European Launch of ResistancePlus MG FleXible for the GeneXpert System
16.12.2019 10:00:00 EET | Business Wire | Press release
SpeeDx Pty, Ltd. today announced the European launch of Resistance Plus® MG FleXible, the first sample-to-answer test for detecting the sexually transmitted infection (STI) Mycoplasma genitalium (Mgen) and markers associated with azithromycin resistance. Cepheid is the exclusive distribution partner of this test, available through Cepheid’s FleXible Cartridge programme for the GeneXpert System.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191215005039/en/
ResistancePlus MG FleXible is now selling in France and the U.K. (to be followed by rest of EU, Australia and New Zealand). This successful collaboration between SpeeDx and Cepheid is the first sample-to-answer test for Mgen and macrolide resistance - exclusively distributed by Cepheid. (Photo: Business Wire)
Management guidelines around the world, including those recently updated in France1 and the U.K.2, reference testing the macrolide resistance status of Mgen infections in order to more effectively treat patients. 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.2,3 Due to the challenges of rising antimicrobial resistance and a lack of clear data that asymptomatic infection leads to protracted health complications, Mgen testing guidelines are unanimous in their recommendation to only test symptomatic individuals.
“This is an important test expansion for the thousands of GeneXpert Systems on the market,” said Colin Denver, SpeeDx CEO. “ Resistance Plus MG FleXible enables Resistance Guided Therapy, supporting more clinicians to adhere to testing guidelines and maximising effective care for their patients infected with Mgen.”
Both SpeeDx and Cepheid will be showcasing Resistance Plus MG at RICAI (Réunion Interdisciplinaire de Chimiothérapie Anti-Infectieuse) December 15th and 16th in Paris. Visit SpeeDx booth #41bis and Cepheid booth #18 to learn more.
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
- https://www.sfdermato.org/site/groupe-infectiologie-dermatologique-et-infections-sexuellement-transmissibles.html
- https://www.bashhguidelines.org/media/1146/ngu-update-05_2017-final.pdf
- http://www.sti.guidelines.org.au/sexually-transmissible-infections/mycoplasma-genitalium
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/20191215005039/en/
Contact information
SpeeDx:
Europe, Australia, New Zealand:
Madeline O’Donoghue
+61 2 9209 4170
madelineo@speedx.com.au
Cepheid:
Darwa Peterson
darwa@cepheid.com
Tel. + 1.408.400.4324
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
Incyte Announces Positive CHMP Opinion for Opzelura ® (ruxolitinib) Cream for the Treatment of Adults with Moderate Atopic Dermatitis26.6.2026 14:30:00 EEST | Press release
Incyte (Nasdaq: INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Opzelura® (ruxolitinib) cream for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs) are inadequate or inappropriate. “AD is a chronic skin condition that can have a significant impact on daily life. The positive CHMP opinion for Opzelura marks meaningful progress toward bringing the first non-steroidal topical JAK treatment option to adults in Europe with moderate AD for whom standard topical therapies have failed,” said Lee Heeson, Executive Vice President and Head of Incyte International. “If approved by the European Commission, Opzelura could help address an important gap for patients who have limited treatment options when TCSs and TCIs are inadequate or inappropriate.” The positive CHMP o
Datroway ® Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with Metastatic Triple Negative Breast Cancer Who Are Not Candidates for Immunotherapy26.6.2026 14:00:00 EEST | Press release
Datroway® (datopotamab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the TROPION-Breast02phase 3 trial, which werepresented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology. The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU. In TROPION-Breast02, Datroway demonstrated a
DAYBU ® (trofinetide) Recommended for Approval in the European Union by CHMP26.6.2026 13:49:00 EEST | Press release
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion following a re-examination procedure, recommending the granting of a marketing authorization for DAYBU® (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. If granted marketing authorization by the European Commission, DAYBU® would be the first therapy approved for this indication in the European Union (EU). “The CHMP’s positive opinion for DAYBU® is an important milestone in our mission to bring this innovative therapy to the EU, where there are no therapies specifically approved for the neurobehavioral symptoms of this devastating condition," said Catherine Owen Adams, Acadia’s Chief Executive Officer. “Our commitment is to make a meaningful difference in the lives of patients, caregivers, and the wider Rett com
HTEC Showcases Lakebase Branching at Databricks’ Data & AI Summit26.6.2026 12:18:00 EEST | Press release
HTEC, the global technology and AI engineering firm headquartered in Silicon Valley, last week showcased how it used Lakebase data branching to enable faster development, safer operations, and new possibilities for data-driven organizations operating in highly regulated environments. The Solution was developed in collaboration with a leading risk and compliance technology provider who serves financial institutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260626875859/en/ HTEC, the global technology and AI engineering firm headquartered in Silicon Valley, last week showcased how it used Lakebase data branching to enable faster development, safer operations, and new possibilities for data-driven organizations operating in highly regulated environments. Solving Critical Development Bottlenecks in Regulated Environments At the core of the collaboration was a shared challenge: how to enable modern data workflows in an envi
Stallergenes Greer Named One of Switzerland’s Best Managed Companies for 202626.6.2026 11:28:00 EEST | Press release
Stallergenes Greer, a global leader in allergy care, has been recognised for its overall business performance, company culture, and sustained growth by receiving the prestigious 2026 Switzerland’s Best Managed Companies award. The 2026 Best Managed Companies programme award winners are among Switzerland’s best private companies. The awards are derived from Deloitte’s global Best Managed Companies awards programme, an internationally recognised programme that evaluates businesses based on their leadership in the areas of strategy, culture and commitment, capabilities, innovation, governance and financial performance. Applicants are evaluated by an independent jury of experts. The evaluation of the Switzerland awards is based on more than 30 years of observed practice from the global awards programme that has been rolled out in 50+ countries worldwide. This recognition reflects Stallergenes Greer's consistent ability to deliver on its strategic vision while maintaining the operational di
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