Gen-Probe Files for US Regulatory Clearance of PANTHERâ„¢ System, Fully Automated and Integrated Molecular Testing Instrument
SAN DIEGO, May 20, 2011 /PRNewswire/ -- 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 man