Beckman Brings phi For PCA Detection To US
Beckman Coulter Diagnostics ( Danaher) has reported the national availability of the Prostate Health Index (phi), a non-invasive blood test that is three times more specific in detecting prostate cancer (PCA) than PSA. The test's accuracy decreases the need for many men who test positive for elevated PSA levels to undergo a biopsy in order to achieve a reliable diagnosis. The phi test is now available to physicians nationwide through Innovative Diagnostics Laboratory.
The phi is indicated for use as an aid in distinguishing PCA from benign prostatic conditions, for PCA detection in men aged 50 years and older with total PSA >= 4.0 to =< 10.0ng/mL, and with digital rectal examination findings that are not suspicious for cancer.
The most widely used screening test for prostate cancer is currently the PSA test, which measures the blood's level of PSA-a protein that is naturally produced by the prostate gland and is typically increased when cancer is present. However, it is widely recognised that PSA results can often indicate the possibility of prostate cancer when none is present. The substantial increase in accuracy of the phi test over PSA addresses this concern. Results of a multicentre clinical study found a 31% reduction in unnecessary biopsies due to false-positives as a result of using the phi test.
The phi test helps physicians distinguish prostate cancer from benign conditions by utilising three different PSA markers (PSA, freePSA and p2PSA) as part of an algorithm to more reliably determine the probability of cancer in patients with elevated PSA levels.