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CellSearch cancer patient monitor cleared by FDA:

This article was originally published in Clinica

Executive Summary

CellSearch, Immunicon's tumour cell detection kit, has been cleared for sale by the US FDA via the 510(k) route. It is now approved for monitoring patients with metastatic colorectal cancer; in 2004 it gained US clearance for in vitro diagnostic use in patients with metastatic breast cancer. Evaluation of circulating tumour cell (CTC) count at any time during the course of disease allows assessment of patient prognosis and is predictive of progression-free and overall survival. CellSearch is exclusively marketed by Veridex, a subsidiary of Johnson & Johnson, in the cancer field. It is CE-marked in the EU, and final Japanese approval is pending. The Huntingdon Valley, Pennsylvania company has also filed for US approval for prostate cancer, which it expects next year.

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