Immunicon’s cancer diagnostic kit receives FDA approval

A sample of the patient’s blood is processed with the CellSearch Kit using the CellTracks System to capture and count CTCs. This clearance represents another expansion to claims for the kit, which is now cleared for three of the four most prevalent cancers. The CellSearch Circulating Tumor Cell Kit was developed by Immunicon and is exclusively marketed by Veridex.

Byron Hewett, CEO and president of Immunicon, said: “Because the three pivotal trials demonstrated that the CellSearch test predicts survival in prostate, breast and colorectal cancers, circulating tumor cell testing should become standard of care in the management of patients with metastatic disease. More importantly, oncologists can use the results to make better-informed treatment decisions and improve patient care for three of the top carcinomas.”