CytoBloom Biopsy

The cholangiocarcinoma patient population represents 4.6% of cancer deaths in the United States annually with a 17.5% post-diagnostic 5-year survival rate. It is defined as a malignant tumor in the bile duct, and early and accurate diagnosis is critical for survival. The brush biopsy is the standard of care as a non-invasive initial diagnostic tool in determining the malignancy of a bile duct lesion. However, the current brush biopsy has significant shortcomings, with a sensitivity between 23% and 71% depending on the study. This corresponds to a high false-negative rate, forcing patients to undergo more invasive and more dangerous biopsy techniques as much as 38% of the time. The CytoBloom Biopsy seeks to eliminate the need for more invasive biopsy techniques by collecting a superior cellular yield, enabling pathologists to determine an accurate diagnosis after a single non-invasive biopsy procedure.