ClearNote Health

What ClearNote Health does

ClearNote Health is a San Diego-based molecular diagnostics company founded in 2016 (originally as Bluestar Genomics, rebranded in 2022) that develops non-invasive, blood-based cancer detection tests built on a proprietary 5-hydroxymethylcytosine (5hmC) epigenomic platform. The company's core technology, branded as the Virtuoso Epigenomics Platform, uses a patented 5hmC enrichment workflow combined with whole-genome sequencing and machine learning to analyze cell-free DNA (cfDNA) in blood samples. ClearNote's commercial product suite — the Avantect Pancreatic Cancer Test, Avantect Ovarian Cancer Test, and Avantect Multi-Cancer Detection (MCD) Test — are laboratory-developed tests (LDTs) run in the company's CLIA-certified, CAP-accredited, NYSDOH-approved San Diego laboratory, targeting high-risk populations such as patients newly diagnosed with type 2 diabetes and those with genetic predispositions. The enhanced Avantect Pancreatic Cancer Test, launched in February 2026, delivers 82.6% sensitivity and 97.5% specificity with greater than 76% Stage I-II sensitivity.

ClearNote operates a hybrid business model across two revenue streams. First, clinical diagnostic testing via physician-ordered LDTs reimbursed by CMS at $1,160 per test for both the pancreatic and ovarian indications, with CPT codes established (including PLA code 0507U for the ovarian test) and an international laboratory partnership network distributing tests across 70 countries. Second, biopharma services through the Virtuoso platform, sold directly to pharmaceutical and biotech partners for drug discovery, therapy response monitoring, patient stratification, and clinical trial support — anchored by named collaborations with Bayer (prostate cancer), Novartis (radioligand therapy biomarkers), and a pharmaceutical services partnership with Personalis.

The company has secured regulatory and clinical-validation milestones that materially de-risk the commercial thesis: FDA Breakthrough Device Designation (2021), NYSDOH approval, UKCA marking across all three Avantect tests (2025), CE Mark for the Avantect Collection Kit, and selection as one of only two technologies for the U.S. National Cancer Institute's Vanguard Multicancer Detection Study (enrolling up to 24,000 people). ClearNote has raised more than $185 million in cumulative funding across multiple rounds, most recently a $52 million Series D closed on May 27, 2026, led by founding investor Mattias Westman. The leadership team includes executives drawn from Roche, Eli Lilly, Grail, Foundation Medicine, Illumina, BD, and Hologic, with scientific advisors including Stanford's Stephen Quake (the platform's originator and company co-founder) and UCSF's Alan Ashworth.

Name

ClearNote Health

Legal name

ClearNote Health

Website

https://clearnotehealth.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

ClearNote Health is a San Diego-based molecular diagnostics company that develops non-invasive blood-based cancer detection tests using a proprietary 5-hydroxymethylcytosine (5hmC) epigenomic platform, serving high-risk patients and biopharma partners across 70 countries.

Ownership category

akta.pro rank

Product category

Molecular Cancer Diagnostics

NAICS

Medical Laboratories (621511), In-Vitro Diagnostic Substance Manufacturing (325413), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Liquid Biopsy Biomarkers (ctDNA/ctRNA/CTCs/exosomes) (HLAAAMAH)

akta.pro secondary industries

Liquid Biopsy & Minimal Residual Disease (MRD) Precision Testing (HLAAANAG), Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

Keywords

• Epigenomic diagnostics
• Early cancer detection
• Liquid biopsy testing
• 5hmC biomarker platform
• Biopharma epigenomics services

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Infrastructure, Operations, Marketing or Sales

Revenue model

1. Clinical Diagnostic Testing (Avantect Tests): Laboratory-developed tests (LDTs) including Avantect Pancreatic Cancer Test, Avantect Ovarian Cancer Test, and Avantect Multi-Cancer Detection Test. Performed in ClearNote Health's CLIA-certified, CAP-accredited laboratory. Tests are physician-ordered, with CMS reimbursement at $1,160 per test for both pancreatic and ovarian tests.
2. Biopharma Services (Virtuoso Platform): Virtuoso epigenomics platform offered to biopharma and academic scientists for drug discovery and development. Provides insights into therapy response and resistance, patient selection for clinical trials, and therapeutic outcome monitoring. Includes pharmaceutical services partnership with Personalis.
3. International Distribution Licensing: Distribution agreements in 70 countries through laboratory partnership network for tests outside the U.S. Exclusive licensing agreement with BCAL Diagnostics for distribution in Australia and New Zealand.

