About ClearNote Health

New clarity in early cancer detection enabling healthier lives.

ClearNote Health is a cancer detection company committed to extending and improving the lives of individuals at risk for high-mortality cancer. Using a standard blood draw, our proprietary 5hmC-epigenomic platform integrates advanced biology with artificial intelligence to deliver a more comprehensive view of molecular changes in the body, identifying DNA-based alterations as cancer develops.

We have used this platform to develop Avantect, a suite of early cancer detection tests, and Virtuoso, a powerful tool that enables precision Research and Development of new therapeutics.

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Avantect Test for Pancreatic Cancer

The Avantect Pancreatic Cancer Test is a novel, cell-free DNA-based blood test to aid in earlier diagnosis of patients at high risk for developing pancreatic cancer, offering a greater chance for improved survival.

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Avantect Test for Ovarian Cancer

The Avantect Ovarian Cancer Test is a novel, cell-free DNA-based blood test to aid in earlier diagnosis in women at high risk for developing ovarian cancer, offering a greater chance for improved survival.

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Virtuoso Epigenomics Platform

Virtuoso measures active disease biology from drug discovery through development, including dynamic insights into therapy response and resistance - all through a simple blood draw.

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I am passionate about advancing precision medicine for better patient outcomes.

Gulfem Guler, PhD
Vice President, Translational Research, Head of Biopharma Development
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Translating complex biology and technology into valuable patient-centric products is what excites me the most.

Samuel Levy, PhD Chief Scientific Officer
CSO
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Dave Mullarkey

I am inspired by scaling truly innovative companies centered around the most urgent patient needs. With a laser focus on science and corporate development, companies can thrive while improving patient lives.

Dave Mullarkey
CEO
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Our History

Inspired by patients and the discovery of a unique 5-hydroxymethylcytosine (5hmC) mark, ClearNote 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 earlier than existing methods and when the disease is still treatable. We are proud of the clinical evidence, R&D achievements, and our five-year-long company development as Bluestar Genomics. Now, as a commercial-stage company, ClearNote Health continues to drive innovation in non-invasive liquid biopsy cancer detection, with patient needs at the core of everything we pursue.

2025

  • ClearNote Health Earns Approval for Avantect Pancreatic Cancer Test from New York State Department of Health (NYSDOH)
  • ClearNote Health receives final Clinical Lab Fee Schedule payment determination from the Centers for Medicare and Medicaid Services for Avantect Ovarian test of $1,160 per test

2024

  • Selected by U.S. National Cancer Institute for the Vanguard Multicancer Detection study as one of two, among numerous applicants.
  • ClearNote Health signs three additional international distribution agreements to make. Avantect testing available in over 50 countries. Avantect Ovarian Cancer Test AMA CPT Proprietary Laboratory Analyses (PLA) code 0507U became effective.
    CMS announced that it has proposed preliminary reimbursement rate determination for the Avantect Ovarian Cancer Detection Test
    Cost-Effectiveness for Avantect Pancreatic Cancer Test presented at the ISPOR Europe 2024 Meeting in New Onset Type 2 Diabetes (NOD) population.
  • Avantect Pancreatic Cancer test selected by NHS England for up to 15,000 patient study of detecting latent pancreatic cancer early, in patients recently diagnosed with Type 2 diabetes. Virtuoso epigenomic platform shows potential predictive biomarkers for radioligand therapy in pancreatic neuroendocrine tumors in collaboration with Novartis. Findings were presented at the ENETS conference Presented Avantect ability to detect high-risk pancreatic cysts at  Digestive Disease Week 2024.
  • Virtuoso shows ability to predict immunotherapy treatment response and resistance in non-small cell lunch cancer; data presented at American Association of Cancer Research Analytical Validation of Avantect Pancreatic Cancer shows significant sensitivity with early stage pancreatic cancer detection. Results are published in the Journal of Molecular Diagnostics.
  • ClearNote Health’s Virtuoso platform predicts treatment response and resistance in non-small cell lung cancer patients undergoing anti-PD1 therapy; data presented at AACR ClearNote and Personalis partner to expand pharmaceutical services with Virtuoso Epigenomic Platform.
  • ClearNote Health Makes Avantect Ovarian Cancer Test Commercially Available Avantect Collection Kit receives CE Mark enabling broader global access ClearNote Health receives final Clinical Lab Fee Schedule payment determination from the Centers for Medicare and Medicaid Services for Avantect Pancreatic test of $1,160 per test.

