Health Canada grants medical device licence to Gen-Probe's PANTHER system

Gen-Probe Incorporated (NASDAQ: GPRO) announced today that Health Canada has granted the Company a medical device license for the PANTHER® system, a fully automated and integrated molecular testing system designed with the flexibility to handle a wide range of testing needs.

The PANTHER system may be used to run the APTIMA Combo 2® assay, Gen-Probe's market-leading dual test for the common sexually transmitted infections Chlamydia and gonorrhea.

"Receiving a Canadian regulatory license for the PANTHER system is another important milestone in our efforts to create differentiated value for our laboratory customers around the world," said Carl Hull, Gen-Probe's president and chief executive officer. "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 addition to the APTIMA Combo 2 assay, Gen-Probe is developing several other qualitative and quantitative assays for the PANTHER system. Over time, these new assays will enable customers to increase efficiency by consolidating testing on the system.

Key features of the PANTHER system include: -- Fully integrated "sample-in, result-out" automation. A single operator can process 275 samples in eight hours on the PANTHER system, yielding a total of 550 Chlamydia and gonorrhea results with the APTIMA Combo 2 assay. Hands-on time is less than 30 minutes, resulting in more than seven hours of walk-away freedom. For larger customers, the PANTHER system can continue running unattended, processing 500 samples (1,000 total Chlamydia and gonorrhea results) in 12 hours. These automation features can help laboratory customers manage chronic labor shortages. -- Primary tube sampling with random access loading for maximum flexibility and productivity. Multiple assays can be run from a single sample, and operators have continuous access to samples, reagents and consumables. -- A customer-driven design, intuitive software for ease of use, and remote diagnostics capabilities. To increase lab efficiency further, PANTHER comes with a bi-directional host interface for automatic download of sample test requests. -- Extensive process controls that include positive sample identification, liquid level detection, reagent dispense verification, and radio frequency identification (RFID) tags on fluid containers. These controls help reduce the potential for manual errors. -- A small footprint with a width of 48", a depth of 32", and a height of 69".

The PANTHER system complements Gen-Probe's TIGRIS® system, which was the first fully automated, high-throughput molecular testing system for large laboratories. Since its launch in 2004, more than 550 TIGRIS systems have been installed at high-volume clinical diagnostic and blood screening laboratories around the world. TIGRIS can process up to 1,000 patient samples in a day, yielding 2,000 Chlamydia and gonorrhea results with the APTIMA Combo 2 assay.

The PANTHER system was CE-marked for sale in the European Union late in 2010. A regulatory application for the PANTHER system has been submitted to the US Food and Drug Administration, but the system has not been cleared for marketing in the United States.