NASDAQ OMX

Clinical data demonstrates significantly increased cure rates using Resistance Guided Therapy for treating the STI Superbug M. genitalium

Dela

SpeeDx ResistancePlus® MG test supports new STI management guidelines

SYDNEY, Australia, June 21, 2018 (GLOBE NEWSWIRE) -- SpeeDx Pty. Ltd. today announced clinical data contained in a new study published in the June 2018 issue of Clinical Infectious Diseases 1 [link ] supports the use of Resistance Guided Therapy for more effective treatment of Mycoplasma genitalium infections. Using the SpeeDx ResistancePlus® MG test, the authors recorded an overall cure rate of >92%, a significant increase compared with previous cure rates of 67% prior to using Resistance Guided Therapy.ResistancePlus MG test simultaneously detects the sexually transmitted infection (STI) M. genitalium and the genetic markers linked to antimicrobial resistance (AMR).

The test is CE marked and in use across Europe, and available in laboratories across Australia and New Zealand. Clinical trials are underway in the U.S. in preparation for de novo clearance for the test with the U.S. Food and Drug Administration. 

"This is a seminal publication demonstrating a remarkable improvement in treating what has essentially become an STI superbug," said Colin Denver, SpeeDx CEO. "Using diagnostics to define appropriate treatment decisions is key when dealing with the global health threat of antimicrobial resistance."

Senior study author Associate Professor Catriona Bradshaw has worked on M. genitalium for 15 years. "I've seen resistance to azithromycin, the frontline recommended treatment for M. genitalium infection, rise to over 50% in Melbourne over the last decade," she said. "Unfortunately, it's now a situation mirrored in many countries around the world."1

Within the context of high level resistance and ongoing use of azithromycin - which helps to further increase macrolide resistance - the team developed a three-tier treatment pathway. The first step was switching from azithromycin to doxycycline for initial treatment, and then using the ResistancePlus MG test to detect macrolide resistance biomarkers. If macrolide resistance was detected, patients were treated with a quinolone antibiotic (sitafloxacin) to avoid unnecessary and ineffective use of azithromycin. If macrolide resistance was not detected, the patient was given a higher than standard dose of azithromycin over 4 days to reduce the development of de novo resistance.

Importantly, using doxycycline for initial STI treatment reduces overall use of azithromycin and reduces bacterial load, which the authors hypothesise improves the effectiveness of subsequent macrolide or quinolone treatment. Ongoing work will evaluate the use of moxifloxacin rather than sitafloxacin following doxycycline, as this agent is more widely available.

Data from this study has already influenced recent STI management guideline updates in Australia2 and the United Kingdom3, with recommendations to use doxycycline upfront and to assess the resistance status of M. genitalium infections in order to guide appropriate treatment. Using diagnostics to define appropriate treatment decisions is in line with recent recommendations on global management of AMR.8 Resistance Guided Therapy 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 gonorrhoea.4 Like gonorrhoea, 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. 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.1,5,6 Due to this growing antibiotic resistance problem, several global STI Management Guidelines on M. genitaliumInfections recommend complementing the use of molecular testing to detect M. genitalium with an assay capable of detecting macrolide resistance-associated mutations.2,3,7

Currently, there is not a Food & Drug Administration (FDA) cleared molecular diagnostic test for the detection of M. genitalium in the US. The SpeeDx ResistancePlus® MG assay is CE marked for sale in Europe and TGA approved for sale in Australia. The test provides valuable detection and antibiotic resistance information to clinicians in a rapid time frame. Timely detection of antibiotic resistant infections enables better treatment of the disease for patients, lessens the potential for spreading among vulnerable populations and combats antibiotic resistance.

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. 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
  2. http://www.sti.guidelines.org.au/sexually-transmissible-infections/mycoplasma-genitalium
  3. https://www.bashhguidelines.org/media/1146/ngu-update-05_2017-final.pdf
  4. 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.
  5. 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.
  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. doi:10.3201/eid2305.161745.
  7. Jensen JS, Cusini M, Gomberg M, Moi H. 2016. 2016 European guideline on Mycoplasma genitalium infections. J Eur Acad Dermatol Venereol. PMID: 27505296.
  8. O'Neill J. The Review on Antimicrobial Resistance. May 2016:35.

Contacts:

First Author:
Tim Read
NHMRC Research Fellow, Central Clinical School, Monash University
Sexual Health Physician, Melbourne Sexual Health Centre
tread@mshc.org.au
+61 3 9341 6255

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




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: SpeeDx Pty Ltd via Globenewswire

Om

NASDAQ OMX
NASDAQ OMX



Följ NASDAQ OMX

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från NASDAQ OMX

Immunicum AB (publ) Announces Appointment of Pawel Kalinski and Inge Marie Svane to Scientific Advisory Board17.9.2018 08:00Pressmeddelande

Press Release 17 September 2018 Immunicum AB (publ) Announces Appointment of Pawel Kalinski and Inge Marie Svane to Scientific Advisory Board Immunicum AB (publ; IMMU.ST) announced today the appointment of leading oncology experts to its Scientific Advisory Board with the addition of Pawel Kalinski, MD, PhD, Vice Chair for Translational Research within the Department of Medicine at Roswell Park Comprehensive Cancer Center, and Inge Marie Svane, MD, PhD, Professor, Head of the Clinical Cancer Research programme, Faculty of Health Sciences, University of Copenhagen, Director, Centre for Cancer Immunotherapy (CCIT), and consultant in Oncology, Herlev University Hospital. Both Scientific Advisory Board members will serve as a strategic resource to Immunicum as the company continues to advance the clinical development of its lead product, ilixadencel. "We are honored to have such highly specialized experts in the field of immuno-oncology and cell therapy join our Scientific Advisory Board a

