CeMines Files 510(k) for Its CellCorrect LAb Detection Kit

CeMines has filed a 510(k) application with the FDA seeking clearance for clinical use of the company's first minimally invasive cancer detection kit, CeMines CellCorrect LAb.

The test detects altered autoimmunity and associated patterns (molecular fingerprints) of disease-related autoantibodies in the bloodstream. CeMines has conducted extensive clinical studies that demonstrated that specific and consistent patterns of certain antibodies have regularly proven their utility as composite biomarkers to characterize cancer, and can therefore be used as diagnostic tests for cancer.

The company uses a bioinformatics-based statistical pattern recognition application, CeMines Molecular FingerPrinting, which evaluates patterns of certain antibodies and the profiles of cancer patients. These data are presented to assist physicians in the diagnosis of cancer.