GlobeNewswire

SpeeDx Begins Multisite U.S. Clinical Trials of ResistancePlus® MG Test

Del

Test supports international guidelines for treating antibiotic resistant STI

SYDNEY, Australia, Sept. 25, 2018 (GLOBE NEWSWIRE) -- SpeeDx Pty. Ltd. today announced the start of patient testing in their multisite U.S.-based clinical trials for ResistancePlus® MG (not available for sale in the U.S.). The molecular diagnostic test detects the sexually transmitted infection (STI) Mycoplasma genitalium, also known as Mgen or MG, along with genetic markers linked to antibiotic resistance. In recent years, Mgen prevalence has increased globally and developed high rates of resistance to the common antibiotic treatment, azithromycin.

"This test is an exciting new development that will increase the precision of patient care for patients impacted by Mycoplasma genitalium - a common sexually transmitted infection with limited treatment options,” notes Dr Maria Trent, Professor of Pediatrics and Public Health at Johns Hopkins Medicine.

The SpeeDx ResistancePlus MG test is in use in laboratories across Europe, U.K., Australia, and New Zealand. However, there is not currently a U.S. Food and Drug Administration-cleared commercially available test for Mgen. SpeeDx is expecting clearance of ResistancePlus MG in 2019 with U.S. clinical trials now beginning at the University of Alabama at Birmingham, Johns Hopkins University, and TriCore Reference Laboratories.

“This is an important new test that has now influenced Mgen treatment guidelines in Europe1, the UK2, and Australia3,” said Colin Denver, CEO of SpeeDx. “We are delighted with the progress of our U.S. clinical trial sites and we are excited to be able to offer the test in the U.S. market in the near future.”

In a recent peer-reviewed study published in Clinical Infectious Diseases 4, the authors recorded an overall cure rate of >92% when using Resistance Guided Therapy with the ResistancePlus MG test - a significant increase compared with previous cure rates below 60%. Resistance to azithromycin, a commonly recommended treatment for M. genitalium infection, has risen to over 50% in many countries around the world.5,6 Data from this study has already influenced recent STI management guideline updates in Australia3 and the United Kingdom2, with recommendations to assess the resistance status of M. genitalium infections in order to guide appropriate treatment. Using diagnostics to define appropriate treatment decisions results in a more effective use of antibiotics, curtails the use of inappropriate prescribing and helps preserve the use of key medicines needed to combat the global rise of antimicrobial resistance.

About M. genitalium
M. genitalium is a sexually transmitted infection (STI) that can cause symptoms such as urethritis, cervicitis, endometritis and pelvic inflammatory disease. In recent studies, it has been found to have a higher prevalence than gonorrhea.7 Like Neisseria gonorrhoeae, M. genitalium is also evolving into a so-called STI superbug that is becoming resistant to many antibiotic treatments leading to exceedingly difficult to treat infections and threatening global public health.8 Macrolide antibiotics, specifically azithromycin, are the first-line treatment for the rapidly growing problem of M. genitalium STIs, but resistance to these antibiotics has increased up to 50% in several countries.4-6 Due to this growing antibiotic resistance problem, several global STI Management Guidelines on M. genitalium Infections recommend complementing the use of molecular testing to detect M. genitalium with an assay capable of detecting macrolide resistance-associated mutations.1-3

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

  1. Jensen JS, Cusini M, Gomberg M, Moi H. 2016. 2016 European guideline on Mycoplasma genitalium infections. Journal of European Academy Dermatology & Venereology. PMID: 27505296.
  2. https://www.bashhguidelines.org/media/1146/ngu-update-05_2017-final.pdf
  3. http://www.sti.guidelines.org.au/sexually-transmissible-infections/mycoplasma-genitalium
  4. 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 
  5. Getman D, Jiang A, O'Donnell M, Cohen S. Mycoplasma genitalium prevalence, coinfection, and macrolide antibiotic resistance frequency in a multicenter clinical study cohort in the United States. Journal of Clinical Microbiology 2016; 54:2278-2283. 
  6. Murray GL, Bradshaw CS, Bissessor M, et al. Increasing Macrolide and Fluoroquinolone Resistance in Mycoplasma genitalium. Emerging Infectious Diseases. 2017; 23(5):809-812.
  7. 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.
  8. Unemo M & Jensen JS. Antimicrobial-resistant sexually transmitted infections: gonorrhoea and Mycoplasma genitalium. Nature Reviews Urology. 2017; 14:139-152.

Contacts:

Europe, Australia, New Zealand                                                   
Madeline O’Donoghue                                  
madelineo@speedx.com.au                          
+61 2 9209 4170

United States
Rick Roose
roi.roose@gmail.com
+1.415.202.4445

Om GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

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

Family of Constant-Current Dimmable Buck LED Drivers18.12.2018 11:00Pressemelding

1.5A, 3A Buck LED Drivers Target ISO26262 automotive and industrial applications MILPITAS, Calif., Dec. 18, 2018 (GLOBE NEWSWIRE) -- AMS, the Analog Mixed-Signal division of ISSI, has introduced a family of switching buck LED Drivers for automotive and industrial applications. This family of highly integrated switching constant current buck LED Drivers are targeted for 12V/24V battery connected, space-constrained, electromagnetic (EMC) sensitive applications such as Headlight, Front and Rear Fog lights, Day time Running lights to name a few. The device family supports a wide DC voltage input range of 4.5V to 38V and outputs a 5% regulated current of 1.5A or 3A; depending on the particular device, see table. The integrated power MOSFET is configured to switch in the constant on-time mode delivering true average current. Switching at a frequency of up to 2MHz which is adjustable with an external resistor, these buck LED Drivers can use smaller output inductor and capacitor values thereby

