SpeeDx Pty. Ltd. establishes US-based operation
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."
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.
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:
+61 2 8212 8512 (ext 008)
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 GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
New Elemica Trace Solution Delivers Shipment Risk Analysis for Digital Transformation19.3.2018 13:09 | Pressemelding
Real-Time Information Matched with GPS Locations Provides Accurate Delivery Information WAYNE, Pa., March 19, 2018 (GLOBE NEWSWIRE) -- Elemica, the leading Digital Supply Network for process manufacturing industries, introduces Elemica Trace, a solution that provides real-time shipment and risk visibility to customer service, transport planners, and supply chain managers, allowing them to monitor and proactively manage the movement of products to customers and inbound to manufacturing centers. "Shipment disruptions occur and teams can spend hours manually tracking down what is happening. What's worse, sometimes your customer complaint is the first indication you have of a late shipment," said Rich Katz, CTO of Elemica. "Trace eliminates the time and stress of tracking shipments and enables your teams to increase the positive interactions with your customers." Elemica Trace uses shipment data, carrier signals, a geo-location interface, and predictive algorithms to identify shipments in
Resverlogix Exceeds Full Enrollment for the Pivotal Phase 3 BETonMACE Clinical Trial19.3.2018 12:00 | Pressemelding
The BETonMACE trial has now surpassed 2,400 enrolled patients and topline data is expected around the end of 2018 CALGARY, Alberta, March 19, 2018 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) announced today that it has successfully surpassed the planned enrollment target of over 2,400 patients in the ongoing Phase 3 BETonMACE trial. The trial's first patient was enrolled on November 11th, 2015. The goal of the trial is to confirm the effect of Resverlogix' lead drug, apabetalone, in Cardiovascular Disease (CVD) patients with type 2 Diabetes Mellitus (DM) and low high-density lipoproteins (HDL). The primary endpoint of the BETonMACE trial is designed to establish a relative risk reduction (RRR) of Major Adverse Cardiac Events (MACE), narrowly defined as a single composite endpoint of cardiovascular death, non-fatal myocardial infarction (MI) and stroke. Secondary pre-specified endpoints in the trial will also examine renal function and MACE in patien
SolarWinds Places Highest on the Ability to Execute Axis in 2018 Gartner Magic Quadrant for Network Performance Monitoring and Diagnostics19.3.2018 11:30 | Pressemelding
AUSTIN, Texas, March 19, 2018 (GLOBE NEWSWIRE) -- SolarWinds, a leading provider of powerful and affordable IT management software, placed highest on the ability to execute axis in the 2018 Gartner Magic Quadrant for Network Performance Monitoring and Diagnostics1. This Gartner report evaluated 22 suppliers of Network Performance Monitoring and Diagnostics products. The firm's evaluation criteria for ability to execute included the following: product or service, overall viability, sales execution and pricing, market responsiveness and record, marketing execution, customer experience, and operations. Of all the vendors evaluated in the report, SolarWinds placed highest on the ability to execute axis. "For three years in a row, Gartner has positioned us as highest on the ability to execute axis in the Magic Quadrant for Network Performance Monitoring and Diagnostics. In our view, this result confirms our commitment to helping our customers manage their network operations with a powerful
Record High Number of Toll Transactions Cleared in Ireland in 201719.3.2018 10:51 | Pressemelding
ISSY LES MOULINEAUX, France, March 19, 2018 (GLOBE NEWSWIRE) -- The number of transactions processed through emovis's toll interoperability cloud-based hub in Ireland has reached a record high with over 50 million transactions cleared in 2017. Thanks to its toll interoperability solution, emovis is contributing to the improved mobility of millions of Irish drivers, by allowing them to travel seamlessly with just one toll tag across the whole country. As of January 2018, over 650,000 toll transponders are in use. With this new success, emovis demonstrates its leadership in designing and operating innovative mobility solutions that offer the best levels of service for road users in Ireland and throughout the world. About eToll.ie emovis was awarded the contract for managing Ireland's toll interoperability hub by the National Roads Authority (now Transport Infrastructure Ireland) in June 2013 following a competitive tender. As part of this contract, emovis designed, developed and is curre
Phenom People Set to Attend UNLEASH London19.3.2018 09:00 | Pressemelding
Candidate Experience Software Pioneer Attends UK Conference HORSHAM, Pa., March 19, 2018 (GLOBE NEWSWIRE) -- Phenom People, the leader in Talent Relationship Marketing (TRM), announced today that it will attend UNLEASH Conference & Expo on March 20-21 at the ExCel London. "We are no stranger to UNLEASH's strong turnout of highly passionate and forward-thinking individuals who are ready for the next big thing in technology. The inspiration and exchange of new ideas from the world's greatest thought leaders UNLEASH draws in every year, is what we look forward to the most," said Mahe Bayireddi CEO at Phenom People. "Our presence at this year's UNLEASH is vitally important as we continue to emerge as a global TRM leader with a growing list of European clients." UNLEASH, formerly HR Tech World, is held around the globe and was created to enhance the Future of Work by marrying technology with efficient business practices. UNLEASH London's speaker line-up consists of many big-league names inc
Abeona Therapeutics Reports Fourth Quarter 2017 Financial Results and Business Highlights16.3.2018 22:32 | Pressemelding
Investor Conference Call on Tuesday, March 27th at 10:00 am ET NEW YORK and CLEVELAND, March 16, 2018 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, today announced financial results for the fourth quarter. The Company will host a call to update investors on recent clinical developments and year-end financial results on Tuesday, March 27th at 10:00 am (Eastern). Interested parties are invited to participate in the call by dialing 877-407-9210 (toll free domestic) or 201-689-8049 (International). "The past year was marked by several defining events in the company's history, having advanced our two lead clinical programs, EB-101 in Epidermolysis Bullosa and ABO-102 in MPS IIIA, and initiated our third clinical program, ABO-101 in MPS IIIB. The strong safety and biopotency data observed in our three active clinical trials and the s
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom