Latest news with #DaveMullarkey
Business Wire
09-07-2025
- Business
- Business Wire
ClearNote Health Receives First In Vitro Diagnostic Approval for its Avantect ® Pancreatic Cancer Test
SAN DIEGO--(BUSINESS WIRE)-- ClearNote Health, a company focused on improving early detection for some of the deadliest cancers, today announced that it has received UK Conformity Assessed (UKCA) marking for its Avantect ® Pancreatic Cancer Test. The UKCA mark, established as part of the United Kingdom's independent product safety regulatory framework following its departure from the European Union, signifies compliance with UK medical device regulations and paves the way for commercial availability in the UK market. 'Achieving UKCA marking for the Avantect Pancreatic Cancer Test is a significant milestone as the first in vitro diagnostic approval for ClearNote Health,' said Dave Mullarkey, CEO at ClearNote Health. The Avantect Pancreatic Cancer Test is an innovative blood test designed to detect pancreatic cancer at its earliest and most treatable stages. The test analyzes epigenomic and genomic data generated by sequencing circulating, cell-free DNA collected from a simple blood draw. It is designed to be part of a diagnostic evaluation, interpreted in the context of other clinical findings for the diagnosis of pancreatic cancer. As many as 15,000 patients in the UK recently gained access to the Avantect Pancreatic Cancer Test through the Surveillance of pAncreatic health aFter diabEtes Diagnosis (SAFE-D) study. This landmark clinical trial is sponsored by the University Hospital Southampton, NHS Foundation Trust, and is being conducted by researchers at the Southampton Clinical Trials Unit at the University of Southampton. The UKCA mark paves the way for ClearNote Health and its distributors to offer the Avantect Pancreatic Cancer Test to UK patients who are not participating in the SAFE-D study. 'Achieving UKCA marking for the Avantect Pancreatic Cancer Test is a significant milestone as the first in vitro diagnostic approval for ClearNote Health,' said Dave Mullarkey, CEO at ClearNote Health. 'It represents the company's transition from laboratory-developed tests to formally regulated commercial diagnostics, reinforcing our commitment to quality, clinical rigor, and global regulatory standards. This approval lays the foundation for additional international expansion and broader patient access.' For more information on the Avantect Pancreatic Cancer Test, please visit About ClearNote Health ClearNote Health is a privately held company dedicated to improving early detection and monitoring for some of the deadliest forms of cancer. Developed by scientists in the Stephen Quake laboratory at Stanford University, the company's patented core Virtuoso™ epigenomics platform builds on the latest advances in artificial intelligence and bioinformatics to measure active biological differences between cancer and healthy cells in a blood sample. The company's highly sensitive, noninvasive Avantect ® Pancreatic and Ovarian diagnostic tests are designed to identify cancers in high-risk patient populations far earlier than conventional approaches, when patients are most likely to benefit from treatment. ClearNote Health's headquarters and CLIA-certified, CAP-accredited, and New York State Department of Health-permitted laboratory are located in San Diego. For more information, visit or follow the company on Bluesky or LinkedIn.
Yahoo
12-03-2025
- Business
- Yahoo
ClearNote Health's Avantect® Pancreatic Cancer Test Now Available to Health Plan Members Accessing Claritev's National PPO Networks
Latest agreement expands access to the PHCS and MultiPlan Networks SAN DIEGO, March 12, 2025--(BUSINESS WIRE)--ClearNote Health, a company focused on improving early detection for some of the deadliest cancers, today announced an agreement with Claritev, Inc. ("Claritev") (NYSE: CTEV), previously MultiPlan, Inc. (NYSE: MPLN), a technology and data insights company focused on making healthcare more affordable, transparent, and fair for all. As part of the agreement, ClearNote Health's Avantect® Pancreatic Cancer Test will now be available to health plan members accessing Claritev's national PHCS and MultiPlan Networks. While early detection has vastly improved survival rates for many types of cancer, pancreatic cancer is often diagnosed at an advanced metastatic stage when patients have a five-year survival rate as low as 3%.1 The ClearNote Avantect test is an innovative DNA-based blood test that uses key epigenomic and genomic signals coupled with machine learning to detect the earliest indicators of pancreatic cancer when patients are most likely to benefit from treatment. The Avantect Pancreatic Cancer Test was designed for patients at high risk of pancreatic cancer, including those newly diagnosed with type 2 diabetes who are at least 50 years old, as well as those with a relevant family history and/or a genetic predisposition. It detects pancreatic cancer by profiling the epigenomic biomarker 5-hydroxymethylcytosine (5hmC) in cell-free DNA and uses advanced AI algorithms to combine that data with other genomic information. This 5hmC-based approach provides a more comprehensive view of the active biological changes related to tumor development, allowing clinicians to identify cancer far earlier than with conventional methods. "Participation in Claritev's PHCS and MultiPlan Networks is another critical commercial milestone that will make it easier for health plan members accessing