GlobeNewswire

SpeeDx Pty. Ltd. establishes US-based operation

Del

Subsidiary prepares for expected 2018 US product launch

SYDNEY, Australia, Dec. 04, 2017 (GLOBE NEWSWIRE) -- SpeeDx Pty. Ltd, a developer of advanced multiplex molecular diagnostic solutions, announced the incorporation of a US-based subsidiary company, SpeeDx Inc.   The parent company, headquartered in Australia, will use the US base to support current clinical trial activity for ResistancePlus(TM) MG (not currently for sale in the US), in preparation for an expected 2018 launch. The SpeeDx ResistancePlus(TM) MG test detects the sexually transmitted bacteria Mycoplasma genitalium along with mutations that confer resistance to azithromycin, the front-line antibiotic treatment of choice.

ResistancePlus(TM) MG will potentially be a first-to-market molecular diagnostic test in the US, providing both detection of the MG infection along with information about antibiotic resistance of the disease.  The test previously received regulatory clearances in Europe, Australia and New Zealand and is already experiencing strong sales in those locations. SpeeDx recently signed a partnership agreement with Thermo-Fisher to help bring the ResistancePlus(TM) MG test to the US and a distribution agreement with Cepheid in Europe for their PlexPCR(TM) and ResistancePlus(TM) tests.

"We have always had the goal of bringing ResistancePlus MG to the US market", said Colin Denver, CEO of SpeeDx, "local offices and staff will allow us to more easily navigate the FDA approval process and keep us on track for our product launch next year."

A rapid rise in resistant strains of M. genitalium across the globe has led to international guidelines for the management of M. genitalium infections that recommend testing for macrolide resistance to better inform treatment options.1 With M. genitalium prevalence rapidly increasing in the US, and in some instances exceeding that of Chlamydia,2 it is expected that US guidelines will also be updated to address antimicrobial resistance in this significant sexually transmitted disease (STD).

 "Our aim is to empower clinicians and physicians to make the best treatment decisions about the diseases they are faced with," said Colin Denver.  "Ultimately, we want to support individualised patient management and better antimicrobial stewardship, which will help patients quickly receive the best treatment for their disease and for physicians to better address antibiotic resistance challenges."

About MG
Mycoplasma genitalium 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.3 Like Gonorrhea, MG 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.4

Macrolide antibiotics, specifically azithromycin, are the first-line treatment for M. genitalium infections, but resistance to these antibiotics has increased up to 50 percent in several countries.4  New European Guidelines for the treatment of M. genitalium infections were released last year recommending the molecular detection of M. genitaliumwith an assay capable of detecting macrolide resistance-associated mutations.1 Timely detection of antibiotic resistant infections enables better treatment of the disease, lessens the potential for spreading among vulnerable populations and combats the rising level of antibiotic resistance.

Currently, there is not a commercially available, FDA-cleared molecular diagnostic test for the detection of MG.

About SpeeDx
Founded in 2009, SpeeDx is an Australian-based private company with offices in London 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. Currently, SpeeDx markets the only CE-marked and TGA approved commercial molecular test for the STI M. genitalium (ResistancePlus(TM) MG) that combines detection of the disease with detection of markers for antibiotic resistance. For more information about SpeeDx please see: http://www.plexpcr.com

1 Jensen, JS. et al 2016. 2016 European Guidelines on Mycoplasma genitalium Infections.
2 Getman D et al. Mycoplasma genitalium prevalence, coinfection, and macrolide antibiotic resistance frequency in a
multicenter clinical study cohort in the United States. J ClinMicrobiol 2016; 54:2278-2283.
3 Centers for Disease Control and Prevention, 2015 Sexually Transmitted Diseases Treatment Guidelines.
4 Unemo, M & Jensen, JS. Antimicrobial-resistant sexually transmitted infections: gonorrhoea and Mycoplasma genitalium. 2016. Nat. Rev. Urol. 268. Published online 10 Jan 2017. doi:10.1038/nrurol

Contacts for SpeeDx: 
Madeline O'Donoghue 
madelineo@speedx.com.au 
+61 2 8212 8512 (ext 008)




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 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

Compuware Announces Day One Support for IBM CICS Transaction Server for z/OS V5.514.12.2018 18:02Pressemelding

DETROIT, Dec. 14, 2018 (GLOBE NEWSWIRE) -- Compuware Corporation, the world’s leading mainframe-dedicated software company, is pleased to announce Day One support for IBM CICS Transaction Server (TS) for z/OS V5.5. Compuware worked in collaboration with IBM to ensure that its solutions—including Abend-AID, File-AID, Strobe, Topaz and Xpediter—work seamlessly for z/OS customers installing or upgrading to this newest version of CICS TS. New capabilities within CICS TS V5.5 include support for JavaScript Node.js applications; an enhanced CICS Explorer; as well as advancements in systems management and enhanced security. “Compuware has an extensive history of ensuring our products work seamlessly with IBM releases and the release of CICS Transaction Server V5.5 is no exception,” said Sam Knutson, Vice President of Product Management for Compuware. “Our solutions excel at helping enterprises include the mainframe in their cross-platform Agile DevOps practices and processes so they can succe

