MethylScan
MethylScan™ is EarlyDiagnostics proprietary next-generation epigenomic platform.
MethylScan™
MethylScan™ is EarlyDiagnostics proprietary next-generation epigenomic platform for blood-based disease detection, enabling cancer screening, biomarker discovery, patient risk stratification, and minimal residual disease (MRD) monitoring across oncology and liver disease.
At the core of the platform is the MethylScan™ assay, a highly cost-effective cfDNA methylome sequencing technology that profiles millions of DNA methylation sites across the genome from a single blood sample. Powered by advanced AI and machine learning algorithms, MethylScan™ identifies disease-specific methylation signatures to detect cancer and other diseases at their earliest stages with high accuracy.
Across multiple cancer types, MethylScan™ has consistently demonstrated high sensitivity while maintaining 98% specificity (Figure 1). The unified platform has been validated in liver, lung, ovarian, and gastric cancers, supporting its broad applicability for blood-based early cancer detection.
Fig. 1 Sensitivity of MethylScan™ for Detecting Multiple Cancer Types at 98% Specificity.
The first clinical application of the platform is MethylScan™ HCC, a blood-based test for hepatocellular carcinoma (HCC) surveillance in patients at risk for HCC, including those with cirrhosis or chronic hepatitis B virus (HBV) infection. Clinical studies have demonstrated that MethylScan™ HCC outperforms the current standard-of-care surveillance strategy of ultrasound plus alpha-fetoprotein (AFP).2 The test is currently offered as a CLIA laboratory-developed test (LDT).
Built on a unified assay and computational framework, MethylScan™ is readily adaptable to additional clinical applications. EarlyDiagnostics is actively expanding the platform to multi-cancer early detection, liver disease, and minimal residual disease (MRD) monitoring.
References:
- Zeng W, Liu CC, Li S, Zhou Y, Stackpole ML, Xiao Y, et al. Toward the simultaneous detection of multiple diseases with a highly cost-effective cell-free DNA methylome test. Proc Natl Acad Sci U S A. 2026;123(15):e2518347123.
- Parikh ND, Liu CC, DeMaio M, Yeh AH, Stackpole ML, Li S, Agopian VG, Li W, Zhou XJ, Ni X, Lok AS, Han SB. Hepatol Commun. 2026 Jun 19;10(7):e0987.
