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‘/>”/>