Immunicum AB (publ) meddelar att Pawel Kalinski och Inge Marie Svane har valts in i det vetenskapliga rådet17.9.2018 08:00Pressmeddelande

Pressmeddelande 17 september 2018 Immunicum AB (publ) meddelar att Pawel Kalinski och Inge Marie Svane har valts in i det vetenskapliga rådet Immunicum AB (publ; IMMU.ST) meddelade i dag att två ledande immun-onkologiska experter har valts in i bolagets vetenskapliga råd för att fungera som strategiska resurser för Immunicum under bolagets fortsatta kliniska utveckling av sin ledande produkt, ilixadencel. Pawel Kalinski, MD, PhD, vice ordförande för translationell forskning vid den medicinska institutionen vid Roswell Park Comprehensive Cancer Center, och Inge Marie Svane, MD, PhD, professor, chef för det kliniska cancerforskningsprogrammet på medicinska fakulteten vid Köpenhamns universitet, chef för Center för cancerimmunterapi (CCIT) samt överläkare inom onkologi, Herlevs universitetssjukhus har valts in i rådet. - Vi är hedrade att ha experter med specialistkompetens inom området immunonkologi och cellterapi i vårt vetenskapliga råd, vilka kan erbjuda ytterligare vägledning när det

Hoylu AB: HOYLU HIRES NEW CTO, SATOSHI NAKAJIMA AND ANNOUNCES EXPANSION INTO JAPAN14.9.2018 08:30Pressmeddelande

Malmo, Sweden, September 14, 2018 - Hoylu, a leading enterprise collaboration company, announced today Satoshi Nakajima will join Hoylu in the newly created position, as Chief Technology Officer and President of Hoylu Japan. Nakajima will guide the strategic technology direction and innovation of Hoylu while also leading the new Hoylu office in Tokyo, Japan. "Satoshi is a visionary and world-class technologist who has substantial experience in delivering world class innovations. He is joining the Company as we are extending our reach and expanding into Japan," said Stein Revelsby, CEO. "Satoshi's extensive experience in strategy and delivering technology that support a great user experience will make an immediate impact on the company." Nakajima will serve as President of Hoylu Japan and will report to Stein Revelsby. His leadership will strengthen customer relations and help develop new business among emerging and established Japanese companies while strengthening the global position

Hoylu AB: HOYLU ANSTÄLLER SATOSHI NAKAJIMA SOM NY CTO OCH EXPANDERAR TILL JAPAN14.9.2018 08:30Pressmeddelande

Malmö, Sverige, 14 september 2018 - Hoylu, ett ledande företag inom samarbetsmjukvara för företagsmarknaden annonserar idag att Satoshi Nakajima tar anställning som CTO (Chief Technology Officer) och President för Hoylu Japan. Nakajima kommer styra den strategiska inriktningen för företagets produkter och leda innovationsarbetet. Han kommer också leda Hoylus nyöppnade kontor i Tokyo, Japan. Satoshi är en visionär teknologiexpert som har stor erfarenhet av att skapa innovativa lösningar. Han kommer till Hoylu samtidigt som vi utökar marknaden till att även täcka in Japan säger Stein Revelsby, VD. "Satoshis långa och gedigna erfarenhet i strategiska frågor och tekniska lösningar med fokus på användarupplevelse kommer få stor betydelse för oss." Nakajima kommer även att bli President för Hoylu Japan och kommer rapportera till Stein Revelsby. Hans ledarskap kommer stärka existerande kundrelationer och utveckla nya affärer på den japanska marknaden och samtidigt bidra till att flytta fram p

LeoVegas AB: LeoVentures invests in esports betting - Pixel.bet13.9.2018 08:45Pressmeddelande

The LeoVegas Group, through its wholly owned investment company LeoVentures Ltd, has acquired 51% of the shares in Pixel Holding Group Ltd, which runs the esports betting operator Pixel.bet. The investment amounts to EUR 1.5 million for 51 percent of the company and is made through a new issue. Pixel.bet's vision is to create the greatest gaming experience in betting on esports www.pixel.bet "Esports is an international and fast-growing area that engages millions of viewers and players every month. With this investment in Pixel.bet we as a Group will gain unique insight into a new and fast-growing segment," comments Gustaf Hagman, LeoVegas' Group CEO and co-founder of LeoVegas Mobile Gaming Group. "In Pixel.bet we have found a passionate team of entrepreneurs who come from the esports community. With its strong technology and mobile-first gaming experience, Pixel.bet is a perfect match for the LeoVegas Mobile Gaming Group. Together we will drive development for the absolute premier exp

LeoVegas AB: LeoVentures investerar i esport betting - Pixel.bet13.9.2018 08:45Pressmeddelande

LeoVegas-koncernen har, genom sitt helägda investmentbolag LeoVentures Ltd förvärvat Pixel Holding Group Ltd, som driver esport betting operatören pixel.bet. Investeringen uppgår till 1,5 miljoner euro för 51 procent av bolaget och görs genom en nyemission. Pixel.bets vision är att skapa den främsta spelupplevelsen inom betting på esport www.pixel.bet "Esport är ett internationellt och snabbt växande område som engagerar miljontals tittare och utövare varje månad. Med investeringen i Pixel.bet får vi som koncern en unik inblick i ett nytt och snabbt växande segment.", säger Gustaf Hagman, Group CEO och co-founder av LeoVegas Mobile Gaming Group. "I Pixel.bet fann vi ett passionerat entreprenörsteam som verkligen kommer inifrån esport communityn. Med en riktigt bra teknik och spelupplevelse utvecklad mobile-first är det en perfekt match med LeoVegas Mobile Gaming Group. Tillsammans ska vi driva utveckling för den absolut främsta upplevelsen inom esport betting.", säger Robin Ramm-Ericso

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum