Bluestar Genomics announced today that it received FDA breakthrough device designation for its pancreatic cancer test.
San Diego-based Bluestar’s proprietary noninvasive pancreatic cancer detection test is designed for use with patients with new-onset diabetes, according to a news release.
The test uses a standard blood draw to assess whether an individual has an abnormal epigenomic and genomic signature associated with pancreatic cancer. The test uses Bluestar’s epigenomics technology platform that utilizes machine learning and the DNA-based 5-hydroxymethylcytosine (5hmC) biomarker to detect cancer, deviating from the standard liquid biopsy cancer tests.
Breakthrough designation was granted based on the evidence of the “uniqueness and robustness” of the company’s cell-free DNA cancer detection approach, the company said.
Bluestar Genomics plans to undertake a large clinical validation study to confirm the performance of pancreatic cancer detection in patients with new-onset diabetes, while the breakthrough nod allows for interaction with the FDA across development, validation and the approval processes.
“Late diagnosis deprives patients of potentially curative treatments and impacts survival rates,” Bluestar Genomics chief medical officer Dr. Kelly Bethel said in the release. “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.”
“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,” added Bluestar chief executive & chief medical officer Samuel Levy. “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.”