The FDA breakthrough designation is based on the evidence showing feasibility and validity of Bluestar’s molecular test and its novel cell-free DNA cancer-detection approach
Bluestar Genomics has received the US Food and Drug Administration (FDA) Breakthrough Device designation for its non-invasive pancreatic cancer detection test in patients with new-onset diabetes.
The new pancreatic cancer test uses a standard blood draw to evaluate whether an individual has an abnormal epigenomic and genomic signature associated with pancreatic cancer.
The molecular cancer testing provider said that, unlike other liquid biopsy cancer tests, its new test leverages its epigenomics technology platform.
The platform combines advanced machine learning with the DNA based 5-hydroxymethylcytosine (5hmC) biomarker as a screening method for rapid detection of cancer.
It detects the pancreatic cancer-derived signatures in the blood by assessing 5-hydroxymethylcytosine changes in DNA that define biological activity in disease-relevant genes.
Bluestar Genomics chief medical officer Kelly Bethel said: “Late diagnosis deprives patients of potentially curative treatments and impacts survival rates.
“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.”
The company said that the breakthrough designation will support screening an estimated one million adults in the US with new-onset diabetes, facilitating early detection and the treatment of pancreatic cancer.
The FDA breakthrough designation is based on the evidence showing feasibility and validity of the company’s molecular test and its novel cell-free DNA cancer-detection approach.
Bluestar Genomics is conducting a large clinical validation study to confirm the performance of pancreatic cancer detection in patients with new-onset diabetes.
The company expects that the breakthrough designation will allow timely interaction with the FDA during the development, validation and approval of the test.
Bluestar Genomics chief executive and scientific officer Samuel Levy said: “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.
“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.”