New Test Helps Diagnose Prostate Cancer

A new in vitro diagnostic (IVD) test kit, featuring monoclonal antibodies, will help pathologists diagnose prostate cancer, one of the most difficult cancers to diagnose from biopsied material.

Signet Laboratories Inc. (Dedham, MA, USA), and AsymmetRx Inc. (Amston, CT, USA), have announced an exclusive agreement for the distribution of the Prostate-63 diagnostic test, which has been cleared by the U.S. Food and Drug Administration (FDA). The new kit, jointly developed by the two companies, will be exclusively marketed by Signet laboratories. It is the first in a series of kits that use p63 to diagnose prostate cancer.

The p63 protein is a member of the p53 family and is expressed in the nucleus of basal cells in the epithelium. Markers of basal cells are useful in diagnostic pathology, particularly when examining difficult prostate biopsies. The p63 gene was discovered by AsymmetRx founder Dr. Frank McKeon. The gene is localized to the nucleus of cells and offers advantages over cytoplasmic markers. The Prostate-63 diagnostic test features a mouse monoclonal antibody that recognizes prostatic basal cells and urothelial tissues.

Signet Laboratories is a medical diagnostics/research company specializing in the development of monoclonal antibodies and diagnostic assays for cancer, infectious disease, and neurodegenerative disease.



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