SpeeDx Receives CE-IVD Clearance for ResistancePlus MG FleXible
6.9.2019 09:00:00 EEST | Business Wire | Press release
SpeeDx Pty, Ltd. today announced Resistance Plus® MG FleXible for the Cepheid GeneXpert® System, detecting the sexually transmitted infection (STI) Mycoplasma genitalium (Mgen) and markers associated with azithromycin resistance, received CE-IVD mark for sale in Europe. This is the first test to be launched under Cepheid’s FleXible Cartridge programme, partnering with SpeeDx – a trusted assay manufacturer – to provide access to the GeneXpert sample-to-answer FleXible cartridge.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190905006074/en/
ResistancePlus MG FleXible simultaneously detects M. genitalium (Mgen) and macrolide resistance. SpeeDx, a trusted assay manufacturer, has partnered with Cepheid to provide Resistance Guided Therapy for Mgen on the GeneXpert sample-to-answer FleXible cartridge. (Photo: Business Wire)
“ResistancePlus MG FleXible represents both an evolution of our technology and of Resistance Guided Therapy for Mgen”, said Colin Denver SpeeDx CEO. “There is considerable interest by clinicians and laboratories alike, as it will now be even easier to adhere to international and local management guidelines and provide clinically relevant and timely information to manage the growing problem of macrolide resistance in Mgen infections.”
Mgen can cause symptoms such as urethritis, cervicitis, endometritis and pelvic inflammatory disease, and has been linked to reproductive health complications including pre-term birth and infertility.1,2 Macrolide antibiotics, specifically azithromycin, are the first-line treatment for the rapidly growing problem of Mgen, but resistance to these antibiotics has increased up to 50% in several countries.4-6 There are limited alternative treatment options, many of which are expensive, difficult to access, or associated with undesirable side-effects.4,5 Current Mgen guidelines focus on extending the utility of azithromycin by testing for macrolide resistance-associated mutations and stratifying patient treatment accordingly.1-3
“SpeeDx offers unique technology for simultaneous detection of pathogens and drug resistance directly from clinical specimens. Together, we have leveraged the open architecture of our new FleXible cartridge to enable detection of this emerging drug-resistant pathogen on the GeneXpert System,” said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. “The ResistancePlus MG Flexible cartridge offers best-in-class performance in an easy to use, on-demand format to address a significant medical need in symptomatic individuals, and adds to the growing portfolio of STI testing options available on our platform.”
Timely detection of antibiotic resistant infections enables Resistance Guided Therapy, resulting in better treatment of the disease for patients, reduced potential for spreading infection among vulnerable populations, and supporting antibiotic stewardship to combat rising antibiotic resistance.
Resistance Plus® MG FleXible will be exclusively distributed by Cepheid.
About SpeeDx
SpeeDx has developed a molecular diagnostics test portfolio, principally for infectious diseases, that provides both identification as well as therapeutic guidance capabilities. The company is based in Australia with offices in Austin and London, and distributors across Europe. SpeeDx specializes in molecular diagnostic solutions that go beyond simple detection to offer comprehensive information for improved patient management. The SpeeDx Resistance Plus® MG open-platform assay is CE marked for sale in Europe, TGA approved for sale in Australia and clinical trials are being finalised for submission to the U.S. FDA. Products in the SpeeDx portfolio 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
- Jensen JS, Cusini M, Gomberg M, Moi H. 2016. 2016 European guideline on Mycoplasma genitalium infections. J Eur Acad Dermatol Venereol. PMID: 27505296.
- https://www.bashhguidelines.org/media/1146/ngu-update-05_2017-final.pdf
- http://www.sti.guidelines.org.au/sexually-transmissible-infections/mycoplasma-genitalium
- Read T R H, Fairley C K, Murray G L, et al. Outcomes of resistance-guided sequential treatment of Mycoplasma genitalium infections: a prospective evaluation, Clinical Infectious Diseases, ciy477, https://doi.org/10.1093/cid/ciy477
- Getman D, Jiang A, O'Donnell M, Cohen S. 2016. Mycoplasma genitalium prevalence, coinfection, and macrolide antibiotic resistance frequency in a multicenter clinical study cohort in the United States. J Clin Microbiol 54:2278-2283.
- Murray GL, Bradshaw CS, Bissessor M, et al. Increasing Macrolide and Fluoroquinolone Resistance in Mycoplasma genitalium. Emerging Infectious Diseases. 2017;23(5):809-812. doi:10.3201/eid2305.161745.
- Miller WC, Ford CA, Morris M, et al. Prevalence of chlamydial and gonococcal infections among young adults in the United States. JAMA 2004; 291:2229–2236.