2023

  • ClearNote Health Announces Collaboration with Bayer to Investigate Drug Treatment Response by Liquid Biopsy in Prostate Cancer. 
  • ClearNote Health Joins the Pancreatic Cancer Early Detection (PRECEDE) Consortium in New Partnership to Reduce Cancer Mortality Avantect Pancreatic Cancer Test Receives CPT Code and Preliminary Payment Determination from the Centers for Medicare and Medicaid Services ClearNote Health announces Phlebotomy agreement with Quest Diagnostics.
  • ClearNote Health presents data at AACR Pancreatic in pre-cancerous High-Grade Dysplasia Pivotal Study Validates ClearNote Health’s Avantect Pancreatic Cancer Detection Test Performance Published in the Journal Clinical Gastroenterology and Hepatology ClearNote Health successfully passes New York State Department of Health inspection. 
  • ClearNote Health signs two new international distribution agreements. 
  • ClearNote Health implements 3rd party billing capabilities
  • ClearNote Health Makes Avantect Pancreatic Cancer Test Commercially Available
  • ClearNote Health to Presents at 41st Annual J.P. Morgan Healthcare Conference

2022

  • Bluestar Genomics Rebrands as ClearNote Health. 
  • Bluestar Genomics Secures 1st international distribution agreement. 
  • Bluestar Genomics launches physician experience program to bring its pancreatic cancer detection test into clinical use, based on positive validation study results reported at American Pancreatic Association annual meeting. 
  • Bluestar Genomics receives CAP Accreditation for its clinical laboratory. Large study results reported at AACR Special Conference on Pancreatic Cancer validate 5hmC-based algorithm for early detection of pancreatic cancer. Company’s first oral presentation at ESMO highlights expansion of 5hmC technology platform into tumor tissue analysis. 
  • Data presentation at AGBT Precision Health shows promise of Bluestar Genomics’ technology as ovarian cancer detection tool. Samuel Levy, PhD, named Top 50 influencer in life sciences by the San Diego Business Journal. San Diego lab receives official CLIA license; first clinical sample tested. 
  • Bluestar Genomics presented positive results of its pancreatic cancer test performance evaluation at 2022 ASCO GI Cancers Symposium. 
  • Bluestar Genomics debuted at J.P. Morgan Health Care Conference. 
  • Bluestar Genomics appointed David Mullarkey as Chief Executive Officer. Performance of the company’s pancreatic cancer test published in medRxiv.

2021

  • Analytical performance data for pancreatic cancer signal detection presented at the American Pancreatic Association annual meeting. 
  • Company initiated commercialization efforts with the appointment of Jim Vaughn as Chief Commercial Officer. 
  • Bluestar Genomics raised $70 million in equity funding and added two prominent scientific and clinical advisors: Craig Venter, Ph.D., and Felix Feng, M.D. 
  • The FDA awarded Bluestar Genomics with a Breakthrough Device Designation for a one-of-its-kind assay for patients newly diagnosed with diabetes and at risk for pancreatic cancer.

2020

  • Bluestar Genomics and the University of Chicago published the first complete genome map of key biomarkers for detection of cancer and other diseases. 
  • Nature Communications published a study demonstrating Bluestar Genomics’ epigenomic approach delivered a proof-of-concept for early cancer detection paving the way for next-generation liquid biopsy tests. San Diego-based laboratory became fully automated.

2019

  • Bluestar Genomics presented new data demonstrating feasibility of a novel blood test for earlier detection and classification of multiple cancers.

2018

  • Laboratory opened at the company headquarters in San Diego, California. Several development studies began through multiple collaborations.

2017

  • Samuel Levy, Ph.D., joined the company as Chief Scientific Officer bringing decades of scientific and executive leadership expertise in genomics and molecular diagnostic development.

2016

  • Stephen Quake, D. Phil, and his team discovered the viability of monitoring 5-hydroxymethylcytosine (5hmC) levels in cell-free DNA (cfDNA) by sequencing blood samples from patients with different cancers. 
  • Quake co-founded Bluestar Genomics to develop next-generation liquid biopsy tests to address some of the deadliest cancers by detecting cancer signals earlier than existing methods.

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