Gen-Probe Incorporated announced today that the US Food and Drug Administration (FDA) has cleared its PANTHER system, a fully automated and integrated molecular testing platform designed with the flexibility to handle a wide range of testing needs. 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.
"FDA clearance of our PANTHER system represents a significant milestone for Gen-Probe," said Carl Hull, Gen-Probe's chairman and chief executive officer. "It is a credit to the scores of talented and dedicated scientists and engineers who made it happen. Just as TIGRIS® revolutionized molecular diagnostic screening with an unparalleled level of throughput and automation, we believe PANTHER will continue that revolution by bringing the power of fully-automated, sample-to-result capabilities to low- and medium-volume labs. This clearance will now allow the Company to significantly increase its addressable market domestically, following on the successful international launch of PANTHER in late 2010. 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."
Key features of the PANTHER system include:
Fully integrated "sample-in, results-out" automation. A single operator can process 275 samples in eight hours on the PANTHER system. Hands-on time is less than an hour, yielding seven hours of walk-away freedom per shift. For larger customers, the PANTHER system can continue running unattended, processing up to 500 samples in 12 hours.
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 including positive sample identification, liquid level detection, reagent dispense verification, and radio frequency identification (RFID) tags on fluid containers providing customers confidence in results.
A small footprint and compact profile with a width of 48 inches, a depth of 32 inches, and a height of 69 inches.
Gen-Probe will begin shipments of PANTHER systems to US customers during the second quarter of 2012. Additional APTIMA women's health assays such as APTIMA® Trichomonas vaginalis and APTIMA® HPV are expected to be added to the PANTHER menu as they progress through the regulatory process, and several other qualitative and quantitative assays are currently in development.
The PANTHER system builds on the success of 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 650 TIGRIS systems have been installed at clinical diagnostic and blood screening laboratories around the world.