Multiple sites launch enrollment of patients at up to eight times higher risk for pancreatic cancer – those recently diagnosed with Type 2 diabetes
SAN DIEGO —December 6, 2022 – Bluestar Genomics, Inc., an early cancer detection company leading the development and commercialization of next-generation liquid biopsy tests initially focused on non-invasive detection of high-mortality cancers in high-risk patient populations before symptoms appear, announced the initiation of the New Onset Diabetes Management for Earlier Detection (NODMED) trial, one of the largest clinical studies in pancreatic cancer to date. The trial will use Bluestar Genomics’ proprietary epigenomic methods for detection of the disease.
With research showing that patients recently diagnosed with Type 2 diabetes are almost eight times more likely to develop pancreatic cancer, Bluestar Genomics aims to directly address the unmet need for early disease detection by further validating the utility and accuracy of its pancreatic cancer detection test in high-risk patients. The company’s new DNA-based test uses a standard blood draw to identify pancreatic cancer signal at its earliest stages by measuring levels of the 5-hydroxymethylcytosine (5hmC) in cell free DNA before symptoms appear. This large, prospective multi-site study is designed to clinically validate the Bluestar Genomics test to detect whether an individual has an abnormal DNA signal associated with pancreatic cancer.
“Most people are unaware that patients recently diagnosed with Type 2 diabetes are at a higher risk for pancreatic cancer, typically resulting in late diagnosis and lack of effective treatments, which is why it’s critical that we identify new methods for early detection of the disease in at-risk populations, said David Halpert, M.D., principal investigator at JEM Research, a Headlands Research Site in Atlantis, Fla. “We are proud to be among the first clinical practices to enroll in the trial that represents an important contribution in a field crying out for something that can give patients a chance.”
The NODMED trial, conducted in collaboration with the PPD clinical research business of Thermo Fisher Scientific Inc., aims to enroll 6,500 patients 50 years of age and older. Trial participants will receive Bluestar Genomics’ DNA-based blood test designed to analyze their changing biology, which can detect when cells become cancerous using the novel 5hmC-based epigenomic analysis.
“Our goal is to enable community doctors to practice medicine at the forefront of innovation, bringing the most cutting-edge care to patients whose lives might be saved with early detection of one of the most lethal cancers,” said Samuel Levy, PhD, chief science officer of Bluestar Genomics. “We want to expand our base of clinical evidence to include even larger and more diverse pools of patient samples to further solidify our 5hmC-based approach for early cancer detection that can also be utilized for many other high mortality cancers.”
About Bluestar Genomics
Bluestar Genomics is an early cancer detection company focused on the development and commercialization of non-invasive epigenomic tests to detect cancer through a standard blood draw, earlier than existing methods and when the disease is still treatable. The company uses its one-of-a-kind epigenomic platform that combines machine-learning-based bioinformatics and genomic technologies to analyze individuals’ changing biology that is yet to produce symptoms. Leveraging its novel liquid biopsy technology, Bluestar Genomics is initially focused on high-mortality cancers with the greatest need for early detection, starting with pancreatic and women’s cancers. With locations in San Diego and the San Francisco Bay Area, Bluestar Genomics collaborates with top research institutions and is supported by multiple global healthcare and technology investors and pharmaceutical collaborations.