Claritev's provider networks to use our innovative early cancer detection technology," said Dave Mullarkey, CEO at ClearNote Health. "We look forward to working with Claritev to enable early detection of pancreatic cancer in high-risk patients so they can live longer, healthier lives." For more information on the Avantect cancer tests, please visit About ClearNote Health ClearNote Health is a privately held company dedicated to improving early detection and monitoring for some of the deadliest forms of cancer. Developed by scientists in the Stephen Quake laboratory at Stanford University, the company's patented core Virtuoso™ epigenomics platform builds on the latest advances in artificial intelligence and bioinformatics to measure active biological differences between cancer and healthy cells in a blood sample. Its highly sensitive, noninvasive Avantect® pancreatic and ovarian diagnostic tests are designed to identify cancers in high-risk patient populations far earlier than conventional approaches, when patients are most likely to benefit from treatment. ClearNote Health's headquarters and CLIA-certified, CAP-accredited laboratory are located in San Diego. For more information, visit or follow the company on X or LinkedIn. About Claritev Claritev is a healthcare technology, data and insights company focused on delivering affordability, transparency and quality to the U.S. healthcare system. Led by a team of deeply experienced associates, data scientists and innovators, Claritev provides cutting-edge solutions and services fueled by over 40 years of claims processing data insights. Claritev leverages world-class technology to power a robust enterprise platform that delivers meaningful insights to drive affordability and price transparency, and optimizes networks and benefits design in healthcare. By developing purpose-built solutions that support all key stakeholders — including payors, employers, patients, providers and third parties — Claritev is dedicated to making healthcare more accessible and affordable for all. Claritev serves more than 700 healthcare payors, over 100,000 employers, 60 million consumers and 1.4 million contracted providers. For more information, visit ClearNote Health, the ClearNote Health logo, and Avantect, are registered trademarks of ClearNote Health. References 1. Rawla P, Sunkara T, Gaduputi V. Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 2019 Feb;10(1):10-27. doi: 10.14740/wjon1166. View source version on Contacts Media Contact Andrew Noble415-722-2129andrew@ Sign in to access your portfolio
Associated Press
12-03-2025
- Health
- Associated Press
ClearNote Health's Avantect® Pancreatic Cancer Test Now Available to Health Plan Members Accessing Claritev's National PPO Networks
ClearNote Health, a company focused on improving early detection for some of the deadliest cancers, today announced an agreement with Claritev, Inc. ('Claritev') (NYSE: CTEV), previously MultiPlan, Inc. (NYSE: MPLN), a technology and data insights company focused on making healthcare more affordable, transparent, and fair for all. As part of the agreement, ClearNote Health's Avantect® Pancreatic Cancer Test will now be available to health plan members accessing Claritev's national PHCS and MultiPlan Networks. While early detection has vastly improved survival rates for many types of cancer, pancreatic cancer is often diagnosed at an advanced metastatic stage when patients have a five-year survival rate as low as 3%. 1 The ClearNote Avantect test is an innovative DNA-based blood test that uses key epigenomic and genomic signals coupled with machine learning to detect the earliest indicators of pancreatic cancer when patients are most likely to benefit from treatment. The Avantect Pancreatic Cancer Test was designed for patients at high risk of pancreatic cancer, including those newly diagnosed with type 2 diabetes who are at least 50 years old, as well as those with a relevant family history and/or a genetic predisposition. It detects pancreatic cancer by profiling the epigenomic biomarker 5-hydroxymethylcytosine (5hmC) in cell-free DNA and uses advanced AI algorithms to combine that data with other genomic information. This 5hmC-based approach provides a more comprehensive view of the active biological changes related to tumor development, allowing clinicians to identify cancer far earlier than with conventional methods. 'Participation in Claritev's PHCS and MultiPlan Networks is another critical commercial milestone that will make it easier for health plan members accessing Claritev's provider networks to use our innovative early cancer detection technology,' said Dave Mullarkey, CEO at ClearNote Health. 'We look forward to working with Claritev to enable early detection of pancreatic cancer in high-risk patients so they can live longer, healthier lives.' For more information on the Avantect cancer tests, please visit About ClearNote Health ClearNote Health is a privately held company dedicated to improving early detection and monitoring for some of the deadliest forms of cancer. Developed by scientists in the Stephen Quake laboratory at Stanford University, the company's patented core Virtuoso™ epigenomics platform builds on the latest advances in artificial intelligence and bioinformatics to measure active biological differences between cancer and healthy cells in a blood sample. Its highly sensitive, noninvasive Avantect® pancreatic and ovarian diagnostic tests are designed to identify cancers in high-risk patient populations far earlier