NEW YORK (GenomeWeb News) – Gen-Probe announced after the close of the market on Monday that it has submitted a 510(k) application to the US Food and Drug Administration for its Aptima Trichomonas vaginalis assay that runs on the company's fully automated Tigris system.
The assay already is CE marked for sale in Europe.
In a statement, Gen-Probe President and CEO Carl Hull said the assay uses the same technology as its Aptima tests for Chlamydia and gonorrhea and can be used with the same female samples. "We believe our Trichomonas vaginalis assay will contribute significantly to women's health and provide a convenient tool for physicians and laboratories," he said.
Testing for trichomonas is traditionally done by culture methods, which are slow and less sensitive than molecular tests, Gen-Probe said. Citing statistics from the US Centers for Disease Control and Prevention, the company said that 7.4 million American men and women are infected with trichomonas annually.
Hull said that its application to FDA is the third of five that the company plans to complete in 2010. "Taken together, we expect these new products to start an important new sales growth cycle for the company," Hull said.
Two weeks ago, Gen-Probe submitted a pre-market approval application to FDA for a prostate cancer assay. In July, the company received FDA clearance for an assay for the simultaneous detection of three Influenza A virus subtypes.