ClearNote Health Fortifies Leadership to Push Cancer Tests to Market

SAN DIEGO – March 18, 2026 – In a strategic move signaling an aggressive push to commercialize its novel cancer-screening technology, ClearNote Health has announced a significant expansion of its executive team. The company, which specializes in early cancer detection through blood tests, has appointed four seasoned industry veterans, most notably tapping Dr. Jeffrey Venstrom, former Chief Medical Officer of Grail and a global diagnostics head at Eli Lilly, as its new Chief Medical Officer.

The appointments come at a critical juncture for ClearNote and the burgeoning liquid biopsy market. With its AI-driven epigenomic platform, the San Diego-based company is racing against well-funded competitors to establish its technology as a new standard of care for identifying some of the deadliest cancers at their earliest, most treatable stages.

“We’re building a leadership team with the experience and vision required to transform early cancer detection at a global scale,” said Dave Mullarkey, CEO of ClearNote Health, in a statement. “Their leadership will help accelerate adoption of our technology, expand our clinical reach, and give more patients the opportunity to detect cancer earlier, when treatment options and outcomes are greatest.”

A Clinical and Regulatory Power Play

The recruitment of Dr. Venstrom is a major coup and a clear indicator of ClearNote's strategy. A physician-scientist with deep roots in both academic medicine and global biopharma, his resume reads like a who's who of oncology innovation. Before his time at Eli Lilly and Grail—a direct competitor in the multi-cancer early detection space—Dr. Venstrom spent eight years at Roche / Genentech, where he led clinical development and medical affairs at its subsidiary Foundation Medicine. His experience is critical for a company seeking to prove the clinical utility of its tests and navigate the complex regulatory maze.

“Early detection of cancer for high-risk patients represents one of the largest unmet needs in healthcare,” Dr. Venstrom stated. “Due to their remarkable sensitivity and specificity, ClearNote Health’s blood-based tests have the potential to fundamentally shift oncology from late-stage intervention to proactive early detection.”

His primary task will be to lead the generation of rigorous clinical evidence required to win over clinicians, health systems, and regulators. This challenge is amplified by the promotion of Irene Hsieh to Vice President of Regulatory Affairs and Quality Assurance. With over 17 years of experience at firms like Thermo Fisher Scientific and Abbott, Ms. Hsieh is tasked with guiding ClearNote’s platform through discussions with the U.S. Food and Drug Administration (FDA) and other global bodies. The path to approval for such novel diagnostics is arduous, requiring robust data to demonstrate both analytical validity and clinical actionability, a hurdle that many diagnostics companies have struggled to overcome.

Targeting a Crowded Global Market

While the science and regulatory hurdles are formidable, the commercial challenge is equally daunting. The global liquid biopsy market is projected to skyrocket from roughly $6 billion in 2024 to over $20 billion by 2034. To capture a piece of this lucrative pie, ClearNote has brought on Daniel Black as General Manager of International Markets and Jeremy Bennett as Head of Marketing.

Dr. Black, with a 20-year history at industry giants like Centogene and Roche Diagnostics, is charged with crafting the global go-to-market strategy. Mr. Bennett, formerly the VP of Marketing at AI breast health leader iCAD and a 16-year veteran of Myriad Genetics, will lead brand strategy and provider engagement.

Their combined expertise will be crucial as ClearNote goes head-to-head with established giants. Guardant Health, which recently secured the first-ever FDA approval for a blood-based colorectal cancer screening test, and Grail, now part of Illumina, whose Galleri multi-cancer test is already commercially available as a laboratory-developed test (LDT), represent the most immediate competition. Both companies have significant market presence and deep pockets. The hiring of executives with direct experience at these and other major diagnostic firms underscores ClearNote's ambition to compete on a global scale.

The Science of Early Detection

At the heart of ClearNote Health’s strategy is its proprietary Virtuoso™ epigenomics platform. Developed by scientists at Stanford University, the technology moves beyond simply looking for fragments of tumor DNA. Instead, it analyzes patterns of 5-hydroxymethylcytosine (5hmC), an epigenetic marker on DNA that reflects active gene expression. By using artificial intelligence to compare these patterns in a patient's blood sample to known patterns from cancerous and healthy cells, the platform aims to detect the biological "signal" of cancer.

This multi-omic approach has already yielded promising results. The company’s Avantect® Pancreatic Cancer Test, which has received an FDA Breakthrough Device designation, demonstrated a high specificity of 96.9% and a 68.3% sensitivity for detecting early-stage (Stage I/II) cancer in a case-control study of over 2,150 patients. This is particularly significant for a disease like pancreatic cancer, which is often diagnosed too late for effective intervention.

The company has also developed tests for ovarian cancer and a multi-cancer panel, leveraging a library of data from over 50,000 assays to refine its algorithms. However, it is important to note that the Avantect tests have not yet been cleared or approved by the FDA and are currently used for high-risk patient populations.

The Ultimate Test: The NCI Vanguard Study

Perhaps the most significant validation of ClearNote Health's potential comes from its selection for a landmark government study. The company's multi-cancer detection test is one of just two blood-based technologies chosen for the National Cancer Institute’s (NCI) Vanguard Study. The other test selected is the Shield™ test from chief competitor Guardant Health.

The Vanguard Study is a massive undertaking, designed to enroll up to 24,000 people to assess the feasibility of using these tests in a large, diverse population. It is not designed to prove the tests save lives—that would require an even larger, longer randomized controlled trial—but it is a critical stepping stone. The NCI's goal is to determine if such a large-scale trial is even possible and to gather preliminary data on test performance and the patient experience.

For ClearNote Health, inclusion in this prestigious study provides an unparalleled opportunity to generate high-quality data and validate its technology on a national stage. The results, expected within three to four years, will heavily influence the future of not only ClearNote's platform but the entire field of blood-based cancer screening. With a newly fortified leadership team in place, the company is now positioned to execute on its clinical and commercial strategy while its technology undergoes one of its most rigorous evaluations to date.