On January 20, 2022 Bluestar Genomics, Inc., an early cancer detection company leading the development and commercialization of next-generation liquid biopsy approaches initially focused on non-invasive detection of high-mortality cancers, reported positive performance evaluation study results for its pancreatic cancer test (Press release, Bluestar Genomics, JAN 20, 2022, View Source [SID1234605671]). These data confirm that its pancreatic cancer test detects the disease with 55.2% sensitivity and 98.4% specificity in patients with and without diabetes. The study results will be presented on January 21 at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers (ASCO GI) Symposium in San Francisco.

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The new results underscore the importance of earlier pancreatic cancer detection when effective therapies are still possible. Research shows that one in four people diagnosed with pancreatic cancer were first diagnosed with Type 2 diabetes. For the hundreds of thousands of people with new-onset Type 2 diabetes who are potentially at risk for pancreatic cancer, early pancreatic cancer detection could help prevent a late-stage cancer diagnosis.

"Building on the previous data that led to FDA’s breakthrough device designation for our pancreatic cancer test, we continue to focus on addressing the deadliest of cancers with early detection," said Samuel Levy, Ph.D., chief scientific officer at Bluestar Genomics. "Now, with more than a dozen scientific publications and presentations, the precision of our proprietary 5-hydroxymethylcytosine-based platform is evident."

Bluestar Genomics’ pancreatic cancer test uses a standard blood draw to assess whether an individual has an abnormal epigenomic signal associated with pancreatic cancer. With no existing clinical standard of care for screening for pancreatic cancer, Bluestar Genomics’ groundbreaking epigenomics technology platform employs state-of-the-art machine learning coupled with the DNA-based 5-hydroxymethylcytosine (5hmC) biomarker, as a novel method to detect cancer earlier.

The study, which included 1,433 men and women between 45- and 75-years old from 146 sites in the U.S., evaluated the performance of the test in detecting pancreatic cancer signal in new-onset diabetes using Bluestar Genomics’ proprietary epigenomic platform technology based on plasma-derived cell-Free DNA 5-hmC signatures.

"Pancreatic cancer accounts for only three percent of new cancer cases, yet it is the third leading cause of cancer-related death in the United States," said Kelly Bethel, M.D., practicing pathologist at a major medical center in San Diego, and chief medical officer at Bluestar Genomics. "With pancreatic cancer having the poorest overall survival of all the major cancer types, it is imperative that we change the paradigm of late diagnosis depriving patients of potentially curative treatments."

With the prevalence of diabetes increasing worldwide, it is estimated that by 2025, more than 37 million patients will have been diagnosed with diabetes in the U.S. This growing prevalence highlights the need for a non-invasive early pancreatic cancer detection approach.