SAN DIEGO, May 8, 2012 /PRNewswire/ -- Gen-Probe
Incorporated (NASDAQ: GPRO) 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.
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"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.
About Gen-Probe
Gen-Probe is a global leader in the development, manufacture and
marketing of rapid, accurate and cost-effective molecular
diagnostic products and services that are used primarily to
diagnose human diseases, screen donated human blood, and ensure
transplant compatibility. Gen-Probe is headquartered in
San Diego and employs
approximately 1,400 people. For more information, go to
http://www.gen-probe.com.
Caution Regarding Forward-Looking Statements
Any statements in this news release about our expectations,
beliefs, plans, objectives, assumptions or future events or
performance are forward-looking statements. These statements
are often made through the use of words or phrases such as believe,
will, expect, anticipate, estimate, intend, plan and would.
For example, statements concerning possible or expected results of
operations, regulatory approvals, the development and
commercialization of new products, future sales and product menu
offerings, growth opportunities, and plans of management are all
forward-looking statements. Forward-looking statements are
not guarantees of performance. They involve known and unknown
risks, uncertainties and assumptions that may cause actual results
to differ materially from those expressed or implied. Some of
these risks include: (i) the risk that other assays will not be
approved for use on the PANTHER system; (ii) the possibility that
the market for the sale of our PANTHER system or other new products
may not develop as expected; (iii) the risk that our intellectual
property surrounding the PANTHER system will be invalidated; and
(iv) the risk that we may not be able to compete effectively.
This list includes some, but not all, of the factors that could
affect our ability to achieve results described in any
forward-looking statements. For additional information about
risks and uncertainties we face and a discussion of our financial
statements and footnotes, see documents we file with the SEC.
We assume no obligation and expressly disclaim any duty to update
forward-looking statements to reflect events or circumstances after
the date of this news release or to reflect the occurrence of
subsequent events.
Contact:
Al Kildani
Sr. director, investor relations and
corporate communications
858-410-8653
SOURCE Gen-Probe Incorporated