Proteome Systems, Egenix to develop prostate cancer diagnostic kit

By Ted A. Knutson

Washington, March 7 - Proteome Systems Ltd. said Tuesday it has signed an agreement with Egenix Inc. to co-develop a semen-based diagnostic kit for prostate cancer based on the known proprietary Human Carcinoma Antigen (HCA).

The new non-invasive test, once developed, would offer significant advantages over the current test and would reduce unnecessary invasive examinations as well as needle biopsies.

The current blood test for prostate cancer measures levels of prostate-specific antigen (PSA). The drawback with the PSA test is that it has a high false positive rate, estimated at up to 75%, meaning it picks up many benign conditions of raised PSA levels in the blood - such as enlargement of the prostate or a prostate infection.

This means that many men who have false positive tests for prostate cancer undergo unnecessary biopsies.

Proteome said research indicates that the HCA-based test being developed by it and Egenix would be a more accurate test.

Initial data testing HCA in semen as a marker of prostate cancer was presented at an American Urology Association meeting. In a cohort of 84 patients (nine confirmed cancers and 75 non-cancers), the sensitivity of the semen test was 100% (no cancers missed) and the false positive rate was only 17%.

Proteome and Egenix will initially work together to optimize the detection of HCA in semen of prostate cancer patients. This initial project will be fully funded by Egenix. The two companies will then share the rights for further development and commercialization of the test.

The parties envisage that this test would have significant implications for the prostate cancer diagnostic market. Estimates by Egenix indicate a potential market size for the HCA test of up to $1.5 billion in the U.S. market.

HCA in the blood can signal the presence of cancer, but it does not specify where the cancer exists as HCA is produced by other tumors such as breast, lung and colon cancers. Because the prostate's function is to secrete fluid into semen, HCA is found in much larger concentrations in semen produced by cancerous prostates and is therefore expected to be a highly specific marker for prostate cancer.

Further programs using HCA for detection of other cancers are envisaged upon the completion of the initial prostate cancer test.

Egenix is a New York-based biotechnology company.

Proteome is a North Ryde, Australia-based biotechnology firm.

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