New prostate cancer test

Mar 28 2005

Tessera, Inc., a Seattle-based biomedical company, has released its first product, ProstaMark EPCA (Early Prostate Cancer Antigen), as an Analyte Specific Reagent (ASR) for commercial use in pathology laboratories to assist pathologists in their efforts to determine if cancer is present in the prostate.

Tessera's EPCA test is now available at Unipath, LLC (Denver, Colorado) and will soon be offered by pathology laboratories throughout the country, as well as major prostate cancer centers. Pathologists will use the test to assist in the detection of prostate cancer in biopsy tissue samples, in ways not currently possible, and will then report their findings to the patient's urologist.

Unipath has the largest pathology practice in the Rocky Mountain Region with 25 pathologists and supporting staff and management. CEO Tricia Hughey states: "Unipath is pleased to now offer Tessera's EPCA antibody for predictive testing in prostate carcinoma. Utilized in conjunction with standard evaluation procedures, we believe the EPCA test will be an important tool in the ongoing surveillance of prostate cancer patients. In addition, we predict that EPCA will contribute positively to the future control of prostate cancer."

Dr. Ralph Giorno, M.D. and Medical Director of Unipath, further states that "EPCA has great potential as a biomarker in the evolution of clinical management of patients at high risk of developing prostate cancer. Once again, Unipath is taking pathology to the next level."

Published in the April 2004 Issue of the Journal of Urology, study findings from Dr. Robert Getzenberg, Director of the Brady Urological Research Institute at Johns Hopkins, indicate that prostate cancer can be detected as many as five years earlier than it is currently being diagnosed, by testing for the EPCA protein in biopsy tissue samples. Dr. Getzenberg explained that EPCA is a protein that indicates the earliest changes that occur in cells during the development of cancer.

A second independent EPCA study from Kagawa University in Japan has been accepted for publication in the Journal of Urology later in 2005. The Japanese study supports Dr. Getzenberg's original findings.

Tessera has licensed more than 60 markers from John Hopkins University and the University of Pittsburgh. EPCA is the first of these markers to be commercialized by Tessera, and the Company expects to launch a second product for the early detection of colon cancer later in 2005. In addition, Tessera is currently working on the development of blood tests for both prostate and colon cancer and expects to commence clinical trials on its first blood test for prostate cancer before the end of the year. Dr. Getzenberg's first manuscript on the EPCA prostate cancer blood test has been accepted for publication in the May 2005 edition of Cancer Research.

According to Dr. Getzenberg, "Our ultimate objective is to differentiate between aggressive and non-aggressive forms of prostate and colon cancer. Through our collaboration with Tessera over the past three years, we are making significant progress toward the achievement of this important goal."

Tessera has contracted Chemicon International, a subsidiary of Serologicals, Inc., located in Temecula, CA, to manufacture the ProstaMark EPCA product.