Vigilant Receives FDA Breakthrough Designation for Oral Cancer Test

Vigilant Biosciences, a developer of solutions to aid in the early detection of oral cancer, has received Breakthrough Device Designation from the Food and Drug Administration (FDA) for its point-of-care test to aid in the early detection of oral cancer.

The BeVigilant OraFusion Test combined with artificial intelligence software for clinical risk factors determines the presence of certain biomarkers. Early detection, as defined by detection at Stage 1 or Stage 2, can lead to a significantly better outcome, with survival rates of up to 90%. The current oral cancer survival rate is only 50% due to delayed intervention.

Bill Brodie, CEO of Vigilant Biosciences, said: “This Breakthrough Designation is an important milestone in the review process for what we consider to be a life-saving technology. Ongoing clinical results indicate significant benefits to be offered to patients and allow us to continue our mission of providing world-class early detection solutions for the presence of oral cancer.