The results confirmed the test’s diagnostic performance as a biopsy screening tool providing a 91% sensitivity with a 25% specificity. These results are statistically similar in performance to the mass spectrometry assay results which earlier reported the test performing with a 93% sensitivity and a 23% specificity. The P2V™ test is a patent pending combination of two markers, PSP94 and a fragment of vitronectin, for use as a biopsy screen tool for patients with prostate cancer.
“We were very pleased by the performance of the immunoassay, which was developed quickly and efficiently by our team under the direction of Dr. Stephen Frost, and we continue to be impressed by the performance of the markers, which consistently demonstrate the ability to reduce unnecessary biopsies compared to existing techniques”, commented Mr. Christopher J. Moreau, president and CEO of Miraculins.
“The sample set utilized for testing the P2V™ immunoassay was sourced from Miraculins’ internal sample bank and concentrated on 122 men in the critical PSA range of 2.5 ng/ml to 10 ng/ml with a normal digital rectal exam (DRE)”, said Dr. Stephen Frost, director of research and development for Miraculins.
“The samples tested were from both spot collections and 24 hour collections taken during the Company’s last major clinical study. While the 24 hour samples did not show improvement over the spot collection samples in testing for this utility, from a clinical perspective, 24 hour collection may be preferred to reduce variability associated with circadian rhythm. Internal testing by Miraculins confirmed the day to day variation in the PSP94 markers’ expression,“ continued Dr. Frost.
Building on the independent literature for PSP94, the Company also expanded its research on the previously announced second utility for the test as a tool for determining the aggressiveness of a prostate cancer, using the newly developed immunoassay format. P2V’s™ ability to separate aggressive cancers (defined as Gleason score 7 or higher) from healthy, BPH, and non aggressive cancers (Gleason score of 6 or less) with a sensitivity of 90% and a specificity of 51% was confirmed after re-testing 24 hour collection samples from Miraculins’ internal sample bank. Miraculins is continuing to review these results and file additional intellectual property and plans a further update to the market on this utility in the near term.
“We now have a complete package to provide potential partners, which includes solid data from functioning assays”, said Moreau. ” Therefore, Miraculins is now concluding any ongoing research and development on our prostate cancer program and will focus our efforts on finding a suitable development and commercialization partner.”