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BioWorld - Wednesday, December 24, 2025
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Home » Bluestar Genomics gets breakthrough nod for pancreatic cancer screening test
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Bluestar Genomics gets breakthrough nod for pancreatic cancer screening test

April 1, 2021
By Meg Bryant
Pancreatic cancer is the third leading cause of cancer death in the U.S., in part because many cases aren’t diagnosed until they are advanced. Bluestar Genomics Inc. wants to change that with its epigenomics technology which can detect early pancreatic cancer from a standard blood draw by analyzing cell-free DNA in plasma. Now, the FDA has provided a bump, granting breakthrough device designation to Bluestar’s noninvasive pancreatic cancer detection test in patients with new-onset diabetes. According to the San Diego-based startup, of an estimated 60,000 patients diagnosed with pancreatic cancer in the U.S., nearly a fourth are found to have new-onset diabetes prior to receiving their cancer diagnosis.
BioWorld MedTech Regulatory Cancer Diabetes Diagnostics Liquid biopsy FDA

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