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Gen-Probe Gets FDA OK for Human Adenovirus Test

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Gen-Probe said after the close of the market Wednesday that its Prodesse subsidiary has received US Food and Drug Administration clearance for its ProAdeno+ assay for qualitative detection of human adenovirus.

The test uses real-time PCR to detect human adenovirus DNA in nasopharyngeal specimens obtained from people exhibiting signs and symptoms of acute respiratory infection. It can detect but not differentiate among adenovirus serotypes 1-51, said Gen-Probe.

Though adenoviruses most commonly cause respiratory disease, depending on the serotype, they may also cause other illnesses, such as gastroenteritis, conjunctivitis, bladder infection, and rash illness, the firm said.

Gen-Probe noted that the test is the third Prodesse product cleared by FDA since Gen-Probe acquired the firm a little more than a year ago.

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