New data show that ClearNote Health’s epigenomic platform provides a novel tissue-free, liquid biopsy-based approach to identify potential predictive biomarker candidates for response to radioligand therapy in patients with pancreatic neuroendocrine tumors
New data show that ClearNote Health’s epigenomic platform provides a novel tissue-free, liquid biopsy-based approach to identify potential predictive biomarker candidates for response to radioligand therapy in patients with pancreatic neuroendocrine tumors

–Data presented at the European Society for Neuroendocrine Tumors 2024–

SAN DIEGO March 26, 2024—(BUSINESS WIRE)–ClearNote® Health, a company on a mission to help people with cancer live longer through earlier detection, today announced the results of a joint study with Novartis and Norwegian Biobank evaluating plasma-based epigenetic biomarkers , associated with response to treatment with Lutathera® ([177Lu]Lu-DOTA-TATE) in patients with pancreatic neuroendocrine tumors.

Presenting at the European Neuroendocrine Tumor Society (ENETS) 2024 conference, Dr. John Sponheim (Rikshospitalet, Oslo University Hospital) revealed new data demonstrating the application of ClearNote Health’s epigenomic technology platform (Virtuoso) in evaluating differences in 5hmC profiles of responders versus short responders before and during Lutathera therapy. Differences in plasma-free DNA (cfDNA) 5hmC profiles following Lutathera administration reveal biological responses consistent with the hypothesized mechanism of action of radioligand therapy. Study Results, Abstract #F23, “5-Hydroxymethylcytosine Profiling of Plasma-Derived Circulating Free DNA in Patients with Pancreatic Neuroendocrine Tumors Treated with [177Lu]Lu-DOTA-TATE,” demonstrated Virtuoso’s ability to provide biological insights and response biomarkers using only plasma.

“Our research collaboration with Novartis demonstrates the power of ClearNote Health’s cutting-edge epigenomic technology in querying predictive biomarkers of response to radioligand therapy from a single blood draw,” said Dave Mularkey, CEO of ClearNote Health. “We are committed to partnering with pharmaceutical and research industry leaders to advance their precision medicine programs and help improve patient outcomes.”

The study used Virtuoso to generate cfDNA 5hmC profiles from plasma samples obtained from patients with pancreatic neuroendocrine tumors who received Lutathera, an FDA-approved radiolabeled somatostatin analog for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Comparison of plasma-derived cfDNA 5hmC profiles revealed differences that distinguished responders from non-responders before and during treatment.

This collaboration underscores ClearNote Health’s commitment to empowering biopharmaceutical innovation in the development of better medicines through cutting-edge molecular diagnostics technologies. For more information about ClearNote Health and its innovative solutions, visit www.clearnotehealth.com.

About ClearNote Health

ClearNote Health is a cancer discovery company focused on enabling people at risk of high mortality cancers to live longer and healthier lives. Using a standard blood draw, the company applies its proprietary epigenomic platform, combining biology and artificial intelligence, to identify DNA-based changes in biology as cancer develops. With leading programs for the non-invasive early detection of pancreatic and ovarian cancer in patients at highest risk for these diseases, ClearNote Health identifies cancers before they progress and when patients are most likely to benefit from treatment. ClearNote Health is headquartered in San Diego, with additional presence in the San Francisco Bay Area and internationally. The company’s CLIA and CAP accredited laboratory is located in San Diego, California. For more information, visit www.clearnotehealth.com or follow the company on LinkedIn. To learn more about the Avantect pancreatic cancer test, visit www.avantect.com.

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Dounia Kristan, Health+Commerce
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