Cepheid CPHD today
announced that it has received clearance from the U.S. Food & Drug
Administration (FDA) to market Xpert^® CT/NG. Running on Cepheid's GeneXpert^®
Systems, Xpert CT/NG is a qualitative in vitro molecular diagnostic test for
the detection and differentiation of Chlamydia trachomatis (CT) and Neisseria
gonorrhoeae (NG). For the first time, same-day patient consultation and
treatment is possible for the two most common sexually transmitted bacterial
infections in the United States.
"We are bringing to market a true next-generation molecular diagnostic product
for detection of CT/NG — a test we designed from the ground up to provide
accuracy, ease of use, and results availability," said John Bishop, Cepheid's
Chief Executive Officer. "We expect this innovative diagnostic test to deliver
new levels of confidence to clinicians, in addition to enabling same-day
decisions about treating their patients — the critical first step in
effectively managing these epidemics."
"An on-demand test capable of delivering accurate results while patients are
still present in the clinic provides a much-needed advantage in our efforts to
control infectious diseases such as chlamydia and gonorrhea. Delays in
treatment can lead to complications in about 1 in 25 infected women awaiting
test results," said Dr. Edward Hook, MD, Professor of Medicine and
Epidemiology at the University of Alabama, Birmingham, and Director of the STD
Control Program for the Jefferson County Department of Health. "In addition,
the availability of results in less than 90 minutes is especially important
for patients presenting to Emergency Departments and in managing patients who
may not return for treatment."
Based on Cepheid's unique experience with the biothreat detection program,
where more than 11 million tests have been performed, the Company has learned
that the best way to minimize gonorrhea false positive results is to include
more than one genetic target.
"Xpert CT/NG incorporates several novel design features. First, our research
team used in silico approaches to uncover multiple genomic targets for
improving the accuracy of both CT and NG detection. Second, we included a
first-in-class sample adequacy control that we believe overcomes limitations
of first-generation technologies and adds significantly to the interpretation
of diagnostic results generated by the GeneXpert System," said David Persing,
MD, Ph.D., Cepheid's Chief Medical and Technology Officer. "Xpert CT/NG is
clearly the most sophisticated test in its class, yet it can be performed
on-demand by virtually any laboratory in order to maximize the medical impact
of the results."
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