NEW YORK – Biological Dynamics said this week that it has partnered with the Pancreatic Cancer Early Detection (PRECEDE) Consortium for a validation study of its ExoVita pancreas assay, an exosome-derived blood-based test utilizing the firm's Verita platform.
The company received breakthrough device designation from the US Food and Drug Administration in 2021. In data presented at this year's annual meeting of the American Association for Cancer Research, investigators from the company reported that they were able to discriminate between stage I and II cancers and healthy control samples with a sensitivity of 93.3 percent and 91 percent specificity.
The current study, ExoLuminate, was initiated in late 2022 and aims to recruit a minimum of 1,000 US adults over two years with one year of follow-up for data collection. In its press release, Biological Dynamics cited a total enrollment goal of approximately 5,000 patients.
Pancreatic cancer usually shows little or no symptoms until it has advanced and spread. As a result, it is often diagnosed in stages III or IV, leaving patients and clinicians with limited treatment options and lowering chances of survival.
"In order to go from a 12.5 percent survival rate to a 50 percent survival rate … the answer will lie in significantly improving surveillance and accelerating detection of pancreatic cancer at stages I or II with a blood-based assay," Biological Dynamics Medical Director and study Principal Investigator Harmeet Dhani said in a statement.