NEW YORK – Bluestar Genomics said on Tuesday that it has launched a large prospective trial evaluating its epigenomic early cancer detection test to identify pancreatic cancer in people with type 2 diabetes, who are considered high-risk for this type of cancer.
The trial, dubbed New Onset Diabetes Management for Earlier Detection (NODMED), will enroll roughly 6,500 patients over age 50 with recently diagnosed type 2 diabetes, a condition that Bluestar says makes people almost eight times more likely to develop pancreatic cancer. The participants will undergo blood-based testing with Bluestar's epigenomic test, which is designed to measure 5-hydroxymethylcytosine (5hmC) in cell-free DNA.
San Diego-based Bluestar will collaborate with Thermo Fisher Scientific on the multisite trial, which aims to assess the liquid biopsy test's specificity and positive and negative predictive values as primary endpoints.
"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," Samuel Levy, Bluestar Genomics' CSO, said in a statement.
In June, the company shared results from a performance evaluation showing that its test had 55 percent sensitivity and 98 percent specificity in a cohort of 1,433 newly diagnosed diabetes patients.