Earlydx
1 known investors
EarlyDx develops non-invasive liquid biopsy tests aimed at early cancer detection and precision medicine. The company positions its tests as accurate and affordable diagnostics.
Also known as EarlyDiagnostics · EarlyDx
Founders & leadership
Investors · 1
Company profile
researched Aug 2026EarlyDiagnostics (EarlyDx) is a liquid biopsy company developing blood-based tests and computational tools that analyze cell-free DNA (cfDNA) for early disease detection, patient risk stratification, precision medicine and longitudinal health monitoring. Its core platform, MethylScan, is a next-generation epigenomic (DNA methylation) platform positioned for cancer screening, biomarker discovery, risk stratification and minimal residual disease (MRD) monitoring across oncology and liver disease. The company describes its aim as transforming cfDNA into whole-body molecular insights from a single blood draw.
The product portfolio includes CancerRadar, a blood test for detecting and localizing cancer; MethylScan HCC, a methylation-plus-alpha-fetoprotein assay for hepatocellular carcinoma surveillance; cfSNV, a computational tool for calling mutations directly from blood; cfTrack, for non-invasive monitoring of cancer MRD, recurrence and evolution; and EarlyDx-Cloud, a "one-stop shop" bioinformatics solution that other diagnostic companies can use to offer liquid biopsy tests for cancer detection, therapy selection and treatment monitoring.
The company operates a clinical laboratory that is CLIA-certified and licensed by the State of California (December 2024) and accredited by the College of American Pathologists (October 2025, CAP #9954593). In April 2025 the American Medical Association published a CPT Proprietary Laboratory Analysis (PLA) code for MethylScan HCC.
Founding story
EarlyDx was co-founded by academic researchers in bioinformatics and statistics: Jasmine Zhou, Professor of Pathology and Laboratory Medicine at UCLA and leader of the NIH-funded UCLA Center for the Early Detection of Liver Cancer; Wing Hung Wong, a Stanford University professor, National Academy of Sciences member and previous co-founder of Bina Biotechnologies (acquired by Roche in 2014); and Peter Li, an adjunct associate professor at UCLA working on machine learning and clinical informatics of liquid biopsy.
Business model
EarlyDx combines a laboratory-developed diagnostic testing business, run through its own CLIA-certified and CAP-accredited clinical laboratory, with a software/bioinformatics offering (EarlyDx-Cloud) supplied to other diagnostic companies so they can run liquid biopsy tests. A third-party investor profile characterizes the company's model as B2B SaaS.
Diagnostic test services delivered through its own clinical laboratory, supported by reimbursement infrastructure (a CPT PLA code for MethylScan HCC), alongside a bioinformatics platform licensed to other diagnostics companies. Non-dilutive federal funding via NIH SBIR contracts/grants and an NIH U01 grant also supports development.
Traction
Reported milestones include NIH SBIR Phase II grant and contract awards (September 2022 and September 2023), an NIH U01 grant with UCLA and MD Anderson for multi-cancer early detection using cfDNA methylome analysis and membership in the NIH Liquid Biopsy Consortium (October 2023), CLIA certification and California state licensure (December 2024), a CPT PLA code for MethylScan HCC (April 2025), CAP accreditation (October 2025), late-breaking oral presentation data at AASLD's The Liver Meeting 2025, and clinical validation publications in PNAS (May 2026) and Hepatology Communications (July 2026).
Latest developments
In July 2026 the company announced publication of clinical validation results for MethylScan HCC in Hepatology Communications, reporting 73% sensitivity at 92% specificity for early-stage HCC within Milan criteria. In May 2026 it announced PNAS publication showing MethylScan can detect multiple cancers, liver diseases and organ abnormalities from a single blood sample. In April 2026 it exhibited at AACR 2026 and sought collaborations and partnerships.
▸Full profile — market position, technology, go-to-market, geography, history, risks & controversies
Market position
EarlyDx is an early-stage, seed-stage liquid biopsy diagnostics company operating in the multi-cancer early detection and cfDNA monitoring field; a third-party investor profile lists Delfi Diagnostics, Acuamark Diagnostics, Foresight Diagnostics, Precede Biosciences and AgenDx Biosciences as similar companies.
Differentiation rests on a methylation-based cfDNA platform with published validation data (Nature Communications 2022, recognized among that journal's "Top 25 Health Sciences Articles of 2022"; PNAS 2023 and 2026), reported performance of 73% sensitivity at 92% specificity for early-stage HCC within Milan criteria, a granted CPT PLA code for MethylScan HCC, an accredited clinical laboratory, and an accompanying bioinformatics platform sold to other diagnostics providers rather than tests alone.
Technology
The technology centers on cell-free DNA analysis, primarily methylome profiling via the proprietary MethylScan epigenomic platform, coupled with machine learning and next-generation sequencing bioinformatics. Related computational methods include cfSNV for mutation calling directly from blood, cfTrack for MRD/recurrence monitoring, and deep-learning-based tissue deconvolution of cfDNA for disease diagnosis and monitoring (published in PNAS in 2023). Underlying methods have been published in Nature Communications (2022) and PNAS, and the MethylScan HCC assay combines DNA methylation signals with alpha-fetoprotein.
Go-to-market
The company pursues clinical validation through peer-reviewed publication and conference presentations (AASLD's The Liver Meeting 2025, AACR 2026), reimbursement groundwork via a CPT PLA code, laboratory credentials (CLIA, California state license, CAP accreditation), academic and consortium collaborations with UCLA and MD Anderson under NIH programs, and outreach for collaborations and strategic partnerships at scientific conferences.