- Unemo, M. & Jensen, J.S. ‘Antimicrobial-resistant sexually transmitted infections: gonorrhoea and Mycoplasma genitalium’. 2016. Nat. Rev. Urol.268. Published online 10 Jan 2017. doi:10.1038/nrurol
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190905006074/en/
Contact information
SpeeDx:
Europe, Australia, New Zealand:
Madeline O’Donoghue
+61 2 9209 4170
madelineo@speedx.com.au
USA:
Rick Roose
+1 415.202.4445
roi.roose@gmail.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Align Partners Issues Third Public Shareholder Letter and Submits Formal Shareholder Proposals to Coway14.2.2026 13:31:00 EET | Press release
Align Partners Capital Management Inc. (“Align Partners”), a shareholder of Coway Co., Ltd. (“Coway” or the “Company”), has submitted formal shareholder proposals for the Company’s upcoming 37th Annual General Meeting (“AGM”) and issued its third public shareholder letter to Coway’s Board of Directors. Coway is South Korea’s leading home appliance rental platform, supported by a strong global brand and sales network. Since Netmarble became the largest shareholder in 2020, Coway has delivered steady operating growth, with revenue and operating profit increasing at compound annual rates of 8.9% and 7.7%, respectively, reaching KRW 5.0 trillion in revenue and KRW 878.7 billion in operating profit in 2025. However, Coway’s share price remains materially undervalued, declining 16% from 2019 levels as of February 6, 2026, despite a 155% increase in the KOSPI 200 index over the same period. Over this period, valuation multiples have also compressed significantly, with NTM PER declining from 1
HM King Mohammed VI Presides Over the Launch Ceremony of the Aircraft Landing Gear Production Plant Project, Representing an Investment of €280 million by the Safran Group in Morocco13.2.2026 22:10:00 EET | Press release
His Majesty King Mohammed VI, may God assist Him, accompanied by HRH Crown Prince Moulay El Hassan, chaired on Friday at the Royal Palace in Casablanca the presentation and launch ceremony of the project to build a landing gear production factory for Safran in Nouaceur, a project that reinforces Morocco as a destination of choice and a true integrated industrial actor at the heart of the global economy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213269786/en/ His Majesty King Mohammed VI, accompanied by HRH Crown Prince Moulay El Hassan, chaired on Friday at the Royal Palace in Casablanca the presentation and launch ceremony of the project to build a landing gear production factory for Safran in Nouaceur Considered one of the largest manufacturing centres in the world for Safran Landing Systems, the plant will represent an investment of more than EUR 280 million, create 500 jobs, and operate on 100% decarbonised energ
Sultan bin Ahmed visits Huawei R&D Centre and SMG in China13.2.2026 19:52:00 EET | Press release
His Highness Sheikh Sultan bin Ahmed bin Sultan Al Qasimi, Deputy Ruler of Sharjah and Chairman of the Sharjah Media Council, visited the Huawei Research and Development Centre and Shanghai Media Group (SMG) in Shanghai, People’s Republic of China. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213682693/en/ Sultan bin Ahmed visits Huawei R&D Centre and SMG in China (Photo: AETOSWire) His Highness toured Huawei Village, which spans 2.2 million square metres and comprises over 100 buildings and laboratories, employing more than 30,000 staff. He observed the master plan of the village and its key facilities that support the company’s business strategy and product development. He also reviewed the specifications of the buildings, constructed to the highest standards, and the diverse services provided to employees, including restaurants, cafes, entertainment venues, and rest areas. The center also offers easy access via train
Volue Welcomes TA Associates as New Strategic Investor13.2.2026 12:15:00 EET | Press release
Volue, a global leader in electrification and energy technology, today announced that TA Associates (“TA”), a leading global private equity firm, has joined as a new strategic investor alongside Advent International (“Advent”), Generation Investment Management (“Generation”) and Arendals Fossekompani. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213436945/en/ Over the past 18 months, Volue has undergone a strategic transformation to sharpen its focus on the energy sector. During this period, Volue divested non-core activities and invested in targeted R&D innovation and strategic acquisitions to further position Volue as a leading provider of integrated technology solutions for power trading and generation, grid optimization, and energy market intelligence. Operating at the center of one of the most mission-critical markets of our time, Volue provides technology that enables utilities, grid operators, traders, and energy
ABB strengthens electrical engineering advisory capabilities in Europe with Premium Power acquisition13.2.2026 11:30:00 EET | Press release
ABB today announced it has entered into an agreement to acquire Premium Power, a leading electrical engineering consultancy headquartered near Dublin, Ireland. For more than two decades, Premium Power has established its reputation as a trusted advisor to large customers, particularly in data centers, pharmaceutical manufacturing and other mission-critical sectors where electrical resilience, uptime and regulatory compliance are essential. The transaction is expected to close in the first quarter of 2026. Financial terms were not disclosed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213161407/en/ Paula O'Neill, Managing Director, Premium Power (L) and Owen Flood, Local Division Manager, ABB Electrification Service (R) As demand for electrification accelerates and power systems become more complex due to digitalization, renewable integration and grid constraints, customers increasingly require specialist advisory suppo
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom