CellMax Life’s Cancer Blood Test Designated FDA Breakthrough Device
Molecular diagnostics company CellMax Life’s FirstSight pre-cancer and cancer detection blood test has received the FDA’s Breakthrough Device designation.
The test is designed to detect and measure colorectal neoplasia-associated epithelial cells and DNA markers in human blood. The results, combined with age and gender, are integrated into a proprietary algorithm to generate a result of either low or high-risk for advanced neoplasia.
The test runs on the Sunnyvale, Calif.-based company’s proprietary platform for detecting cancer and pre-cancer.