SpeeDx Receives CE-IVD Mark for ResistancePlus® GC Gonorrhea Test
New molecular assay enables rapid antibiotic resistance result to support use of cost effective and convenient oral antibiotic for gonorrhea treatment
SYDNEY, Australia, Dec. 06, 2018 (GLOBE NEWSWIRE) -- SpeeDx Pty. Ltd. announced today it has received CE-IVD marking for its
® GC assay that detects both the sexually transmitted infection (STI) N. gonorrhoeae, and sequences in the gyrA gene of the bacteria associated with susceptibility to ciprofloxacin (Cipro), a previously used front-line antibiotic treatment. Currently, ceftriaxone ̶ a painful intramuscular injection ̶ combined with azithromycin, is the front-line treatment for gonorrhea in the U.S. However, ceftriaxone represents one of the last remaining antibiotics used for multi-drug-resistant infections and needs to be utilized sparingly so as not to increase resistance to the drug. Already, there are strains of gonorrhea that are resistant to this treatment.
SpeeDx’s new test will allow doctors to confidently and cost-effectively treat up to 70% of gonorrhea infections with a single oral dose of ciprofloxacin because the test establishes disease susceptibility to ciprofloxacin prior to prescribing.
"The ResistancePlus GC test is the first innovation in gonorrhea treatment in decades,” 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. “With the continued spread of multi-drug gonorrhea, this test can make a real difference.”
Recent surveillance data shows that susceptibility to ciprofloxacin is as high as 70% in some regions and greater than 50% across the majority of countries contributing surveillance data.1-4 In response to the clear utility of ciprofloxacin, the British Association of Sexual Health and HIV (BASHH) have recently drafted new gonorrhea management guidelines that include the preferential use of ciprofloxacin over ceftriaxone if antimicrobial susceptibility testing results are available prior to treatment.5
“We used a similar test at UCLA in Los Angeles and found that doctors liked the test and were much more likely to prescribe a safer and simpler medicine like oral Cipro tablets instead of using injections like Ceftriaxone,” reports Dr. Klausner.
“ResistancePlus GC is an important next step in our ResistancePlus portfolio and is a welcome addition in managing the extensive antibiotic resistance in N. gonorrhoeae infections,” said Colin Denver, CEO for SpeeDx. “We are already seeing high interest in this test with its clear role in maintaining stewardship of the limited antibiotics still available to treat gonorrhea.”
Resistance Plus GC is the first commercially available molecular test* providing ciprofloxacin susceptibility information and is well placed to support current laboratory molecular testing workflows. “If more doctors use the ResistancePlus GC assay, patients will have a better choice when it comes to treatment and we might make a big difference in controlling antibiotic resistant gonorrhea,” adds Dr. Klausner. “Untreatable gonorrhea is a real threat ̶ use of the ResistancePlus GC assay might stop that.''
*available where CE-mark is accepted, not available in the U.S. or A.U.
N. gonorrhoeae is a bacterium causing gonorrhea, a sexually transmitted infection most frequently causing urethritis in men and cervicitis in women. Gonorrhea can result in infertility or ectopic pregnancy and also increases the risk of acquiring other STIs, including HIV. Transmission from infected mothers to newborns during birth can result in gonococcal conjunctivitis, an infection in the eye (ophthalmia neonatorum).
Prevalence and incidence rates of gonorrhea have been increasing around the world, with corresponding increasing rates of resistance to commonly used antibiotics.6 Recent studies suggest N. gonorrhoeae is threatening to become untreatable as resistance continues to develop against all known antibiotic treatments.6 The currently recommended front-line treatment, ceftriaxone, is the last known effective antibiotic, and several extensively drug resistant strains have now been isolated exhibiting resistance to this and many other available treatments.7,8 Global management strategies for antimicrobial resistance highlight gonorrhea as a priority infection to manage, with more effective use of diagnostic tools listed as a key focus for future development.9
Resistance Plus ® kits are multiplex qPCR tests for detection of infectious diseases and antibiotic resistance markers, respectively. Powered by proprietary Plex Zyme ® and Plex Prime ® technologies, the product line offers high multiplexing capability for better, more streamlined infectious disease management. ResistancePlus test offer more than detection, supporting resistance guided therapy by providing actionable information for laboratories and clinicians alike.
