WINNIPEG, Manitoba – February 10th, 2009 – Miraculins Inc. (TSX-V:MOM), a medical diagnostic company focused on developing and commercializing diagnostic tests for unmet clinical needs, is pleased to announce results which demonstrate that PSP94 in urine can be used to improve the performance of free over total (F/T) PSA ratio in detecting aggressive prostate cancer. The improvement offered by PSP94 is believed to be a novel discovery.
“The free PSA test is marketed by a number of large diagnostic companies and this discovery of the improvement offered by PSP94 is a tremendous addition to our prostate cancer package. We believe that this discovery could help significantly improve and differentiate the standard free PSA test,” said Christopher Moreau, President and Chief Executive Officer of Miraculins Inc.
In Miraculins’ recent immunoassay testing, the Company successfully demonstrated that standardized PSP94 combined with F/T PSA ratio was able to differentiate men with aggressive prostate cancer (Gleason Score of 7-10, n=18) from men with favorable pathologies (Gleason Score of 6 or less, BPH or healthy men, n=70) with a sensitivity of 94% and specificity of 49% (AUC=0.80). This result was much stronger than the individual performance of F/T PSA in the same samples, which had a sensitivity of 94% and specificity of 16%. When men with the confounding condition of hypertension were removed from testing, the combination yielded even better results and successfully separated the same populations with a sensitivity of 100% and a specificity of 84% (AUC=0.87, n=7 aggressive cancer and n=37 favorable pathologies).
“These results are important because they support the use of PSP94 in combination with F/T PSA ratio as a tool to help patients avoid unnecessary suffering from prostate cancer,” stated Dr. Stephen Frost, Director of Research and Development for Miraculins. “As prostate cancer is often slow-growing, a number of men are currently engaged in watchful waiting programs as opposed to more aggressive treatment regimens. With a reliable tool for determining prostate cancer aggressiveness, only the highest risk patients would require repeat biopsy and therefore the physical and psychological cost of biopsies for men with non-aggressive forms of the disease could be avoided. A tool of this type may also enable more men to pursue watchful waiting as a treatment option.”
“Additionally, a number of patients who have aggressive prostate cancer may not normally be referred to biopsy, such as men in the lower PSA range or those considered too old for PSA screening. These men could also benefit from a test which would allow those with aggressive forms of the disease to seek appropriate medical treatment,” added Dr. Frost.
“The need for improved, non-invasive diagnostic tools for determining the aggressiveness of prostate cancer is well known and interest in this research area is growing within the scientific and medical fields. We believe that our discovery can make a contribution to this effort,” concluded Moreau.
About Miraculins Inc.
Miraculins is a medical diagnostic development company focused on non-invasive tests for unmet clinical needs. Miraculins is bridging the gap between commercially available diagnostic tests and research conducted at leading research institutions around the world.
About F/T PSA Testing
PSA exists in several forms in the blood including bound to proteins and free (unbound). Free PSA is known to contribute to the diagnosis of prostate cancer when total PSA is modestly elevated, in addition to having been associated with prostate cancer aggressiveness in the literature. F/T PSA is based on a measurement of conventional (total) PSA and free PSA.
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