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Canada Approves Gen-Probe's Panther Molecular Testing System

NEW YORK (GenomeWeb News) – Gen-Probe announced on Monday that its Panther molecular testing system has received clearance from Canadian regulators for marketing there.

The granting of the medical device license from Health Canada follows CE marking for the system in late 2010. The San Diego-based company filed for approval of the platform with the US Food and Drug Administration in the spring and hopes for approval by the end of the year or in early 2012.

Panther is a fully automated and integrated molecular testing system which complements Gen-Probe's Tigris system. Approval by Health Canada means the Panther system can be used to run the Aptima Combo 2 assay for chlamydia and gonorrhea, and in a statement Gen-Probe said it is developing several other qualitative and quantitative assays for the system.

At an investor conference in June, Gen-Probe CFO Herm Rosenman said that the planned test menu for Panther includes assays for human papillomavirus, hepatitis C virus, chlamydia, gonorrhea, and HIV. The company also intends to reformulate its PCA3 prostate cancer test for the Panther and to develop a test for trichomonas for the platform.

Last week Health Canada approved Gen-Probe's Progensa PCA3 assay for prostate cancer.

In a statement on Monday, Gen-Probe CEO Carl Hull said, "We believe the Panther system will revolutionize molecular diagnostics by offering customers high levels of productivity and instrument flexibility that were once reserved for high-throughput clinical chemistry and immunoassay systems."

In a research note, Raymond James analyst Nicholas Jansen today said that initial adoption of the platform in Europe has been "favorable and consistent with expectations, with management still targeting a few dozen placements in 2011." He added that 60 percent of overseas placements have been competitive takeaways, which "highlight the favorable attributes that Panther brings to the table relative to existing products on the market."

Panther, he said, will ultimately drive growth from menu expansion and consolidate testing on a single platform, increasing access to global markets and providing full automation to customers.