A liquid biopsy test from Bluestar Genomics can detect a pancreatic cancer signal in people across various age groups, including patients with new-onset diabetes, according to a recent study. The company presented the analytical performance data on its proprietary noninvasive pancreatic cancer test at the recent American Pancreatic Association (APA) annual meeting in Miami Beach.
Bluestar Genomics’ pancreatic cancer test uses a standard blood draw to assess whether an individual has an abnormal DNA signal associated with pancreatic cancer. This test would allow for early diagnosis of pancreatic cancer, which is one of the deadliest cancers in part because there are no existing screening methods to enable early detection.
Early, accurate detection of pancreatic cancer enables more timely, potentially curative surgical and therapeutic options for patients. People with new-onset diabetes are at high-risk of pancreatic cancer. Out of an estimated 60,000 patients diagnosed each year with pancreatic cancer in the United States alone, nearly 25% are found to have new-onset diabetes before a pancreatic cancer diagnosis, according to the company.
“Along with our test’s recent designation by the [U.S. Food and Drug Administration] as a breakthrough device, the findings from this study presented at APA underscore the opportunity we have to make a positive difference for patients by bringing this pancreatic cancer test to market,” says Samuel Levy, PhD, chief executive and chief scientific officer at Bluestar Genomics and lead author of the study. “Based on these results, we are moving forward with completing the analytical validation in the coming months and making a CLIA laboratory developed test available next year.” Unlike other liquid biopsy cancer tests, this pancreatic cancer-focused test is performed with Bluestar Genomics’ epigenomics technology platform that combines machine learning with a DNA-based 5-hydroxymethylcytosine (5hmC) biomarker as a precise screening method for detecting cancer at earlier stages. By combining a novel 5-hydroxymethylation enrichment assay with high-throughput sequencing, it is possible to generate powerful predictive models using machine learning to enable the detection of pancreatic cancer in patients with high accuracy, according to the company.
Pancreatic cancer is the third leading cause of cancer death in the United States, surpassing common cancers such as breast and prostate. According to the company, the Bluestar Genomics’ test has the potential to screen an estimated one million adults diagnosed annually with new-onset diabetes in the United States for the early detection and treatment of pancreatic cancer, which could enable better patient outcomes.
The study presented at APA included 917 patients, examining whole blood samples from 117 patients with pancreatic cancer and 800 non-cancer control patients, with and without new-onset diabetes. The predictive model was trained on samples using 5hmC signals from cell-free DNA. When applied to the validation set, 50% of which were early stage (stages I and II) disease, this model showed a median of 51.5% sensitivity and 98% specificity.
Results from the study demonstrated pancreatic cancer signal detection in plasma-derived, cell-free DNA using 5hmC profiles. Overall, these findings showed that the model performed consistently well between the training and independent validation datasets, according to the company.
In addition to completing the analytical validation, Bluestar Genomics is planning a large clinical study to further validate the use of this test to detect pancreatic cancer in patients with new-onset diabetes.
With the commercialization efforts for the test focused on pancreatic cancer as well as a growing pipeline of other epigenomic assays, the company also announced that Jim Vaughn, RPh, has joined the company as its chief commercial officer (CCO).
“Liquid biopsy continues to show great promise in improving cancer patient survival,” Vaughn says. “Our epigenomics approach is to focus on the highest-risk cancers with the greatest needs, starting with pancreatic and certain women’s cancers. I look forward to leading our efforts to bring new-generation liquid biopsy tests to physicians and patients to enable curative therapies.”
Vaughn brings more than 20 years of experience in commercializing molecular tests in oncology, including expertise in sales, marketing, and reimbursement strategy. Most recently, Vaughn has led efforts to commercialize the Oncotype DX portfolio at Genomic Health/Exact Sciences, where he was the global chief commercial officer.
“The positive data at APA along with Jim’s appointment as CCO provide confidence for the company to move forward with commercial planning for our first product, with the goal of developing a pipeline of tests employing our unique type of epigenomics analysis,” Levy says.
For more information, visit Bluestar Genomics.