Bluestar Genomics Receives FDA Breakthrough Device Designation for First-of-Its-Kind Pancreatic Cancer Screening Test

Company accelerates commercialization efforts to address a million at-risk patients’ unmet needs

SAN DIEGO--(BUSINESS WIRE)--Bluestar Genomics announces today it received U.S. Food and Drug Administration (FDA) Breakthrough Device designation for its proprietary noninvasive pancreatic cancer detection test in patients with new-onset diabetes.

The FDA’s Breakthrough Device program accelerates the development of medical devices that have the potential to effectively treat or diagnose life-threatening or irreversibly debilitating diseases. Bluestar Genomics’ pancreatic cancer test uses a standard blood draw to assess whether an individual has an abnormal epigenomic and genomic signature associated with pancreatic cancer. Unlike current liquid biopsy cancer tests, this new test is performed with Bluestar Genomics’ groundbreaking epigenomics technology platform that employs state-of-the-art machine learning coupled with the DNA based 5-hydroxymethylcytosine (5hmC) biomarker as a screening method to detect cancer sooner.

Pancreatic cancer is the third-leading cause of cancer death in the U.S., surpassing common cancers such as breast and prostate. Out of an estimated 60,000 patients diagnosed with pancreatic cancer in the U.S. alone, nearly 25% are found to have new-onset diabetes before a pancreatic cancer diagnosis. With this designation, Bluestar Genomics’ test can help screen an estimated one million adults diagnosed annually with new-onset diabetes in the U.S. for early detection and treatment of pancreatic cancer to enable better patient outcomes.

“Late diagnosis deprives patients of potentially curative treatments and impacts survival rates,” said Kelly Bethel M.D., chief medical officer, Bluestar Genomics. “In contrast, when detected at an early stage, patients can be eligible for surgery, which can be curative. Therefore, early detection is paramount for giving patients better treatment options to potentially improve outcomes.”

Bluestar Genomics’ 5hmC assay has been shown to detect pancreatic cancer-derived signatures in a patient’s blood by evaluating 5-hydroxymethylcytosine changes in DNA that define biological activity in disease-relevant genes.

With multiple publications demonstrating the feasibility and validity of Bluestar Genomics’ test, the FDA granted its breakthrough designation based on the growing body of evidence demonstrating the uniqueness and robustness of the company’s novel cell-free DNA cancer-detection approach. Furthermore, Bluestar Genomics is undertaking a large clinical validation study confirming the performance of pancreatic cancer detection in patients with new-onset diabetes. The breakthrough designation allows timely interaction with the FDA across the test development, validation and approval processes.

“Currently, there are no screening methods to enable early detection of pancreatic cancer, while early, accurate detection has the potential to significantly improve prognosis by enabling better therapeutic options for patients,” said Samuel Levy, Ph.D., chief executive and scientific officer, Bluestar Genomics. “With FDA’s designation, combined with continued collaboration with top research institutions, our goal is to accelerate important clinical validation studies to bring our pancreatic cancer test to market in the coming years and continue to extend our efforts toward a multi-cancer screening test.”

About Bluestar Genomics

Bluestar Genomics, an epigenomics-based molecular cancer testing company, develops next-generation epigenomic approaches to detect deadly cancers, such as pancreatic, early when curative therapies are possible. Founded out of Dr. Stephen Quake’s Stanford laboratory, Bluestar Genomics combines novel epigenomic technologies with its novel machine-learning architecture to tackle the most urgent challenges in cancer detection. Leveraging the ease of liquid biopsy technologies, the company’s cell-free DNA-based assays target early cancer detection using simple and noninvasive blood draws to improve outcomes and save lives. Led by a team with decades of experience bringing products from concept to market, Bluestar Genomics is continuously seeking better ways to measure disease pathology and bring its technologies to the patients, clinicians, scientists and investors searching for tomorrow’s cures. www.bluestargenomics.com