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Tucson, AZ — Precision Epigenomics is taking a deliberate, tactical approach as it advances its EPISEEK test in the blood-based cancer screening field. While continuing to offer its Multi-Cancer Early Detection (MCED) assay, the company is also using its EPISEEK platform to actively pursue disease-specific applications where the path to clinical utility and reimbursement may be more direct.
Unlike many prominent MCED assays that rely on genome-wide sequencing, Precision Epigenomics’ technology uses methylation-specific PCR to detect a small panel of specific methylated fragments. COO Dr. Richard Bernert notes this platform is proving to be particularly strong in earlier cancer stages, showing it can outperform next-generation sequencing platforms for some stage I and II cancers in case control studies
Key Data and Strategic Focus
- MCED Validation: The company has presented validation data for its MCED test, emphasizing the use of incidence-adjusted sensitivity—a more conservative metric than simple observed sensitivity—to reinforce confidence in the test’s performance.
- Pancreatic Cancer Results: Recent data on pancreatic cancer detection are promising, showing up to 89% sensitivity in a blinded study, with a 61% combined sensitivity rate for stage I and II cancers. The company highlights that its test appears strong in detecting the disease in stage I and II, crucial for improved outcomes.
- Niche Applications: To pragmatically secure regulatory and reimbursement pathways, Precision Epigenomics is developing applications outside of general MCED. This includes analyzing pleural effusions (fluid around the lungs) for the presence of malignancy where standard of care testing with cytology suffers from poor sensitivity. This intended use has received a $2M SBIR grant. Other niche areas under consideration include epigenetic characterization of brain tumors and pigmented skin lesions.
EPISEEK by Precision Epigenomics offers an MCED option that is similar, safe, effective, and more affordable than competing tests. Ultimately, the company’s PCR-based technology is designed to be globally scalable to serve as an affordable solution to a worldwide problem of delayed detection. “That’s the other advantage of our PCR platform — besides being sensitive, fast, and having lower costs, it is globally scalable,” stated Bernert.
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About Precision Epigenomics
Precision Epigenomics is a molecular diagnostics innovator dedicated to delivering actionable healthcare insights through advanced epigenetic technology and strategic collaboration. With a focus on cutting-edge R&D and partnership integration, the company is transforming diagnostic pathways to improve patient outcomes.
Media Contact:
Jannalee Johnson
Precision Epigenomics