Gen-Probe seeks FDA regulatory clearance for PANTHER fully automated and integrated molecular testing system

May 20 2011

Gen-Probe Incorporated (NASDAQ: GPRO) announced today that the Company has filed a 510(k) application with the US Food and Drug Administration for its PANTHER™ system, a fully automated and integrated molecular testing system designed with the flexibility to handle a wide range of testing needs.

"Filing our US regulatory application for the PANTHER system on-time is another important milestone in our efforts to create differentiated value for our laboratory customers," 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."

Gen-Probe filed for regulatory clearance to run the APTIMA Combo 2® assay, the Company's market-leading dual test for the common sexually transmitted infections Chlamydia and gonorrhea, on the PANTHER system.  Several other qualitative and quantitative assays are being developed for the system.  Over time, these new assays will enable customers to increase efficiency by consolidating testing on the PANTHER platform.

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 550 Chlamydia and gonorrhea results with the APTIMA Combo 2 assay.  Hands-on time is less than an hour, 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 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.
• 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 as many as 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.