SpeeDx Receives FDA Breakthrough Designation for ResistancePlus® GC
Ltd. announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for ResistancePlus GC* - expediting the path towards FDA clearance.
SpeeDx Pty. Ltd. announced today that the U.S. Food and Drug
Administration (FDA) has granted Breakthrough Device designation for ResistancePlus®
GC* - expediting the path towards FDA clearance. ResistancePlus®
GC is the first commercially available molecular test providing
ciprofloxacin susceptibility and resistance information to effectively
treat the sexually transmitted infection (STI) N. gonorrhea.
It is already CE-marked and cleared by the Therapeutic Goods Association
(TGA) for use across Europe, Australia and New Zealand. It detects both
the sexually transmitted infection N. gonorrhea and sequences in
the gyrA gene of the bacteria associated with susceptibility or
resistance to ciprofloxacin, a previously used front-line antibiotic
treatment.
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Results from ResistancePlus GC can be used to guide treatment decisions for gonorrhea infections, giving doctors and patients the option of using a simple oral dose of ciprofloxacin instead of ceftriaxone, one of the last remaining antibiotics available for multi-drug resistant infections. (Photo: Business Wire)
Results from the test can be used to guide treatment decisions for
gonorrhea infections, giving doctors and patients the option of using
ciprofloxacin instead of ceftriaxone, one of the last remaining
antibiotics available for multi-drug resistant infections.
“There is an urgent need for better diagnostics to address the problem
of drug-resistant gonorrhea in the United States,” said Dr. Jeffrey
Klausner, Professor of Medicine and Public Health at David Geffen School
of Medicine and Fielding School of Public Health, University of
California, Los Angeles. “Drug-resistant gonorrhea is an urgent public
health problem.”
The FDA Breakthrough Devices Program is intended to help patients have
more timely access to medical devices that provide for more effective
treatment or diagnosis of life-threatening or irreversibly debilitating
diseases by expediting their development, assessment, and review.
“We are very pleased that the FDA has recognised ResistancePlus
GC as an important tool for the ongoing arms race against gonorrhea and
rising antibiotic resistance,” said Colin Denver, SpeeDx CEO. “The
results from our tests empower clinicians to make better informed
treatment decisions, and we are passionate about the responsible use and
stewardship of antibiotics to achieve the best possible patient
outcomes.”
Ceftriaxone, a painful intramuscular injection, is the current
front-line treatment for gonorrhea, however resistance has already been
reported in Europe and Australia1,2 and experts are concerned
that we may quickly run out of treatment options altogether.3
Recent surveillance data indicates that in some regions up to 7 out of
10 infections could be effectively treated with a single, more
convenient oral dose of ciprofloxacin if the susceptibility status is
established prior to prescribing.4-6 The British Association
of Sexual Health and HIV (BASHH) have recognised the importance of
antibiotic stewardship in their recently updated gonorrhea management
guidelines, preferring the use of ciprofloxacin over ceftriaxone if
antibiotic susceptibility results are available prior to treatment.7
“SpeeDx tests can help make antibiotic-resistance guided therapy a
reality, giving doctors real time information to make smarter antibiotic
treatment choices,” adds Dr. Klausner.
Besides developing antibiotic resistance testing for gonorrhea, SpeeDx
is also conducting multi-site clinical trials for the ResistancePlus®
MG test (not currently available for sale in the U.S.). The molecular
test detects the rapidly rising STI Mycoplasma genitalium, also
known as Mgen, along with genetic markers linked to antibiotic resistance.
In recent years, Mgen prevalence has increased globally and developed
high rates of resistance to the frontline antibiotic treatment,
azithromycin.
*Not available in the U.S.
About SpeeDx
Founded in 2009, SpeeDx is an Australian-based
private company with offices in London and the US, and distributors
across Europe. SpeeDx specializes in molecular diagnostic solutions that
go beyond simple detection to offer comprehensive information for
improved patient management. Innovative real-time polymerase chain
reaction (qPCR) technology has driven market-leading multiplex detection
and priming strategies. Product portfolios focus on multiplex
diagnostics for sexually transmitted infection (STI), antibiotic
resistance markers, and respiratory disease. For more information on
SpeeDx please see https://plexpcr.com.
References
1. PHE Health Protection Report Volume 12, Number 11. 2018
2. AU
DoH Media Statement April 17th 2018.
3. Unemo, M. & Jensen, J.S.
2016. Nat. Rev. Urol..268. Published online 10 Jan 2017.
doi:10.1038/nrurol
4. Eyre DW et al. Euro Surveill. 2019;24(10):
pii=1900147.
5. Harris SR et al. Lancet Infect Dis Published online
May 15th, 2018
6. Lahra MM et al. Australian Gonococcal
Surveillance Programme annual report, 2015
7. Fifer et al. British
Association for Sexual Health and HIV national guideline for the
management of infection with Neisseria gonorrhoeae (2019).
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