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news.Miraculins, a biotechnology company, has announced that it will be conducting a second pivotal pre-biopsy screen study for its urine based P2V prostate cancer diagnostic test.
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The study will focus on men who have been referred to urologist and subsequently have been selected for a prostate biopsy, but will be restricted to men who have a prostate-specific antigen (PSA) score of between 2.5ng/ml and 10ng/ml with a normal digital rectal exam result.
The objective of the study will be to determine the effectiveness of the P2V test in reducing the number of unnecessary biopsies in this key group of patients by being able to screen out the men who have been selected for a prostate biopsy based strictly on their elevated PSA score, but who do not have prostate cancer.
In addition, the company plans on testing the samples from this second pivotal study using immunoassays for both PSP94 and Vitronectin, the proteins that form the P2V panel assay. Miraculins has already initiated development of these assays. The company has completed the study protocol and is expected to begin the study in approximately 30 days. The projected timeframe for completion is six months from the beginning of the study.
Christopher Moreau, president and CEO of Miraculins, said: “This second pivotal study is in part a result of the feedback that the company received from the FDA on its pre-IDE submission, which was especially helpful in focusing our attention on the most serious deficiency in correctly diagnosing men who are suspected of having prostate cancer.”