John Charman Appointed Chief Executive Officer of Sompo Holdings Overseas Insurance Business and Nigel Frudd Appointed as Chief Executive Officer of Sompo International18.12.2018 10:13Pressemelding

Mr. Charman and Mr. Frudd to Join Sompo Holdings New Global Executive Committee PEMBROKE, Bermuda, Dec. 18, 2018 (GLOBE NEWSWIRE) -- Sompo International Holdings Ltd. (Sompo International), a Bermuda-based specialty provider of property and casualty insurance and reinsurance, announced today that effective April 1, 2019, Mr. John Charman, currently Chairman of the Board of Directors and Chief Executive Officer of Sompo International, will be promoted to Chief Executive Officer of Overseas Insurance Business in Sompo Holdings, Inc. (Sompo Holdings). This segment of Sompo Holdings’ business currently represents more than 27% of Sompo Holdings Group’s adjusted profit, employing around 9,000 people in 30 countries and regions and is projected to have more than $10 billion in gross premiums by 2020. In such capacity, Mr. Charman will join the new Global Executive Committee of Sompo Holdings (Global ExCo) which will be established in April 2019 to provide expertise and input on group-wide st

LeddarTech Selects BlackBerry’s QNX Operating System for its Auto and Mobility LiDAR Platform18.12.2018 06:05Pressemelding

The QNX OS for Safety runs the software at the core of LeddarTech’s innovative automotive LiDAR development platform that enables the design of differentiated LiDAR solutions tailored to specific autonomous driving applications. QUEBEC CITY, Dec. 18, 2018 (GLOBE NEWSWIRE) -- LeddarTech , an industry leader providing the most versatile, scalable Auto and Mobility LiDAR Platform, today announced it has selected the QNX OS for Safety as the operating system for its LeddarSP Digital Signal Processing library. The LeddarSP software works in tandem with LeddarCore systems-on-chip to form the LeddarEngine, which is embedded at the heart of a variety of LiDAR sensor designs that enable ADAS and autonomous driving applications. “We believe that there is no safety without security,” said Grant Courville, VP of QNX Product Management and Strategy at BlackBerry. “We are thrilled to provide LeddarTech, an industry leader in LiDAR technology, with the reliable foundation necessary for building compe

Align Technology Reaches 6 Millionth Invisalign® Patient Milestone With Tween Patient From China18.12.2018 02:30Pressemelding

12-year old Yuzhe Wang from Beijing, China is in treatment with Invisalign trained doctor Jiawei Wo using Invisalign Comprehensive with Mandibular Advancement Accelerating adoption of Invisalign clear aligner treatment globally reflects Align’s continued investment in product innovation and commitment to international expansion BEIJING and SAN JOSE, Calif., Dec. 17, 2018 (GLOBE NEWSWIRE) -- Align Technology, Inc. (NASDAQ: ALGN) today announced that over 6 million patients have begun treatment with Invisalign - the most advanced clear aligner system in the world, including 1.4 million teenage patients*. This is a significant milestone for the company and the over 150,000 Invisalign-trained doctors worldwide, reflecting accelerating adoption of Invisalign treatment by adults and teens alike. The 6 millionth Invisalign patient, Yuzhe Wang, is a 12-year-old student of the International School of Beijing, who began treatment in October 2018 using Invisalign Comprehensive with Mandibular Adv

Euronet USA’s Advanced Technology Solution Selected by Banco de Moçambique for Their National Payment Network18.12.2018 00:15Pressemelding

LEAWOOD, Kan., Dec. 17, 2018 (GLOBE NEWSWIRE) -- On Monday, December 10, 2018, Euronet USA, Inc. signed an agreement with Banco de Moçambique to provide a modernized national payment network solution to Mozambique. Under the agreement, Euronet will provide state-of-the-art software for the financial system in Mozambique. Euronet’s superior technology combined with over 40 years of experience in the payments landscape makes them well suited to deliver a robust solution to meet the country’s existing and future requirements. This arrangement recognizes Euronet’s leadership position in the region as this solution will be used to drive all payment processing in the country. “We are extremely honored to grow our strong relationship with the country of Mozambique, by providing advanced and scalable products and services that we deploy successfully around the world,” said Cindy Ashcraft, Vice President of Euronet Worldwide and Managing Director of Euronet Software Solutions, headquartered in

ProQR Announces Publication in Nature Medicine of QR-110 Data for Leber’s Congenital Amaurosis 1017.12.2018 17:52Pressemelding

LEIDEN, Netherlands and CAMBRIDGE, Mass., Dec. 17, 2018 (GLOBE NEWSWIRE) -- ProQR Therapeutics N.V. (Nasdaq:PRQR), a company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe genetic rare diseases, today announced the publication of a peer-reviewed manuscript describing the previously announced interim results of a clinical trial of QR-110 for the treatment of Leber’s congenital amaurosis 10 (LCA10) in the journal Nature Medicine. “It was enormously gratifying to see robust improvements in visual acuity and significant augmentations in the patient’s ability to detect lights, and impressive to observe these effects within the first three months following a single injection,” said Professor Artur V. Cideciyan, Ph.D., who was one of the co-investigators at the Scheie Eye Institute of the University of Pennsylvania. “LCA10 is a severe form of childhood blindness and this is a major step forward in the treatment of these previously