SoftServe Achieves Machine Learning Specialization in Google Cloud Partner Program14.12.2018 13:00Pressemelding

Google Cloud recognizes SoftServe’s technical proficiency and proven success AUSTIN, Texas, Dec. 14, 2018 (GLOBE NEWSWIRE) -- SoftServe, a leading digital authority and consulting company, announces it achieved the Machine Learning Partner Specialization in the Google Cloud Premier Partner Program. The Partner Specialization affirms SoftServe’s expertise and success building customer solutions in the machine learning field using Google Cloud Platform (GCP) technology. The Google Cloud Partner Specialization Program is designed to provide Google Cloud customers with qualified partners that demonstrate technical proficiency in the specialized solution and service areas. Specifically, the Machine Learning Specialization demonstrates SoftServe’s expertise in data exploration, preprocessing, model training, model evaluation, model deployment, online prediction, and Google Cloud’s pre-trained machine learning APIs. “We teach machines to learn, read, see and understand business data, and make

Minerals Technologies Announces Price Increases for Specialty Minerals Products in Europe14.12.2018 00:01Pressemelding

NEW YORK, Dec. 13, 2018 (GLOBE NEWSWIRE) -- Specialty Minerals Inc. (“SMI”), a subsidiary of Minerals Technologies Inc., announced today that effective February 1, 2019, it will increase prices by up to 10% for all coated ultrafine precipitated calcium carbonate (PCC) from SMI’s Lifford Specialty PCC facility in Birmingham, UK, subject to individual customer contracts and market provisions. The price increases reflect increased market demand for higher performance materials, as well as significant inflation in input, raw material and logistics costs. About Minerals Technologies Inc. New York-based Minerals Technologies Inc. (MTI) is a resource- and technology-based growth company that develops, produces and markets worldwide a broad range of specialty mineral, mineral-based and synthetic mineral products and related systems and services. MTI serves the paper, foundry, steel, construction, environmental, energy, polymer and consumer products industries. The Company reported sales of $1.

Synthesio to Bring Proven Ipsos Data Science to Artificial Intelligence13.12.2018 17:03Pressemelding

Synthesio's Next-Generation Social Media Intelligence to Raise Unseen Insights to the Surface, Faster NEW YORK, Dec. 13, 2018 (GLOBE NEWSWIRE) -- Synthesio, an Ipsos company, and also the leading Social Media Intelligence Suite, today announced the plans for its next-generation Artificial Intelligence (AI) engine. The project will combine Synthesio’s AI technology with Ipsos’ data science. The combination will power upcoming Synthesio capabilities to help users find insights faster, remove guesswork, and make informed business decisions across a variety of use cases. “Our goal has always been to provide customers with meaningful data, visualized so that they can make strategic business decisions,” explained Loic Moisand, CEO & Founder of Synthesio. “The less guesswork that a company has to make, and the less time that it takes users to find meaningful insights, the more time for data-backed business decisions. We are really pleased that we can leverage the data science capabilities dev

XBiotech Announces Publication of Post-Hoc Analysis for Phase III Colorectal Cancer Study13.12.2018 14:00Pressemelding

Biomarkers Predict Significantly Higher Rates of Treatment Response to Bermekimab in Advanced Cancer Patients AUSTIN, Texas, Dec. 13, 2018 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) announced today the publication of findings on key biomarker analysis of colorectal cancer patients treated with bermekimab in its European Phase III study. The manuscript, entitled, “Interleukin-1 Receptor Antagonist (IL-1ra) Levels Predict Favorable Outcome after Bermekimab, a First-in-Class True Human Interleukin-1α Antibody, in a Phase III Randomized Study of Advanced Colorectal Cancer”, has been published online in the journal OncoImmunology. The findings report that patients with relatively low levels of IL-1ra or IL-6 were more likely to respond to bermekimab therapy and achieve the study’s primary endpoint. The study’s primary endpoint measured a combination of physical symptoms—pain, fatigue, anorexia and muscle wasting—which tend to worsen with advanced cancer, to assess whether these sympto

FROM CUTE TO CONFIDENT: MARY KAY INC. TALKS PINK AT THE MUSEUM AT FIT13.12.2018 14:00Pressemelding

Mary Kay Inc. and The Museum at The Fashion Institute of Technology Partner for a Pink-Centric Panel Discussion in Conjunction with Special Exhibition ‘Pink: The History of a Punk, Pretty, Powerful Color’ NEW YORK, N.Y., Dec. 13, 2018 (GLOBE NEWSWIRE) -- From pink makeup compacts to the iconic pink Cadillac, global beauty brand Mary Kay has been synonymous with the color pink for more than five decades. On December 13, 2018, Mary Kay will partner with The Museum at FIT (MFIT) to host a scholarly panel discussion, ‘Powerful Pink: From Cute to Confident,’ at the Katie Murphy Amphitheatre on the New York City FIT campus. Panelists include Luis Casco, Mary Kay Global Beauty Ambassador and celebrity makeup artist; Kate Greene, Vice President of Communications and Creative Direction at Givaudan and Karen Young, FIT adjunct professor and founder of The Young Group. The panel discussion will be moderated by Sheryl Adkins-Green, Chief Marketing Officer for Mary Kay Inc. The scholarly panel disc