Biopharma Solutions

EarlyDiagnostics partners with biopharmaceutical companies to accelerate biomarker discovery, clinical development, and precision medicine. Leveraging our proprietary liquid biopsy technologies, including MethylScan™ genome-wide cfDNA methylation analysis and cfSNV mutation profiling,^1,2 we provide comprehensive genomic and epigenomic solutions to support translational research, clinical trials, and companion diagnostic development.

Biomarker Discovery

Our integrated genomics platform combines genome-wide methylation profiling, mutation analysis, and AI-powered computational algorithms to identify and validate blood-based biomarkers for oncology, liver disease, and other therapeutic areas.

Minimal Residual Disease (MRD) Monitoring

MethylScan™ enables highly sensitive, tumor-informed or tumor-naïve MRD assessment using genome-wide methylation signatures.³ The platform supports longitudinal monitoring of treatment response, detection of disease recurrence, and pharmacodynamic assessment in clinical trials.

Tissue-of-Origin (TOO) Analysis

Cell-free DNA methylation preserves tissue-specific epigenetic signatures, enabling accurate tissue-of-origin determination.⁴ Our platform supports cancer classification,⁵ investigation of cancers of unknown primary (CUP), monitoring of therapy-induced tissue injury, and detection of histologic transformation during treatment.

Companion Diagnostic (CDx) Development

Our CLIA-ready laboratory workflow and scalable sequencing platform support the co-development and clinical validation of biomarker-driven companion diagnostics, helping biopharma partners accelerate regulatory approval and precision medicine implementation.

Whether you are developing targeted therapies, immunotherapies, or novel diagnostics, EarlyDiagnostics provides flexible liquid biopsy solutions to support every stage of translational research and clinical development.

For partnership opportunities, please contact [email protected].

References:

1. 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.
2. Li S, Noor ZS, Zeng W, Stackpole ML, Ni X, Zhou Y, et al. Sensitive detection of tumor mutations from blood and its application to immunotherapy prognosis. Nat Commun. 2021;12(1):4172.
3. Li S, Zeng W, Ni X, Liu C, Zhou Y, Stackpole M, cfTrack-methyl: A personalized approach using cfDNA methylomes for ultra-sensitive MRD detection. Cancer Res 2025;85(8_Supplement_1):3244.
4. Li S, Zeng W, Ni X, Liu Q, Li W, Stackpole ML, et al. Comprehensive tissue deconvolution of cell-free DNA by deep learning for disease diagnosis and monitoring. Proc Natl Acad Sci U S A. 2023;120(28):e2305236120.
5. Li S, Li W, Liu B, Krysan K, Dubinett SM. Noninvasive Lung Cancer Subtype Classification Using Tumor-Derived Signatures and cfDNA Methylome. Cancer Res Commun. 2024;4(7):1738-47.