Nucleic acid probe-based product maker Gen-Probe Inc.(GPRO), Thursday said it initiated a clinical trial intended to secure U.S. regulatory approval for its PROGENSA PCA3 assay, a new molecular test that would help determine the need for a repeat prostate biopsy. The test has already been CE-marked for sale in the European Union, and is also the first urine-based molecular diagnostic assay for prostate cancer.
The test, however, has not been approved for marketing in the United States. Earlier in November 2003, Gen-Probe has acquired exclusive worldwide diagnostic rights from DiagnoCure (CUR.TO) to the PCA3 gene, which is highly over-expressed in more than 90%.
Gen-Probe revealed plans to submit a pre-market Approval Application or PMA with the U.S. Food and Drug Administration following the completion of the the clinical study within less than a year. Five hundred men, all of whom have had a negative prostate biopsy, at 10 or more clinical trial sites are expected to participate in the study.
Data from more than 20 peer-reviewed publications indicated that PROGENSA PCA3 assay, when used in conjunction with other patient information, would help urologists overcome certain challenges they face when identifying prostate cancer, such as minimizing unnecessary biopsies.
Gen-Probe, quoting the American Cancer Society, said prostate cancer is the second most common type of cancer found in American men, the first being skin cancer, and the second in causing death after lung cancer.
PCA3 is a gene that can be quantified in urine specimens following a digital rectal examination and some studies have indicated the gene as highly specific for prostate cancer. It predicts the results of repeat biopsies more accurately than traditional prostate-specific antigen - PSA- testing.
GPRO closed Thursday's trading at $39.32, down $0.24 or 0.61%, on a volume of 0.483 million shares.
CUR.TO closed Thursday's trading at $0.91, up $0.01 or 1.11%, on a volume of 0.47 million share.
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