FDA Approves Prodesse ProAdeno™+ Adenovirus Assay

The FDA has cleared for marketing the Prodesse ProAdeno™+ assay, a multiplex real-time PCR in vitro diagnostic test for the qualitative detection of human adenovirus. 'FDA clearance of our ProAdeno+ assay adds to the Prodesse portfolio of molecular tests for respiratory infectious diseases,' said Eric Tardif, Gen-Probe's senior vice president of corporate strategy and marketing, and general manager of Gen-Probe's Prodesse business.

'The people most susceptible to complications from adenovirus infections include pediatric and elderly populations. Our assay will be an important tool to help physicians diagnose this disease.' The 510(k) application for the ProAdeno+ assay was one of five US regulatory submissions by Gen-Probe in 2010. In addition, the ProAdeno+ assay is the third Prodesse product cleared by the FDA since Gen-Probe acquired Prodesse approximately one year ago.

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. It detects, but does not differentiate among, adenovirus serotypes 1-51.

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 these products. All Prodesse assays are simple to use and easily integrate into a lab's existing workflow. They have been optimized for use with automated extraction technology to minimize technician hands-on time. Test results can be obtained in as little as three hours, a significant improvement over culture-based methods that can take up to weeks to produce a result.