Gen-Probe has received the US Food and Drug Administration (FDA) clearance for marketing the Prodesse ProAdeno+ assay, a multiplex real-time polymerase chain reaction (PCR) in-vitro diagnostic (IVD) test for the qualitative detection of human adenovirus.
The ProAdeno+ assay uses real-time PCR to qualitatively detect human adenovirus DNA in nasopharyngeal specimens obtained from people exhibiting signs and symptoms of acute respiratory infection.
The test is intended for use to aid in the diagnosis of human adenovirus infection and detects adenovirus serotypes 1-51 without differentiation, but the test results can be obtained in as little as three hours.
Gen-Probe Gen-Prodesse business corporate strategy and marketing senior vice president and general manager Eric Tardif said FDA clearance of their ProAdeno+ assay adds to the Prodesse portfolio of molecular tests for respiratory infectious diseases.
"The people most susceptible to complications from adenovirus infections include pediatric and elderly populations and our assay will be an important tool to help physicians diagnose this disease," Tardif said.
Gen-Probe said the ProAdeno+ assay uses the same sample type as Prodesse’s other respiratory infectious disease tests, so a single sample can be tested with any combination of the products and all Prodesse assays are simple to use and easily integrate into a lab’s existing workflow.