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
1. Harris SR et al. Lancet Infect Dis Published online May 15th 2018.
2. Lahra MM et al. Australian Gonococcal Surveillance Programme annual report, 2015
3.Heffernan H et al. Antimicrobial resistance and molecular epidemiology of gonococci in NZ, 2014-5
4. Kirkcaldy RD et al. MMWR Surveillance Summaries July 15, 2016 / 65(7);1–19
5. Fifer H. et al. 2018 UK national guideline for the management of infection with Neisseria gonorrhoeae (Draft).
6. Unemo, M. & Jensen, J.S. 2016. Nat. Rev. Urol..268. Published online 10 Jan 2017. doi:10.1038/nrurol
7. PHE Health Protection Report Volume 12, Number 11. 2018
8. AU DoH Media Statement April17th 2018.
9. Rapid Risk Assessment 7 May 2018. Stockholm: ECDC; 2018.
|Asia Pacific and Europe||United States|
|Global Marketing Manager||RCI Healthcare Public Relations|
|Madeline O’Donoghue||Rick Roose|
|+61 2 9209 4170||+1 415 202 4445|
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Følg saker fra GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra GlobeNewswire
Align Technology Launches New iTero Element 5D Imaging System for Comprehensive Preventative and Restorative Oral Care at IDS18.2.2019 12:00:00 | Pressemelding
SAN JOSE, Calif., Feb. 18, 2019 (GLOBE NEWSWIRE) -- First intraoral scanner with near-infrared imaging (NIRI) technology that scans the internal structure of a tooth (enamel & dentin) in real time1. First integrated dental imaging system that simultaneously records 3D, intra-oral color and NIRI, and enables comparison over time using iTero® TimeLapse1. NIRI technology of the iTero Element® 5D system aids in detection and monitoring of interproximal caries lesions above the gingiva without using harmful radiation1. New web-based interface MyiTero.com complements visualization of the iTero Element 5D system. Limited-release direct doctor-lab workflow automatically sends scan to lab of choice. Align Technology, Inc. (NASDAQ: ALGN) today announced that it is launching the iTero Element 5D Imaging System, which provides a new comprehensive approach to clinical applications, workflows and user experience that expands the suite of existing high-precision, full-color imaging and fast scan time
General Electric Company: Dividend Declaration18.2.2019 08:00:00 | Pressemelding
FAIRFIELD, Conn., Feb. 18, 2019 (GLOBE NEWSWIRE) -- GE Board of Directors Authorizes Regular Quarterly Dividend The Board of Directors of GE (NYSE: GE) today declared a $0.01 per share dividend on the outstanding common stock of the Company. The dividend is payable April 25, 2019 to shareowners of record at the close of business on March 11, 2019. The ex-dividend date is March 8, 2019. About GE GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. For more than 125 years, GE has invented the future of industry, and today it leads new paradigms in additive manufacturing, materials science, and data analytics. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE's mission and deliver for our customers. www.ge.com GE's Investor Relations website at www.ge.com/investor and our corporate b
CTG Promotes Three Long-time Business Leaders in Europe15.2.2019 15:00:00 | Pressemelding
Bob Daelman, Guido Helsloot and Rénald Wauthier named Vice Presidents BUFFALO, N.Y., Feb. 15, 2019 (GLOBE NEWSWIRE) -- CTG (NASDAQ: CTG), a leading provider of information technology (IT) solutions and services in North America and Western Europe, announced today that three of the Company’s high-performing managers in its European business, Bob Daelman, Guido Helsloot and Rénald Wauthier, have each been named vice president. “Bob Daelman and Rénald Wauthier have proven track records of significantly expanding their respective businesses in Europe. Guido Helsloot has been key enabler in effecting two acquisitions in the past six years that expanded our operations and was again instrumental in driving our recent Tech-IT acquisition that will give CTG broader end-to-end capabilities to better-serve our clients. Together, this team has greatly contributed to our success in Europe, where CTG has recorded eight consecutive years of revenue growth,” commented Filip Gydé, current Executive Vic