Pricing tiers

Go-to-market motion3 records

Distribution channels5 records

Marketing channels7 records

Core offering

ClearNote Health develops and commercializes non-invasive blood-based cancer diagnostic tests built on a proprietary 5-hydroxymethylcytosine (5hmC) epigenomics platform. Its core commercial offerings are the Avantect Pancreatic Cancer Test, Avantect Ovarian Cancer Test, and Avantect Multi-Cancer Detection Test — laboratory-developed tests performed in the company's CLIA-certified laboratory — along with the Virtuoso Epigenomics Platform, which is licensed to biopharma partners for drug discovery and development.

Product overview

ClearNote Health offers a portfolio structured around a core platform plus a suite of blood-based diagnostic tests. The Virtuoso™ Epigenomics Platform is the patented technology backbone that powers the company's diagnostics and is also sold separately as a research-use-only biopharma tool for drug discovery and therapy response monitoring. Built on the Virtuoso platform, the Avantect® suite of early cancer detection tests includes the Avantect Pancreatic Cancer Test, the Avantect Ovarian Cancer Test, and the Avantect Multi-Cancer Detection (MCD) Test, all of which are laboratory-developed tests performed in ClearNote Health's CLIA-certified, CAP-accredited laboratory using cfDNA, 5hmC epigenomic profiling, and machine learning to detect cancer signals from a standard blood draw.

Differentiator

Problem solved

Functional benefit

Brands

• Avantect: Suite of early cancer detection blood tests developed using the Virtuoso epigenomics platform; includes the Avantect Pancreatic Cancer Test, Avantect Ovarian Cancer Test, Avantect Multi-Cancer Detection (MCD) Test, and Avantect Collection Kit.
• Virtuoso

Products and services

• Avantect Pancreatic Cancer Test Cell-free DNA-based blood test using a 5hmC epigenomic and multiomic approach with machine learning to aid earlier diagnosis of pancreatic cancer in patients at elevated risk, including those aged 50+ newly diagnosed with type 2 diabetes, those with genetic predisposition, and those with family history. Performed in ClearNote Health's CLIA-certified, CAP-accredited laboratory in San Diego.
• Avantect Ovarian Cancer Test Cell-free DNA-based blood test designed to aid earlier diagnosis of ovarian cancer in women at high risk, including those with BRCA1/BRCA2 mutations, Lynch syndrome, or a first-degree family member with ovarian cancer. Uses the Virtuoso epigenomics platform to detect abnormal signals associated with ovarian cancer in cfDNA.
• Avantect Multi-Cancer Detection (MCD) Test Blood test designed to screen for several types of cancer simultaneously in asymptomatic, generally healthy persons. Analyzes 5hmC epigenomic biomarkers and genomic features in circulating cell-free DNA to detect cancer early and identify likely tissue of origin. One of only two assays selected for the NCI Vanguard Study.
• Virtuoso Epigenomics Platform Patented research-use-only (RUO) epigenomics platform that provides insights into active biological processes using whole-genome 5hmC profiling combined with machine learning. Sold to biopharma and academic scientists for drug discovery and development, including therapy response and resistance monitoring, patient selection for clinical trials, and therapeutic outcome assessment.

Quantifiable outcome

• 82.6% overall sensitivity and 97.5% specificity for Avantect Pancreatic Cancer Test
• +5 more outcomes

Named customers6 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

AI capability5 records

Feature6 records

Partnerships

13 partnerships are on record, tiered major, minor and flagship.

