ClearNote® Health, a cancer detection company focused on identifying cancer earlier in people at high risk for the deadliest cancers to enable longer lives, today announced it has signed an agreement to partner with the Pancreatic Cancer Early Detection (PRECEDE) Consortium. The PRECEDE Consortium is an international, multi-institutional collaborative group of experts working to improve early detection for those with a heritable risk for pancreatic cancer, or those with pancreatic cysts, through a novel model of collaboration and data sharing.

The PRECEDE Consortium is leading an observational longitudinal prospective cohort study, with serial biosample collection and standard of care imaging obtained every 6-12 months for individuals in predefined high-risk groups. To date, the study has enrolled more than 5,000 participants across 43 sites globally. ClearNote Health’s Avantect™ Pancreatic Cancer Test, currently commercially available for high-risk patients including those recently diagnosed with type 2 diabetes, will be used as a surveillance tool in conjunction with imaging for early cancer detection with the goal of further validating and expanding the use of the molecular test in other high-risk groups.

In 2023, an estimated 64,050 new cases of pancreatic cancer will be diagnosed in the United States, and 50,550 people will die from the disease. Fewer than 20% of patients are candidates for surgery because the cancer has usually spread beyond the pancreas by the time it has been diagnosed. For all stages combined, the five-year relative survival rate for the disease is 12%.¹ The PRECEDE Consortium’s mission is to increase this rate to 50% within the next decade.

“We are very excited to begin this collaboration with ClearNote Health to further validate the efficacy of the Avantect Pancreatic Cancer Test,” said George Zogopoulos, M.D., Ph.D., Associate Professor, McGill University, and one of the PRECEDE principal investigators and members of the PRECEDE executive committee. “ClearNote Health and PRECEDE share a common mission – to increase the survival rate for pancreatic cancer. PRECEDE was created to establish a centralized database of individuals considered to be at high risk for pancreatic cancer who could participate in collaborative studies conducted under the auspices of the PRECEDE Consortium. With over 40 medical institutions worldwide and over 5,100 high-risk study participants, and growing every month, PRECEDE, along with carefully selected partners such as ClearNote Health, is in a unique position to identify ways to detect pancreatic cancer at its earliest, most treatable stages. We are optimistic that this collaboration with ClearNote Health will help lead the way to a 50% survival rate within the next 10 years.”

“Our goal is to help patients detect cancer earlier, especially patients with family history or genetic changes that put them at higher risk for pancreatic cancer, so that they may receive life-saving treatment earlier,” said Samuel Levy, Ph.D., chief scientific officer of ClearNote Health. “By partnering with PRECEDE Consortium, we can provide a unique molecular detection tool that, alongside standard of care imaging, could enable early detection and significantly improve patient survival.”

The Avantect test is a DNA-based blood test created by measuring epigenomic levels of the 5-hydroxymethylcytosine (5hmC) biomarker along with genomic features to assess whether an individual has an abnormal DNA signal associated with early-stage pancreatic cancer or high-grade dysplasia. By using both epigenomic and genomic profiles in patients’ blood, ClearNote Health assembles an informative cancer biomarker set using machine learning algorithms to identify cancer signals through DNA derived from tumor cells via circulating cell-free DNA (cfDNA).

ClearNote Health will join and present at the PRECEDE Consortium’s Annual Meeting in New York City on December 6-7, 2023.

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¹Cancer Facts & Figures 2023. American Cancer Society.

About ClearNote Health

ClearNote Health is a cancer detection company focused on identifying cancer earlier to enable better survival for people at risk for high-mortality cancers. Utilizing 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 lead programs in non-invasive early detection of pancreatic and ovarian cancers in patients at the 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, Calif. For more information, visit www.clearnotehealth.com or follow the company on X or LinkedIn. To learn more about the Avantect Pancreatic Cancer Test, visit the test website.

About the PRECEDE Consortium

The PRECEDE Consortium, formed in 2018, is the largest effort of its kind, using a novel model of data sharing and collaboration among academic medical centers worldwide. Our goal is to increase the survival rate for pancreatic cancer from 12% to 50% within the next 10 years by developing new methods of early detection that will result in potentially lifesaving treatment before the cancer develops or while it is still treatable with surgery. According to the American Cancer Society, it is estimated that about 64,000 people in the U.S. will be diagnosed with pancreatic cancer in 2023. Over 50,000 will die from the disease this year. Pancreatic cancer currently accounts for 3% of all new cancer diagnoses but 7% of all cancer deaths.

As of September 29, 2023, the PRECEDE Consortium includes over 40 academic medical centers from around the globe, and over 5,100 individuals at high risk are enrolled in the study. The vision for PRECEDE came out of a recognition that only by working together could researchers have access to the data needed to develop effective tools for screening and early detection.

For more information, go to precedestudy.org.

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