This article is more than 5 years old. Information may no longer be current.

FDA cleared marketing of human adenovirus diagnostic test

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

The FDA has cleared marketing of a multiplex real-time polymerase chain reaction in vitro diagnostic test for the detection of human adenovirus, according to a press release.

The Prodesse ProAdeno assay — manufactured by Gen-Probe Inc. — utilizes real-time polymerase chain reaction (PCR) to detect human adenovirus DNA in nasopharyngeal specimens pooled from people who exhibit signs and symptoms of acute respiratory infection, according to the release.

The test detects, but does not distinguish among serotypes 1-51. Test results can be obtained in as little as 3 hours.

The 510(k) application for the assay was one of five US regulatory submissions by Gen-Probe during 2010. In addition, the assay is the third Prodesse product cleared by the FDA since Gen-Probe acquired Prodesse nearly 1 year ago.

Follow InfectiousDiseaseNews.com on Twitter.