Healthcare Industry News:  p53 

Diagnostics Oncology Distribution

 News Release - February 21, 2006

Signet Laboratories, Inc. and AsymmetRx, Inc. Announce Exclusive Agreement for Distribution of FDA 510(k) Cleared Diagnostic Tests ('Prostate-63') for the Diagnosis of Prostate Cancer Using p63

Leading medical diagnostics/research company announced today exclusive distribution agreement with AsymmetRx, Inc. for the only FDA cleared, patented test to diagnose prostate cancer

DEDHAM, Mass., Feb. 21 (HSMN NewsFeed) -- Signet Laboratories, Inc., today announced the signing of an agreement with Connecticut-based AsymmetRx, Inc. providing exclusive distribution of their patented, FDA 510(k) cleared Prostate-63 (IVD) Prostate Cancer Diagnostic Test Kit using p63. The new kit, jointly developed and exclusively marketed by Signet Laboratories, is the only FDA cleared prostate cancer diagnostic test kit. It is the first in a series of kits that uses p63 to diagnose prostate cancer.

AsymmetRx, Inc. holds the exclusive, worldwide license under the Harvard Medical School patent filings (including U.S. Patent 6,946,256) for the use of p63 antibodies to diagnose prostate and other cancers, and has recently received 510(k) clearance from the FDA for the use of p63 as an IVD (In Vitro Diagnostic) test to aid pathologists in diagnosing prostate cancer. The p63 gene was discovered in the Harvard lab of AsymmetRx founder Dr. Frank McKeon and the p63 prostate cancer diagnostic test was invented by a collaboration of labs at Harvard and Harvard-affiliated hospitals.

Maria McKeon, AsymmetRx's President & CEO said, "Prostate cancer is one of the most difficult cancers to diagnose from biopsied material, and the p63- based test adds a significant advantage to making a correct diagnosis. This kit ushers in the only FDA cleared prostate cancer test, which aids pathologists in the differential diagnosis of prostate cancer in conjunction with morphological findings. Numerous articles in top clinical journals have cited the accuracy and utility of p63 for prostate cancer diagnosis." Paul Fluckiger, Signet's President & COO stated, "This is an exciting and important opportunity for both of our companies to embark on the development of a series of kits that provide improved diagnostics for prostate cancer patients. We are both committed to the provision of only the highest quality solutions for affected patient populations."

The p63 protein is a member of the p53 family, which also includes p73, 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. Because p63 is localized to the nucleus of cells, it can offer distinct advantages over cytoplasmic labeling. The Prostate-63 Prostate Cancer Diagnostic Test Kit features a mouse monoclonal antibody, clone 4A4, that recognizes the human p63 protein in the nucleus of prostatic basal cells and urothelial tissues (Yang et al., 1998; Signoretti et al., 2000).

About Signet Laboratories, Inc.

Signet Laboratories, Inc. (Dedham, MA), is a leading medical diagnostics/research company specializing in the development of monoclonal antibodies and diagnostics assays for cancer, infectious disease, and neurodegenerative disease. Signet was created in 1989 as a commercial spinout of Johnson & Johnson's Cambridge Research Laboratories, Inc. (Cambridge, MA).

The Company was founded to continue the mission originally established at CRL -- the early detection and recurrence monitoring of patients with cancer and infectious disease. Signet has developed patented technology for diagnosis and recurrence monitoring and for risk assessment of asymptomatic patients in these areas. For more than a decade, the Company has aggressively maintained licensing and development programs, which are responsible for its broad patent and intellectual property estate.

About AsymmetRx

AsymmetRx, Inc. was founded in 2001 by scientists from Harvard University and Johns Hopkins University to develop novel diagnostics, imaging agents, and therapies for urologic cancers including those affecting the bladder and prostate. Using strategies based on key advisors from private and academic clinicians and pathologists specializing in urologic cancers, AsymmetRx is committed to developing the most accurate tests for the analysis of prostate and bladder biopsies, as well as early detection tests that in the future will obviate the need for needle biopsies.

AsymmetRx is committed to developing systems of imaging urologic cancers that will aid in the early treatment of such diseases, as well as therapies based on specific targeting of malignant cells in urologic cancers. AsymmetRx recently succeeded in developing the first FDA cleared test for prostate cancer in needle biopsies based on the p63 antibody. It is anticipated that the p63-based test will assist in the accurate diagnosis and treatment of hundreds of thousands of men in the United States alone. More detailed information on the company and its mission may be found at http://www.asymmetrx.com.



Source: Signet Laboratories

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