• ClaritevmajorChannel Partner/ Reseller/ Distributor · 1 March 2025ClearNote Health's Avantect Pancreatic Cancer Test now available to health plan members accessing Claritev's National PPO Networks (March 2025).
• NovartismajorStrategic or Co-development Partner · 1 January 2024Virtuoso epigenomic platform showed potential predictive biomarkers for radioligand therapy in pancreatic neuroendocrine tumors in collaboration with Novartis. Findings were presented at the ENETS conference in 2024.
• PersonalismajorStrategic or Co-development Partner · 1 January 2024ClearNote and Personalis partnered in 2024 to expand pharmaceutical services with the Virtuoso Epigenomic Platform.
• BayermajorStrategic or Co-development Partner · 1 January 2023Collaboration announced in 2023 to investigate drug treatment response by liquid biopsy in prostate cancer using ClearNote Health's epigenomic platform. Bayer is a major pharmaceutical partner for biopharma services.
• Quest DiagnosticsmajorChannel Partner/ Reseller/ Distributor · 1 January 2023Phlebotomy agreement announced in 2023 with Quest Diagnostics to facilitate blood draw services for Avantect tests.
• Pancreatic Cancer Early Detection (PRECEDE) ConsortiummajorStrategic or Co-development Partner · 1 January 2023ClearNote Health joined the Pancreatic Cancer Early Detection (PRECEDE) Consortium in 2023 as a new partnership to reduce cancer mortality. International multi-center effort focused on advancing earlier diagnosis and risk-stratified screening for people with familial or genetic risk for pancreatic cancer.
• BCAL DiagnosticsminorChannel Partner/ Reseller/ DistributorBCAL Diagnostics holds an exclusive licence with ClearNote Health for distribution of certain blood tests in Australia and New Zealand.
• NHS England / University of SouthamptonmajorStrategic or Co-development PartnerThe Surveillance of pAncreatic health aFter diabEtes Diagnosis (SAFE-D) study led by the NHS in the UK, one of the world's largest projects evaluating pancreatic cancer detection in individuals with new-onset diabetes. Avantect test selected for up to 15,000 patient study.
• Stanford University (Stephen Quake laboratory)flagshipStrategic or Co-development PartnerClearNote Health was founded out of the Stanford laboratory of Steve Quake, D.Phil., to develop non-invasive epigenomic tests to detect cancer through a standard blood draw. The company's patented Virtuoso platform was developed by scientists in the Stephen Quake laboratory at Stanford University.
• University of ChicagominorStrategic or Co-development PartnerBluestar Genomics (now ClearNote Health) and the University of Chicago published the first complete genome map of key biomarkers for detection of cancer and other diseases in 2020.
• Alan Ashworth PhD, FRSminorStrategic or Co-development PartnerScientific advisor to ClearNote Health. President of the Helen Diller Comprehensive Cancer Center, SVP for Cancer Services at UCSF Health, Professor of Hematology Oncology at UCSF. Cancer biomarkers and therapeutics, DNA repair/synthetic lethality expert.
• David A. Diamond, MD, FACROminorStrategic or Co-development PartnerClinical advisor to ClearNote since inception. More than 20 years of clinical oncology experience. Former Chair of the Florida Board of Medicine and Former Chancellor of the American College of Radiation Oncology.
• Tina S. Nova, PhDminorStrategic or Co-development PartnerAdvisor to ClearNote Health. Pioneer in molecular-based diagnostics in oncology. President and CEO of Decipher Biosciences (acquired Veracyte); Former President and CEO of Genoptix (acquired Novartis).

Scale indicators11 records

Recent moves7 records

Expansion highlights7 records

Direct peers

• GRAIL: GRAIL is the leading pure-play multi-cancer early detection (MCED) liquid biopsy company with its Galleri test. Directly comparable to ClearNote's Avantect Multi-Cancer Detection test and recently selected as the other of two NCI Vanguard technologies.
• Guardant Health: Guardant Health is a publicly-traded liquid biopsy company offering Guardant360 (FDA-approved CDx) and Guardant Shield. Comparable as a cfDNA-based oncology diagnostics company using ML on sequencing data, with established commercial and payer footprint ClearNote is working to replicate.
• Exact Sciences: Exact Sciences (Cologuard) is the dominant non-invasive cancer screening company with FDA-approved tests across colorectal and multi-cancer. Comparable in commercial-stage cancer screening via blood/stool assays with established reimbursement and payer contracts.
• Freenome: Freenome is an emerging-stage multiomics liquid biopsy company developing blood-based early cancer detection tests (e.g., colorectal). Comparable as a similarly-stage ML-driven cfDNA/omics cancer detection peer pursuing the same reimbursement and clinical adoption pathway.
• Personalis: Personalis is a cancer genomics company with both biopharma services (like ClearNote's Virtuoso) and a liquid biopsy MRD test (NeXT Personal). Both a strategic partner to ClearNote and a comparable competitor in cfDNA-based oncology testing and pharma services.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/clearnotehealth
• Xx.com/bluestargenomic

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds2 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about ClearNote Health