Company Category: Bioinformatics

Precision Epigenomics® Inc. is an innovative molecular diagnostics company focused on revolutionizing early cancer detection through liquid biopsy testing. By analyzing the epigenome – the complex system that controls expression of DNA – we can detect hidden cancers through screening, study patients for the presence of any residual cancer following treatment, and follow survivors for surveillance of cancer recurrence. With a commitment to advancing the field of molecular diagnostics, we aim to create significant value in the rapidly growing oncology diagnostics market, and, above all, to improve the outcomes and lives of many patients affected by cancer. The Problem In 2025, more than 2 million new cancer cases are projected to be diagnosed in the United States–many of them at late stages. Screening protocols for some cancers such as breast or lung cancer have made some progress, but perform poorly due to patients now knowing which test to take and when, the financial and time commitment, discomfort, and low accuracy. Globally more than 20 Million new cases and 10 Million dying each year from cancer, this is unacceptable. The Solution Liquid biopsies present a minimally invasive sampling process (blood or other fluid collection from a patient) that have been gaining momentum as a validated diagnostic tool. Precision Epigenomics has developed and launched a novel blood-based testing protocol, EPISEEK, which identifies a unique set of DNA biomarkers that consistently change in human cancers, but remain stable in normal tissues. Our proprietary bioinformatics analysis can detect abnormal methylation signals present in more than 60 types of cancer. EPISEEK has demonstrated better accuracy compared to other liquid biopsy tests for detecting brain, pancreas, and lung cancer types, among others. Our qPCR platform is a lower cost structure than commonly used sequencing platforms, has faster turnaround times, is globally scalable, and can be applied to pleural fluid, cerebral spinal fluid, and other biospecimens as our product portfolio expands. With these technology advantages, with our CLIA lab-validated and available EPISEEK™ test, and with a focused pipeline of first-to-market tests for specific medical uses, Precision Epigenomics is positioned to save lives and flourish in the rapidly growing liquid biopsy market. Market Opportunity The U.S. market for early cancer detection is a fast-emerging, multi-billion-dollar opportunity, driven by demand for non-invasive sample collection, favorable regulatory trends, and payer support. As multi-cancer early detection (MCED) technologies gain traction screening asymptomatic and high-risk patients, the market is poised for rapid expansion and long-term disruption of traditional cancer diagnostics. Estimated market size for MCED screening: $74+B; CNS-Glioma detection: $1.1B; Malignant Pleural Effusion: $2.1B; Melanoma: $.5B; Head & Neck: $.5B. Commercialization Strategy With EPISEEK™ now optimized, validated, and orderable from our Tucson-based clinical laboratory, we are implementing our commercialization plans immediately for growth. We are focused on key partnerships that will drive volume: commercial labs, imaging collaborators, large concierge medicine practices, employee benefit programs, and high-risk patient groups. With sales and marketing staff now on board, we have launched targeted programs to build awareness, communicate our differentiation, and grow quickly. In the next two years, we will launch two new products that will be first to market in each category, offering physicians a less-invasive test to improve patient care for pulmonary and glioma patients. These products will be commercialized as broadly reimbursed tests, championed by key opinion leaders, supported by peer-reviewed publications and ongoing clinical data generation, and sold to practicing physicians through a highly specialized product sales force.