), a leading diagnostic devices company, recently announced the
approval of the U.S. Food and Drug Administration ("FDA") for its
PANTHER system, an immunoassay instrument for molecular diagnosis.
The system has been given the initial approval to be used with its
market-leading chlamydia and gonorrhea test APTIMA COMBO 2.
The PANTHER system can process a number of different molecular
tests as well as generate results on all phases of nucleic acid
testing ("NAT") on a single platform, with minimal human
interference. The instrument can process roughly 275 tests in 8
hours and about 500 tests in 12 hours. The device, with its high
level of automation, is expected to replace a full day's laboratory
work with 4 hours of labor-free result processing.
The California-based company had filed a 510(k) approval to the
FDA some time in May 2011. It received the European CE mark for the
instrument in December 2010 and the Canadian approval in August
2011. With the U.S. clearance, a vital milestone has been achieved
in the company's endeavor to make this breakthrough product
available to the global blood screening market.
Gen-Probe has developed several assays designed to run on the
PANTHER system. The PANTHER along with the TIGRIS system are among
the most important devices in the company's product portfolio.
Gen-Probe's revenues rose 7% year over year to $153.4 million in
the most recent quarter. Product sales increased 9% to $150.1
million as healthy sales across Blood Screening and Clinical
Diagnostics franchises was partially offset by lower revenues from
the Research Products and Services and Collaborative Research
businesses. Revenues from Collaborative Research plunged 61% to
$1.4 million, hurt by lower funding from
) for the development of the PANTHER system for blood
Gen-Probe is a dominant player in the rapidly expanding NAT
market, the fastest growing segment in the clinical diagnostic
market. It is a market leader in domestic gonorrhea and chlamydia
testing with its PACE and APTIMA assay product lines. Gen-Probe
competes with more established firms in the molecular diagnostic
industry such as
Currently, we have a long-term Neutral recommendation on
Gen-Probe, which is in tandem with a short-term Zacks #3 Rank
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