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Immunicon’s CellSearch Circulating Tumor Cell (CTC) Kit has received FDA clearance as an aid in the monitoring of patients with metastatic prostate cancer.

The kit is now cleared for three of the four most prevalent cancers; a combined ≈$1 billion market, according to the company.

The CellSearch CTC kit was originally cleared in January 2004 to predict progression-free and overall survival in patients with metastatic breast cancer and later expanded to include monitoring. In November 2007, the kit was cleared by the FDA for monitoring metastatic colorectal cancer.

The American Cancer Society estimates that in 2006 there were 1.4 million new cancer cases diagnosed and 564,000 deaths. Close to 90% of all cancers are solid tumors or carcinomas. Computed tomography (CT) scans are standard for tracking the progression of carcinomas by assessing changes in tumor size, but CT scans are highly subjective and for best results measurement takes place over long intervals of time, potentially allowing the carcinoma to metastasize.

Immunicon’s CellSearch addresses these inadequacies using blood samples to counts and characterizes the number of tumor cells present in a blood sample.

The CTC Kit has better predictive power than serum tumor markers and CT scans and is performed more regularly – every 3-4 weeks versus every 3-6 months. The Kit is able to predict survival time in patients undergoing chemo and hormonal therapy. It helps oncologists determine if a therapy is working, allowing them to manipulate a course of treatment with much greater speed.

In August 2000, Immunicon entered into an exclusive partnership with Veridex, a J&J subsidiary. Under the terms of the agreement Veridex is responsible for all marketing, sales and distribution. The revenues are shared, except for reagents for which Immunicon receives 30%.  Reimbursements are also the responsibility of Veridex —CPT codes exist for most products.