NEW YORK (GenomeWeb News) – Gen-Probe announced after the close of market on Tuesday that it has filed a Premarket Approval application with the US Food and Drug Administration for its prostate cancer assay.
The test, called Progensa PCA3, may help in determining whether repeat biopsies are needed in men suspected of having prostate cancer, Gen-Probe said in a statement.
Progensa PCA3 tests urine samples from men who have had a negative prostate biopsy. Gen-Probe conducted a prospective, multisite clinical study with 507 men in support of its PMA application, it said.
The test is CE marked and is the first urine-based molecular diagnostic test for prostate cancer, according to Gen-Probe, which acquired worldwide diagnostic rights to the PCA3 gene from DiagnoCure in November 2003.
The PCA3 gene is overexpressed in more than 90 percent of prostate cancers, Gen-Probe said, and can be measured in urine after a digital rectal exam. It added that the gene is highly specific for prostate cancer and predicts the results from repeat biopsies more accurately than traditional PSA testing.
Gen-Probe President and CEO Carl Hull said in a statement that the PMA application for the test is the second of four regulatory submissions that the company expects to make in the US before the end of 2010.
Its Prodesse ProFast+ assay for the simultaneous detection of seasonal A/H1, seasonal A/H3, and 2009 H1N1 received FDA clearance in July.