
• Cancer screening of at-risk patients (>50)

Technology Overview

• The Technology: Plasma EVP extraction and MS analysis workflow for the detection of multiple cancer subtypes
• Biomarker sets distinguishing plasma of patients: tumor vs. non-tumor; cancer types; malignant vs. premalignant tumors
• PoC Data: Distinguishes plasma from patients with and without tumor with 95% sensitivity and 90% specificity
• Identifies primary tumors in plasma: breast, colorectal, lung, pancreatic cancer, mesothelioma
• Distinguishes malignant vs. premalignant patients (e.g., PDAC vs. IMPN; myelodysplasia vs. leukemia)
• Additional validation of the workflow is ongoing

Technology Applications

• CUP primary tumor identification to inform treatment strategy and prolong patient survival
• Malignant vs. premalignant test that replaces the need for invasive biopsies
• Screening test for rapid, early tumor detection

Technology Advantages

• Rapid, accurate, and non-invasive tests
• Fits into current clinical decision-making and delivers immediate value to physicians and patients
• Distinguishes plasma from patients with and without tumor with 95% sensitivity and 90% specificity
• Applicable to detection of numerous tumor types, including breast, colorectal, lung, pancreatic cancer, and mesothelioma

Figure 1: Overview of the EVP platform for diagnosis and prognosis of multiple cancer subtypes.