(By Balachander) Gen-Probe Inc. (NASDAQ:GPRO), a manufacturer of molecular diagnostic products, announced approval from the U.S. health regulators for the company's PANTHER testing system.
The San Diego, California-based company's PANTHER system fully automates all aspects of nucleic acid testing (NAT) on a single, integrated platform, according to the company Web site.
The PANTHER system can initially be used to test for the common sexually transmitted infections Chlamydia trachomatis and Neisseria gonorrhoeae with the APTIMA Combo 2 assay, the company said.
Gen-Probe said the approval from the U.S. Food and Drug Administration (FDA) will significantly increase its addressable market domestically, following on the successful international launch of PANTHER in late 2010.
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The PANTHER system builds on the success of Gen-Probe's TIGRIS instrument, a NAT system for diagnostics and blood screening.
"The unique capabilities of future versions of the PANTHER system will provide Gen-Probe with the opportunity to enter new and attractive markets in the future such as viral load testing," Gen-Probe said in a statement.
The company will commence shipments of PANTHER systems to US customers during the second quarter of 2012.
GRPO shares closed Monday's regular trading at $81.39. Over the past year, the stock has been trading between $53.92 and $86.96.