The Best Way to Slash Cancer Mortality Is Through Early Detection. Cell-Free DNA Epigenomics Could Be the Answer.

“If only we’d caught it sooner.” That phrase echoes through the halls of cancer centers and haunts the homes of hundreds of thousands of people diagnosed with advanced-stage cancer every year.

I’ve said it to myself many times. My father was diagnosed with metastatic stage 4 prostate cancer. After tremendous suffering, he passed away within a year of his diagnosis. The signs and symptoms had been there for years, but nobody had realized what they meant. If only we’d caught it sooner.

The path to improving cancer outcomes — not by weeks or months but by years or decades — begins with early detection. When cancer is caught early, survival rates can be excellent. But the longer the cancer has to grow and spread undetected, the fewer treatment options there are when it is finally diagnosed. Pancreatic and ovarian cancers are among the deadliest cancers, in large part because there are no effective, easily accessible tools for early detection. When those cancers are caught very early, surgical resection may be possible and survival rates are at least 10 times higher than they are for the same cancers detected much later.

That’s why I have spent the last three years leading a company that has developed novel liquid biopsy tests specifically for pancreatic and ovarian cancer. At ClearNote Health, we are dedicated to enabling early detection for some of the deadliest cancers. We want to upend the way people think about cancer: instead of waiting for the cancer to spread and relying upon drugs to hopefully extend the lives of very ill patients by a few months, let’s focus more energy on early detection so patients have far more treatment options and even the chance for full recovery.

ClearNote Health is built on an innovative approach that began in the Stanford University lab of Dr. Steve Quake, where scientists first saw the potential for analyzing epigenetic patterns in cell-free DNA released from tumors into the bloodstream. That breakthrough led to the vision of early cancer detection based on noninvasive testing that we have worked so hard to achieve, with incredibly promising results.

Today, we announced some important new results across multiple cancers. A team of scientists at the National Cancer Institute spent two and a half years evaluating early cancer detection technologies from around the world. This was the most comprehensive, methodical, and objective assessment of these tools that has ever been seen. After benchmarking nearly 20 different tests, the scientists chose ClearNote Health’s Avantect technology as one of the two best performers. This is very significant external validation of the biomarkers we’re looking at and the products that we have. If you’ve been trying to figure out what type of liquid biopsy technologies and biomarkers are among the most effective for early cancer detection, the NCI team has done much of this work and concluded that they are in our test.

I am so proud that our cell-free DNA, epigenomic-based tests have been demonstrated as in the upper echelon of early detection tools. This version of our test, which is capable of detecting multiple types of cancer from a single sample and identifying the tissue of tumor origin, will now be used in the NCI’s Vanguard Study on Multi-Cancer Detection, run by the Cancer Screening Research Network through eight geographically diverse clinical trial hubs. These sites will enroll up to 24,000 total participants and launch a large, randomized feasibility study on multi-cancer detection.?

We are honored to be selected for this important study, and meanwhile we’ll continue advancing our two purpose-built tests for pancreatic and ovarian cancers. Both tests have achieved validation and are now in larger studies designed to demonstrate broader clinical validity and utility. We are also using the underlying epigenomic profiling technology to support our biopharma partners with treatment monitoring, patient selection, biomarker discovery, and more.?

For me, joining ClearNote Health as its first commercial CEO in 2022 felt like the perfect opportunity to weave together threads from my professional career and personal life. In a previous role, I worked to launch an innovative cell-free DNA test for prenatal testing, where it has now become the standard of care. More recently, I led a DNA sequencing instrument company in a role that allowed me to go deeper into the science for clinical research and applications. On a personal level, having both of my parents suffer from cancer and ultimately pass away gave me a mission to take those career experiences and build on them to make a difference for other people facing cancer in the future.?

Just about everyone at ClearNote Health has their own personal story of how cancer has affected their lives. Together, we are a highly motivated team determined to take technological breakthroughs and turn them into practical tests and products that will allow healthcare providers to deliver better outcomes to patients. We are all on a mission to save lives for people with cancer, and the single best way to do that is through early detection.?

I’ll be attending the J.P. Morgan Healthcare Conference next week. If you’re interested in learning more about multi-cancer early detection, our tests for pancreatic and ovarian cancers, or our biopharma partnership business, don’t hesitate to reach out.

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