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Immunicon Corp. has filed a request for FDA clearance of a product designed to aid in monitoring patients with metastatic androgen-independent prostate cancer. According to the company, the CellSearch Circulating Tumor Cell Kit has successfully met its primary endpoint, demonstrating that circulating tumor cell levels 3 to 5 weeks after the initiation of chemotherapy predict overall survival.
Immunicon Corp. has filed a request for FDA clearance of a product designed to aid in monitoring patients with metastatic androgen-independent prostate cancer. According to the company, the CellSearch Circulating Tumor Cell Kit has successfully met its primary endpoint, demonstrating that circulating tumor cell levels 3 to 5 weeks after the initiation of chemotherapy predict overall survival.
Study results presented at the 2007 American Society of Clinical Oncology annual meeting also showed that circulating tumor cell levels predict overall survival at each of the additional monthly time points tested. Furthermore, the research team said serial circulating tumor cell measurements taken before and after initiation of therapy in men with androgen-independent prostate cancer delivered more reliable information about disease progression and patient survival months earlier than did changes in PSA measurements.
The CellSearch test currently has FDA clearance for metastatic breast and colorectal cancer.