Jazwares Announces Partnership with Kellytoy for Russ Berrie™ Worldwide15.2.2019 01:00:00 | Pressemelding
Sunrise, FL, Feb. 14, 2019 (GLOBE NEWSWIRE) -- Jazwares LLC, a global leader in toys and licensing, announced today that its affiliate Zag Toys, LLC (“Zag Toys”) formed a strategic partnership for their wholly owned brand Russ Berrie™, with Kellytoy, an influential manufacturer and distributor of plush toys and pet products. This relationship will carry on the 50+ year legacy of the Russ Berrie™ brand, positioning it globally as the premier plush brand on retail shelves in Fall 2019. Kellytoy will market the Russ Berrie™ brand through its global distribution channels, which include almost every market segment. “Working together with Kellytoy will maximize the Russ Berrie™ legacy,” says Judd Zebersky, Jazwares CEO and President. “By leveraging Russ Berrie™ and its reputation for quality and commitment to “Make Someone Happy™” with Kellytoy’s global footprint we’ll secure placement in retailers all around the world, putting Russ Berrie™ at the forefront of today’s plush presence at retai
PROFEPA report confirms no contamination of soil from overflow of contingency pond at the San Jose Mine, Mexico in October 201814.2.2019 19:46:00 | Pressemelding
VANCOUVER, British Columbia, Feb. 14, 2019 (GLOBE NEWSWIRE) -- Fortuna Silver Mines Inc. (NYSE: FSM) (TSX: FVI) is pleased to report that the Federal Attorney's Office for Environmental Protection (PROFEPA) has completed its investigation into the overflow of the contingency pond at the dry stack tailings facility at the San Jose Mine on October 8, 2018, which was caused by heavy seasonal rains (refer to Fortuna news release dated October 11, 2018). PROFEPA’s final report confirms that the overflow did not contaminate soil, and therefore no remediation is required. The Company awaits a final report from the Mexican National Water Commission (CONAGUA). The Company reiterates its commitment to safeguarding the wellbeing of the environment, local communities and our work force. About Fortuna Silver Mines Inc. Fortuna is a growth oriented, precious metals producer focused on mining opportunities in Latin America. Our primary assets are the Caylloma silver Mine in southern Peru, the San Jos
Cloudian HyperStore Named 2018 Product of the Year in Software-defined and Cloud Storage by Storage Magazine14.2.2019 19:10:00 | Pressemelding
Also Wins Best Hybrid Cloud Solution in 2018-2019 Cloud Awards, Further Reinforcing Company’s Object Storage Leadership SAN MATEO, Calif., Feb. 14, 2019 (GLOBE NEWSWIRE) -- Cloudian today announced two top industry awards for its HyperStore object storage platform. The awards are the latest honors for the company’s limitlessly scalable, highly cost-effective solution, which provides the industry’s best S3 compatibility and seamless data management across on-premises and public cloud environments. 2018 Software-defined and Cloud Storage Product of the Year TechTarget’s Storage magazine and SearchStorage.com named HyperStore 7 as the Gold winner in the Software-defined and Cloud Storage category of the 2018 Products of the Year Awards. The judging panel of analysts, consultants, users and TechTarget writers were “particularly impressed with [HyperStore’s] functionality.” In addition, the solution received high marks for innovation, value and ease of integration, use and manageability, en