FDA Approves Gen-Probe's PANTHER - Analyst Blog
May 11 2012 - 8:15AM
Zacks
Gen-Probe Inc.
(GPRO), 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
Novartis (NVS) for the development of the PANTHER
system for blood screening.
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 Roche
(RHHBY), Becton, Dickinson (BDX) and
Abbott Labs (ABT).
Currently, we have a long-term
Neutral recommendation on Gen-Probe, which is in tandem with a
short-term Zacks #3 Rank (Hold).
ABBOTT LABS (ABT): Free Stock Analysis Report
BECTON DICKINSO (BDX): Free Stock Analysis Report
GEN-PROBE INC (GPRO): Free Stock Analysis Report
NOVARTIS AG-ADR (NVS): Free Stock Analysis Report
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