Diagnostics for prostate cancer

Important results from the project

The aim of the project is to develop an ELISA based method to diagnose prostate cancer. We have previously shown that prostasome determination correlates very well with prostate biopsies. The prostasome assay has several advantages to prostate biopsies. The 4-PLA assay showed that a sensitivity of 1 ng/mL was required. We have worked hard to obtain a sensitivity of 1 ng/mL with a CV of < 10%. We have tested a large number of antibodies and different detection systems without reaching our goal of 1 ng/mL. We have thus not been able to proceed to phase 2 and the evaluation of patient materials.

Expected long term effects

The intended endresult of the project was the development of a prostasome ELISA and a patent protection for the assay. The prostasome assay has several advantages to prostate biopsies, most conspicuously that prostasomes can be recovered from a blood sample herewith circumventing the whole biopsy procedure. We have been granted a Swedish patent and we have also applied for PTC and US patents. During the project we have evaluated a large number of different anti-prostasome antibodies. None of the antibody combinations have yielded sufficient sensitivity in the ELISA.

Approach and implementation

Initially we tried the same antibodies used for the 4-PLA technology in the ELISA, but the sensitivity was not sufficient. We have evaluated a range of commercially available antibodies in the ELISA. Several of these antibodies did not meet the standards specified by the producer and we have been forced to evaluate each antibody with Western blot. We have also started to produce our own monoclonal antibodies. In parallell with the ELISA work we have also unsuccessfully tried the Fiomi palttform for POCT assays as an alternative to ELISA.