Gen-Probe Receives FDA Approval -- Stock
Has Risen 211%
01/02/04
Gen-Probe, up 210.7% since our buy signal last January, on
Monday received FDA approval for its innovative system designed
to improve workflow and increase productivity for clinical
labs. After the news was released, the stock shot up 12.6%.
Gen-Probe Inc. (ticker: GPRO) manufactures
testing products used for the diagnosis of diseases and screening
of donated human blood. If you missed out on our recommendation
to buy Gen-Probe and the subsequent 211% jump in its price,
then subscribe
today.
More information about the FDA approval
follows:
Gen-Probe Receives FDA Approval for STD
Testing on the TIGRIS® DTS™ System
SAN DIEGO, CA, December 29 -- Gen-Probe
Incorporated (Nasdaq: GPRO) announced today that the U.S.
Food and Drug Administration (FDA) has granted marketing clearance
for sexually transmitted disease testing on the company’s
TIGRIS® DTS(TM) System, the first fully automated, high
throughput instrument for the molecular diagnostics marketplace.
The TIGRIS System has been approved to run Gen-Probe’s APTIMA
COMBO 2® assay, an FDA-approved amplified nucleic acid
test (NAT) for simultaneously detecting Chlamydia trachomatis
and Neisseria gonorrhoeae.
“FDA clearance of our revolutionary TIGRIS
System with the APTIMA COMBO 2 assay represents another first
for Gen-Probe and for the molecular diagnostics industry that
will significantly improve the efficiency of testing for sexually
transmitted diseases,” said Henry L. Nordhoff, chairman, president
and chief executive officer of Gen-Probe. “We have delivered
on our goal to lead the development of higher throughput,
fully automated systems that can improve workflow and reduce
laboratory costs. Now we will focus on expanding the menu
of clinical diagnostic and blood screening tests that can
be performed on the TIGRIS System.”
The TIGRIS System, which is intended initially
for clinical diagnostics and later for blood screening laboratories,
is the first diagnostic instrument to truly automate NAT testing
from start to finish. For example, no manual sample preparation
is required to initiate a run and generate test results. The
TIGRIS System is expected to significantly reduce labor costs,
minimize testing errors, improve operator ergonomics and increase
laboratory productivity.
“We were very impressed with the performance
of the TIGRIS System during our clinical evaluation,” said
Edward W. Hook III, M.D., professor of medicine and epidemiology
at the University of Alabama at Birmingham (UAB) and director
of UAB’s center for social medicine and STDs. “The combination
of the TIGRIS instrument and the APTIMA COMBO 2 assay provided
outstanding sensitivity and specificity that was equivalent
to the semi-automated system. At the same time, however, the
TIGRIS System was much easier to use and dramatically increased
productivity and testing throughput.”
Clinical laboratories in the United States
are facing serious shortages of skilled technical labor, with
vacancy rates for laboratory positions at a 12-year high.
The scarcity of trained technicians, combined with the challenges
of keeping up with new testing technologies, have led both
large and small laboratories to increasingly seek out automated
solutions that increase productivity, reduce costs and ensure
that accurate results are produced in time to improve patient
care.
The TIGRIS System has the ability to process
approximately 500 samples in an eight-hour shift and up to
1,000 samples in approximately 13 hours. Because one trained
operator can run two or three TIGRIS machines simultaneously,
the productivity of a single technician using the TIGRIS System
could be as much as 10 times greater than a technician using
current semi-automated systems.
In mid-2003, Gen-Probe conducted a clinical
evaluation that demonstrated agreement between results on
the TIGRIS System and Gen-Probe’s existing semi-automated
system using the APTIMA COMBO 2 assay. Gen-Probe announced
on July 18, 2003 that it had filed its FDA Pre-market Notification,
also called a 510(k) application, ahead of schedule, for U.S.
marketing clearance for STD testing on the TIGRIS System.
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