IsoPSA, from Cleveland Diagnostics, is a blood test that detects prostate cancer more precisely than currently available tests. IsoPSA is able to distinguish cancer from benign conditions and identify men who have a high-risk disease, reducing the need for unnecessary prostate biopsies.

How IsoPSA works

IsoPSA identifies molecular changes in a protein called prostate specific antigen, which is exclusively produced by cells of the prostate gland. Men with prostate cancer usually have abnormally high levels of PSA. Standard PSA tests measure the level of PSA in men’s blood.

Although elevated blood levels of PSA is often an indication of prostate cancer, other benign (not cancerous) conditions such as  inflammation of the prostate (prostatitis) and an enlargement of the prostate called benign prostatic hyperplasia (BPH) can also cause PSA levels to rise.

Unlike currently available PSA tests, IsoPSA identifies structural changes in the PSA protein that directly relate to cancer mutations, potentially reducing the need for biopsies and lowering the detection of benign conditions. It does this through a solvent interaction analysis. When polymers and salts are mixed in water, two distinct immiscible (incapable of mixing) phases are formed. When a blood sample is placed in this two-phase system, the different forms of all proteins stay either at the top or bottom phase depending on their structure and interaction with other proteins. The ratio of PSA protein found in the top and bottom layer can then be compared to the ratio in a sample obtained from a prostate cancer patient and used as a quantitative parameter to help diagnose prostate cancer.

IsoPSA research

The results of a multi-center prospective pilot study with IsoPSA assay were published in the scientific journal European Urology. The study included 261 men who had been scheduled for a prostate biopsy at five centers in the U.S., and assessed the clinical performance of IsoPSA in comparison to a standard PSA test.

The IsoPSA assay outperformed concentration-based PSA measurements and provided a net benefit against other clinical protocols. The performance of the IsoPSA test was better in two key ways: it discriminated between prostate cancer and benign conditions and it identified men at high-risk of prostate cancer. According to the company, these results suggest that if IsoPSA is adopted for daily clinical routine, it could reduce the need for biopsies by almost 50 percent.

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