Patients and clinicians involved in cancer screening and surveillance, including at-risk populations for hepatocellular carcinoma and patients requiring MRD or recurrence monitoring; and other diagnostic companies that use the EarlyDx-Cloud bioinformatics platform to run liquid biopsy tests.
Geography
Operations are tied to California, where the laboratory holds a State of California clinical laboratory license; academic affiliations of the founding team are with UCLA and Stanford University, and research collaborations include UCLA and MD Anderson.
History
The company's publicly documented milestones begin with a September 2022 Nature Communications publication of its cfDNA methylome cancer detection technology and an NIH SBIR Phase II grant for validation in liver and lung cancer. In 2023 it published a deep-learning cfDNA tissue deconvolution method in PNAS, won an NIH SBIR Phase II contract for a cloud-based liquid biopsy and radiomics platform, and received an NIH U01 grant with UCLA and MD Anderson, joining the NIH Liquid Biopsy Consortium. Regulatory and laboratory infrastructure followed with CLIA certification and California licensure (December 2024), a CPT PLA code for MethylScan HCC (April 2025) and CAP accreditation (October 2025). Validation data were presented at AASLD's The Liver Meeting 2025 and published in PNAS (May 2026) and Hepatology Communications (July 2026).
Risks & controversies
In April 2026 the company issued a fraud alert stating that fraudulent recruiting emails were impersonating EarlyDx from domains other than its official earlydx.com domain, and advised recipients not to send personal information.
Compiled by commissioned research from 7 cited public sources — announcements, filings, and press listed under research sources below.
Key figures
latest reportedCompany-reported or press-reported figures, each dated to when it was claimed — not independently audited.
Competitors · 7
by search overlap
Companies competing with Earlydx for the same Google search keywords, organic and paid, via search-intersection analysis.
Non-dilutive funding · 4 SBIR/STTR awards
Federal grants — no equity taken| Agency | Phase | Year | Amount |
|---|---|---|---|
| National Institutes of Health (NIH)National Institutes of Health | Phase II | 2023 | $2M |
| National Institutes of Health (NIH)National Institutes of Health | Phase II | 2022 | $2M |
| National Institutes of Health (NIH)National Institutes of Health | Phase I | 2021 | $395.9K |
| National Institutes of Health (NIH)National Institutes of Health | Phase I | 2020 | $351.6K |
Source: SBIR.gov award data (U.S. Small Business Administration). SBIR/STTR awards are competitive federal R&D grants and contracts — non-dilutive capital alongside any venture rounds above.
Timeline · 13
launches, deals, and filingsClinical validation results for MethylScan HCC in hepatocellular carcinoma surveillance were published in Hepatology Communications under the title "Methylation Plus Alpha-Fetoprotein Blood Test for Early Detection of HCC in At-Risk Populations," reporting 73% sensitivity at 92% specificity for early-stage HCC within Milan criteria.
A peer-reviewed study published in the Proceedings of the National Academy of Sciences demonstrated that MethylScan can detect multiple cancers, liver diseases and organ abnormalities from a single blood sample.
EarlyDx exhibited at the AACR 2026 annual meeting and invited collaboration and strategic partnership discussions.
The company warned that fraudulent recruiting emails were impersonating EarlyDx from unauthorized domains and advised against sharing personal information.
New data on EarlyDx's methylation-based liquid biopsy platform for early hepatocellular carcinoma detection were presented in a late-breaking oral presentation by Dr. Neehar Parikh, covering validation of a blood-based assay combining DNA methylation and AFP for HCC surveillance.
EarlyDx's laboratory received accreditation from the College of American Pathologists (CAP #9954593).
The American Medical Association published a CPT Proprietary Laboratory Analysis (PLA) code for MethylScan HCC on April 1, 2025.
EarlyDx's laboratory became certified under the Clinical Laboratory Improvement Amendments (CLIA) and licensed by the State of California.
Co-founder Jasmine Zhou received an Eminent Scholar Award from the International Association for Intelligent Biology and Medicine in recognition of research innovation.
In collaboration with UCLA and MD Anderson, EarlyDx was awarded an NIH U01 grant on multi-cancer early detection using cell-free DNA methylome analysis, and joined the NIH Liquid Biopsy Consortium.
EarlyDx received an NIH SBIR Phase II contract to build a cloud-based liquid biopsy and radiomics platform for early cancer detection.
The company's technology for using the cfDNA methylome to detect cancer was published in Nature Communications and recognized as one of the journal's "Top 25 Health Sciences Articles of 2022".
EarlyDx was awarded an NIH SBIR Phase II grant to validate its cell-free DNA methylome technology for the early detection of liver and lung cancer.
Dated company events from announcements, filings, and press; legal rows summarize public dockets and regulator releases.
▸Research sources · 7
primary sources listed
- Earlydxearlydx.com · web
7 public sources were cited for this profile; the first-party ones are listed here.
Frequently asked questions
- What does Earlydx do?
- EarlyDiagnostics (EarlyDx) develops methylation-based cell-free DNA blood tests and bioinformatics software for early cancer detection.
- Who founded Earlydx?
- Earlydx was founded by Jasmine Zhou, Wing Hung Wong, Peter Li.
- Who are Earlydx's investors?
- Earlydx's investors include Alpha Edison.