than conventional approaches, when patients are most likely to benefit from treatment. ClearNote Health's headquarters and CLIA-certified, CAP-accredited laboratory are located in San Diego. For more information, visit or follow the company on X or LinkedIn. About Claritev Claritev is a healthcare technology, data and insights company focused on delivering affordability, transparency and quality to the U.S. healthcare system. Led by a team of deeply experienced associates, data scientists and innovators, Claritev provides cutting-edge solutions and services fueled by over 40 years of claims processing data insights. Claritev leverages world-class technology to power a robust enterprise platform that delivers meaningful insights to drive affordability and price transparency, and optimizes networks and benefits design in healthcare. By developing purpose-built solutions that support all key stakeholders — including payors, employers, patients, providers and third parties — Claritev is dedicated to making healthcare more accessible and affordable for all. Claritev serves more than 700 healthcare payors, over 100,000 employers, 60 million consumers and 1.4 million contracted providers. For more information, visit 1. Rawla P, Sunkara T, Gaduputi V. Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 2019 Feb;10(1):10-27. doi: 10.14740/wjon1166. Andrew Noble 415-722-2129 [email protected] SOURCE: ClearNote Health Copyright Business Wire 2025. PUB: 03/12/2025 08:03 AM/DISC: 03/12/2025 08:03 AM
Yahoo
18-02-2025
- Health
- Yahoo
ClearNote Health Earns Approval for Avantect® Pancreatic Cancer Test from New York State Department of Health
Physicians in New York can now order the highly sensitive blood test designed to detect pancreatic cancer far earlier than conventional approaches SAN DIEGO, February 18, 2025--(BUSINESS WIRE)--ClearNote Health, a company focused on improving early detection for some of the deadliest cancers, today announced that the New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) has approved its Avantect® Pancreatic Cancer Test. With this approval, clinicians in New York State can now order this highly sensitive blood test, which is designed to detect the biological signals of pancreatic cancer in its earliest stages for patients with known risk factors. "New York State is well known for its rigorous, patient-focused quality standards for laboratory-developed tests. This approval is another critical milestone for ClearNote Health, further validating our ongoing commitment to excellence in our tests and in our clinical laboratory services," said Dave Mullarkey, CEO at ClearNote Health. "We are quickly transforming the patient care paradigm with a proprietary, epigenomics-based approach that allows clinicians to detect pancreatic cancer at a more treatable stage so patients can enjoy longer, healthier lives." While early detection has vastly improved survival rates for other types of cancer, pancreatic cancer is often diagnosed at an advanced metastatic stage when patients have a five-year survival rate as low as 3%.1 The Avantect Pancreatic Cancer Test is for patients at high risk of pancreatic cancer, including those newly diagnosed with type 2 diabetes who are at least 50 years old, as well as those with a family history and/or a genetic predisposition. The test was designed to detect pancreatic cancer in its earliest stages by profiling the epigenomic biomarker 5-hydroxymethylcytosine (5hmC) in cell-free DNA and combining that data with other genomic information. Unlike conventional methods, ClearNote's approach leverages the latest advances in machine learning and bioinformatics to provide a deeper understanding of the underpinnings of cancer development with unprecedented clarity to inform the next steps in a patient care pathway. For more information about the Avantect Pancreatic Cancer Test, please visit The NYSDOH CLEP regulates and oversees laboratories that accept clinical specimens originating in New York State. It seeks to ensure the accuracy and reliability of test results in clinical laboratories located in or accepting specimens from New York State. The ClearNote Health Laboratory now has its NYSDOH permit, as well as its CLIA certification and CAP accreditation. About ClearNote Health ClearNote Health is a privately held company dedicated to improving early detection and monitoring for some of the deadliest forms of cancer. Developed by scientists in the Stephen Quake laboratory at Stanford University, the company's patented core Virtuoso® epigenomics platform builds on the latest advances in artificial intelligence and bioinformatics to measure active biological differences between cancer and healthy cells in a blood sample. The company's highly sensitive, noninvasive Avantect® Pancreatic and Ovarian diagnostic tests are designed to identify cancers in high-risk patient populations far earlier than conventional approaches, when patients are most likely to benefit from treatment. ClearNote Health's headquarters and CLIA-certified, CAP-accredited laboratory are located in San Diego. For more information, visit or follow the company on X or LinkedIn. ClearNote Health, the ClearNote Health logo, Avantect, and Virtuoso are registered trademarks of ClearNote Health. References 1. Rawla P, Sunkara T, Gaduputi V. Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 2019 Feb;10(1):10-27. doi: 10.14740/wjon1166. View source version on Contacts Media Contact Andrew Noble415-722-2129andrew@ Sign in to access your portfolio
