New clarity in early cancer detection enabling healthier lives.
ClearNote Health is a cancer detection company focused on enabling people at risk for high-mortality cancers to live longer, healthier lives. Utilizing a standard blood draw, our proprietary epigenomic platform combines biology and artificial intelligence to provide a more comprehensive view of biology to identify DNA-based changes in biology as cancer develops.
With our focus on high-mortality cancer detection in high-risk patients, ClearNote Health is changing the patient care paradigm by offering clinicians and their patients a better way to identify cancers at a more treatable stage.
Our mission is to identify people with cancer earlier to enhance their treatment options and enable them to live longer, healthier lives.
Inspired by patients and the discovery of a unique 5-hydroxymethylcytosine (5hmC) biomarker, 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 cancer detection, with patient needs at the core of everything we pursue.
- ClearNote Health receives final Clinical Lab Fee Schedule payment determination from the Centers for Medicare and Medicaid Services for Avantect test of $1,160 per test
- 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
- 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.
- 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.
- 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.
- Bluestar Genomics presented new data demonstrating feasibility of a novel blood test for earlier detection and classification of multiple cancers.
- Laboratory opened at the company headquarters in San Diego, California.
- Several development studies began through multiple collaborations.
- 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.
- 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.