Diagnostic-test maker Gen-Probe (GPRO) - Get GoPro, Inc. Class A Report said Wednesday it received a marketing approval from the U.S. Food and Drug Administration for its Procleix Ultrio Assay to run on the enhanced semi-automated Procleix System.
The Procleix Ultrio Assay was approved to screen donated blood, plasma, organs and tissue for HIV-1 and hepatitis C virus in individual blood donations or in pools of up to 16 blood samples, and to detect the presence of hepatitis B virus.
The San Diego, Calif.-based company said that early in the first quarter of 2007 it plans to submit the regulatory application to FDA for approval to run the test on the fully automated, high-throughput Procleix Tigris System.
Earlier Wednesday, Gen-Probe was upgraded from neutral to outperform at Robert Baird, which set a $55 price target.
Shares of Gen-Probe rose $3.14, or 7.1%, to close at $47.62 Wednesday.
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