BioCurex Inc. (OTCBB:BOCX) today announced results indicating that its RECAF blood test for cancer can prevent 70% of unnecessary prostate biopsies.
In a study to be presented at the ISOBM (International Society of Oncology and Biomarkers) annual meeting in October, BioCurex compared the performance of RECAF and free-PSA to discriminate prostate cancer from benign prostate hyperplasia (BPH), a common benign condition that requires no surgical treatment. The RECAF test outperformed the established free-PSA test by approximately 600% in its ability to prevent unnecessary prostate biopsies.
Men over 50 years of age are screened with PSA (Prostate Specific Antigen) for prostate cancer. PSA is secreted by the prostate but it is not specific for cancer and therefore benign prostate conditions also show elevated PSA. As a result, two thirds of prostate biopsies are cancer negative and are not necessary.
A prostate biopsy is obtained by inserting 6-12 needles into the prostate. The most common procedure is carried out from the rectum following an enema and antibiotic coverage, using ultrasound for guidance. Discomfort, bleeding and infection are the most common complications. Thus, it is important to minimize the number of unnecessary biopsies while still detecting the highest possible number of cancer cases.
To reduce unwanted biopsies, the "free-PSA" test was developed and approved by the FDA. PSA circulates "free" as well as attached to other proteins. In the 1990's, the percentage of free-PSA was shown to be somehow lower in cancer patients than in patients with benign conditions. Unfortunately, the number of unnecessary biopsies prevented by the free-PSA test is only 11-28% as shown in the approved FDA applications from large diagnostic companies.
The BioCurex study was done using blinded samples from two different sources and showed that FDA approved free-PSA tests would have reduced unnecessary biopsies by 11%, whereas the RECAF test, used on the same samples, would have reduced the number of unwanted biopsies by approximately 70% while detecting a comparable percentage of cancers.
The potential commercial impact of these results is very significant, because this is a very specific application for which there is a pressing need and which is not currently addressed in an adequate fashion.
The standard PSA blood test costs between $20 and $60. The free-PSA blood test costs about $100. Medicare and most health insurers typically cover PSA tests for men over 50. It is estimated that in the USA alone - which represents 5% of the worldwide population - over 1.5 million men are eligible for a free-PSA test and therefore also for a RECAF test.
