NASDAQ OMX

SpeeDx Pty. Ltd. establishes US-based operation

Dela

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

NASDAQ OMX
NASDAQ OMX



Följ NASDAQ OMX

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från NASDAQ OMX

Navigators to Acquire Belgian Specialty Insurer18.12.2017 07:30Pressmeddelande

STAMFORD, CT, December 18, 2017 - The Navigators Group, Inc. (NASDAQ:NAVG) today announced that it has entered into a share purchase agreement for the purchase of all of the shares of Assurances Continentales - Continentale Verzekeringen NV ("ASCO") and Bracht, Deckers & Mackelbert NV ("BDM").  ASCO and BDM are both based in Antwerp, Belgium. The proposed acquisition is part of Navigators' strategy of expanding its well-established specialty insurance expertise to more brokers and insureds across Europe. ASCO is a specialty insurance company offering marine and property and casualty insurance. BDM is an insurance underwriting agency that underwrites risk coverage in niche markets on behalf of ASCO and a number of major international insurers. Additionally, as part of the transaction, Navigators will acquire all the shares of Canal Re SA, a Luxembourg reinsurance company that is a wholly-owned subsidiary of ASCO.  The acquisition reinforces Navigators' presence in the European Un

Oxford Immunotec and QIAGEN N.V. Settle Patent Infringement Lawsuit15.12.2017 22:04Pressmeddelande

Agreement includes payment of $27.5 million to Oxford, royalty-free license to QIAGEN and dismissal of all pending litigation OXFORD, United Kingdom and MARLBOROUGH, Mass., Dec. 15, 2017 (GLOBE NEWSWIRE) -- Oxford Immunotec Ltd. (Nasdaq:OXFD) and QIAGEN N.V. (Nasdaq:QGEN) (Frankfurt Stock Exchange:QIA) announced today that they have reached a settlement in the lawsuit in the U.S. District Court for the District of Massachusetts in Boston (15-cv-13124-NMG) alleging patent infringement in relation to QIAGEN's QuantiFERON®-TB Gold and QuantiFERON®-TB Gold Plus products. Under terms of the agreement, all pending claims between Oxford and QIAGEN and the co-defendants have been resolved. As part of the settlement, Oxford has granted QIAGEN a royalty-free, non-exclusive license that extends to all current and future customers of QuantiFERON-TB Gold and QuantiFERON-TB Gold Plus in exchange for a one-time, lump-sum payment of $27.5 million.  The settlement includes general

Algeco Scotsman Announces Acquisition of Iron Horse Ranch15.12.2017 21:32Pressmeddelande

BALTIMORE, Dec. 15, 2017 (GLOBE NEWSWIRE) -- Algeco/Scotsman Holding S.à r.l. (together with its subsidiaries, the "Algeco Group") today announced the successful closing of the acquisition by the Algeco Group's subsidiary, Target Logistics Management, LLC ("Target Logistics"), of Iron Horse Ranch from funds managed by TDR Capital LLP ("TDR"). The acquisition solidifies Target Logistics' position as the single largest provider of turnkey workforce housing in the U.S., including a network of eight lodges and 2,119 beds in the Permian Basin. With the acquisition, Target Logistics' Permian Basin lodge network now includes Texas lodges in Pecos, Mentone, San Angelo and two in Odessa, along with two lodges in Carlsbad and Lovington, New Mexico. Additionally, Target Logistics adds Eagle Ford lodges in Cameron and Yorktown, Texas. Diarmuid Cummins, CEO Algeco Scotsman: "Today we announce the completion of the second of two strategic acquisitions which we flagged earlier

Repurchase of own shares in Momentum Group AB (publ)15.12.2017 15:25Pressmeddelande

In accordance with the authorisation issued by the Extraordinary General Meeting of Shareholders held on 28 November 2017, Momentum Group AB (publ) has repurchased 28,800 Class B shares at an average price of SEK 103.34 per share. After the repurchase, Momentum Group AB's current holding of treasury shares amounts to 28,800 Class B shares, corresponding to 0.1 percent of the total number of shares and 0.1 percent of the total number of votes. The total number of shares in Momentum Group AB, including those held by the Company, amounts to 28,265,416, of which 1,062,436 are Class A shares and 27,202,980 are Class B shares. The total number of votes in Momentum Group AB is 37,827,340. Stockholm, 15 December 2017 Momentum Group AB (publ) For further information, please contact: Mats Karlqvist, Head of Investor Relations - Tel: +46 70 660 31 32 This information was submitted for publication on 15 December 201

Återköp av egna aktier i Momentum Group AB (publ)15.12.2017 15:25Pressmeddelande

I enlighet med bemyndigandet från den extra bolagsstämman den 28 november 2017 har Momentum Group AB (publ) återköpt 28 800 aktier av serie B till en genomsnittskurs av 103,34 SEK per aktie. Momentum Group ABs aktuella innehav av egna aktier efter återköpet uppgår till 28 800 aktier av serie B, vilket motsvarar 0,1 procent av totalt antal aktier och 0,1 procent av totalt antal röster. Det totala antalet aktier i Momentum Group AB, inklusive de av bolaget ägda aktierna, uppgår till 28 265 416 st, av vilka 1 062 436 är aktier av serie A och 27 202 980 är aktier av serie B. Det totala antalet röster i Momentum Group AB är 37 827 340. Stockholm den 15 december 2017 Momentum Group AB (publ) För ytterligare information vänligen kontakta: Mats Karlqvist, Head of Investor Relations - telefon 070-660 31 32 Informationen lämnades för offentliggörande den 15 december 2017 kl. 15:15 CET.  

Elemica Named to Food Logistics Top 100 List15.12.2017 13:55Pressmeddelande

11th Consecutive Win for Delivering Value Across Clients' Supply Chains WAYNE, Pa., Dec. 15, 2017 (GLOBE NEWSWIRE) -- Elemica, the leading  Business Network for the process industries, announces the company has been named to Food Logistics magazine's FL100+ Award for the 11th year. The FL100+ list recognizes leading software and technology providers in the food and beverage industry.  Elemica was chosen for helping agricultural and food ingredient businesses conduct more efficient and error free commerce across their community of suppliers, customers and logistics providers - delivering value through lower operating expenses and working capital costs. "We are honored to be included for the past eleven years on the Food Logistics FL100+ list for helping companies improve efficiencies and generate value from their supply chains," said John Blyzinskyj, CEO of Elemica. "Automating business processes, enabling end-to-end visibility, and providing a platform for

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

Besök vårt pressrum