Bluestar Genomics, an early cancer detection company for next-gen liquid biopsy tests focused on non-invasive detection of high-mortality cancers in high-risk patient populations, announced the results of a validation study for its early pancreatic cancer detection test.  

Based on the positive study results, Bluestar Genomics initiated a physician experience program to enable patients to gain access to the Bluestar Genomics test, designed specifically for pancreatic cancer detection in people at high risk of developing the disease due to various factors, such as a recent Type 2 diabetes diagnosis. 

“Despite the alarming statistics associated with pancreatic cancer, current diagnostics offerings have limited clinicians’ ability to identify patients with pancreatic cancer at the earliest stages of the disease, when treatments can still be effective,” says Dave Mullarkey, chief executive officer at Bluestar Genomics. “With our focus on high-mortality cancer detection in high-risk patients, we can finally start changing this paradigm by offering clinicians and their patients a better way to identify the disease during its treatable stage.” 

Bluestar Genomics’ epigenomics-based pancreatic cancer signal detection test assesses whether an individual has an abnormal DNA signal associated with pancreatic cancer by measuring levels of the biomarker 5-hydroxymethylcytosine (5hmC). The 5hmC biomarker is stable, sensitive, and precise enough to detect not just the presence of cancer, but to also specify the location.   

The results from the recently completed case-control validation study show the Bluestar Genomics test performing at 67% sensitivity and 97% specificity in a population of 2,150 patients over age 50. Its study cohort included patients recently diagnosed with Type 2 diabetes, a population with eight times the risk of developing pancreatic cancer. The full data will be shared during an oral presentation at the American Pancreatic Association annual meeting.

“Pancreatic cancer remains one of the leading causes of cancer death in the United States, largely due to its frequent diagnosis in later stages when it is less treatable. In fact, the vast majority (65%) of pancreatic cancers are not detected until they have already spread,” says Michelle Welch, MD, practicing endocrinologist at Diabetes and Metabolism Specialists, San Antonio in San Antonio, Texas. “By testing people recently diagnosed with Type 2 diabetes – a known risk factor for pancreatic cancer – we hope to identify this cancer earlier for this group of patients at high risk of the disease.”  

Bluestar Genomics has built a body of scientific and clinical evidence demonstrating the scientific validity and clinical application of its 5hmC-based approach to pancreatic cancer detection. Based on these findings, the company announced the availability of its pancreatic cancer signal detection test for recently diagnosed Type 2 patients aged 50 and older.

 This physician experience program aims to make the Pancreatic Cancer Signal Detection test available to more patients at high risk for developing pancreatic cancer, leading to broader availability in coming months.