EarlyDiagnostics’ MethylScan™ Platform Validated in PNAS Study, Demonstrating Multi-Disease Detection from a Single Blood Sample

Independent clinical validation supports EarlyDx’s path toward commercialization

LOS ANGELES--(BUSINESS WIRE)--EarlyDiagnostics, Inc. (“EarlyDx”), a clinical-stage liquid biopsy company developing precision diagnostics, today announced that its proprietary MethylScan™ platform has been validated in a peer-reviewed study published in the Proceedings of the National Academy of Sciences (PNAS). The study demonstrates the platform’s ability to detect multiple cancers, liver diseases, and organ abnormalities from a single blood sample.

The PNAS study evaluated 1,061 patient samples and demonstrated strong performance across multi-cancer detection, liver disease classification, and tissue-of-origin identification. The platform’s methylation-based enrichment reduces sequencing requirements, enabling a more cost-efficient approach than traditional multi-cancer detection methods.

“This publication validates the scientific foundation of our platform and supports our vision of a single, affordable blood test for early disease detection,” said Dr. Jasmine Zhou, Co-founder and CEO of EarlyDx. “We are focused on advancing validation and expanding strategic partnerships to bring this technology into broader clinical use.”

Independent clinical validation has also been demonstrated beyond the PNAS study. In a multi-site, blinded study presented at The Liver Meeting® (AASLD 2025), Dr. Neehar Parikh (University of Michigan) demonstrated the performance of the MethylScan™, combined with AFP, for early detection of hepatocellular carcinoma (HCC). This externally led validation provides real-world evidence. Together with the PNAS publication, these results strengthen the platform’s clinical foundation as the company advances toward broader adoption and commercialization.

EarlyDx is operating a CLIA-certified laboratory, and has secured key reimbursement infrastructure, including a PLA code and CMS pricing determination, for the early detection of HCC. Additional validation programs are underway, including the early detection of lung cancer and ovarian cancer to expand clinical applications and support regulatory pathways.

With peer-reviewed validation, growing clinical evidence, and a cost-efficient platform, EarlyDx is advancing earlier and more accessible approaches to disease detection.

About EarlyDiagnostics

EarlyDiagnostics (EarlyDx) is a clinical-stage precision diagnostics company developing liquid biopsy technologies for early disease detection. Its proprietary MethylScan™ platform uses DNA methylation analysis and machine learning to detect multiple diseases—including cancer, liver disease, and organ abnormalities—from a single blood sample.

EarlyDx operates a CLIA-certified laboratory and is advancing clinical validation and commercialization efforts across additional indications, focused on developing accessible, non-invasive diagnostics designed to improve early detection and support precision medicine.