GlobeNewswire

SpeeDx receives FDA clearance for Mycoplasma genitalium product

Del

SYDNEY, Australia, April 19, 2018 (GLOBE NEWSWIRE) -- SpeeDx's  Resistance Plus ® MG Positive Control kit has now been listed with the US Food and Drug Administration (FDA) for sale in the United States through the company's recently incorporated US entity, SpeeDx Inc. The announcement coincides with the FDA registration of the Australian parent company - SpeeDx Pty Ltd - as a Medical Device Manufacturing Establishment, and clinical trials remain on-track for the  Resistance Plus MG assay.*

The  Resistance Plus MG Positive Control kit contains synthetic DNA to simulate Mycoplasma genitalium, as well as five mutations known to confer resistance to macrolide antibiotics. Macrolide-resistant M. genitalium is a challenging sexually transmitted infection (STI), and global management guidelines are currently being adapted to deal with the rise in resistance. "This is an important product in our portfolio," said Elisa Mokany, Chief Technology Officer for SpeeDx. "M. genitalium is very difficult to culture, and positive material for quality control can be hard to come by."  

SpeeDx's  Resistance Plus MG assay is the first commercially available diagnostic test that simultaneously detects M. genitalium and genetic markers for antimicrobial resistance, and has been widely adopted across Europe, Australia and New Zealand since gaining CE marking in 2016. "We have a strong focus on tackling the global antimicrobial resistance problem," said Colin Denver, CEO of SpeeDx. "STIs are set to become the first incurable bacterial infections, and our  Resistance Plus line of diagnostic tests empowers clinicians to make informed treatment decisions."

About Mycoplasma genitalium

M. 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 gonorrhoea. Like gonorrhoea, M. genitalium is 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 treatments for the rapidly growing problem of M. genitalium STIs, but resistance to these antibiotics has increased by up to 60 percent in several countries. This development led guidelines on M. genitalium infections in Europe and Australia recommending the molecular detection of M. genitalium be complemented with an assay capable of detecting macrolide resistance-associated mutations.

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. Currently, SpeeDx markets the only CE-marked and TGA approved commercial molecular test for the STI M. genitalium(ResistancePlus® MG*) that combines detection of the disease with detection of markers for antibiotic resistance. 
For more information about SpeeDx please see: http://plexpcr.com

*  Not available in the US

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

Tenaris to Acquire IPSCO Tubulars from TMK22.3.2019 13:58:00 CETPressemelding

LUXEMBOURG, March 22, 2019 (GLOBE NEWSWIRE) -- Tenaris S.A. (NYSE, Buenos Aires and Mexico: TS and MTA Italy: TEN) announced today that it has entered into a definitive agreement to acquire from PAO TMK, a Russian company and manufacturer of steel pipe, 100% of the shares of its wholly owned U.S. subsidiary IPSCO Tubulars, Inc., for US$1,209 million, on a cash-free, debt-free basis, which includes US$270 million of working capital. The transaction is subject to regulatory approvals, including approval by the U.S. antitrust authorities, and other customary conditions. IPSCO Tubulars is a U.S. domestic producer of seamless and welded OCTG and line pipe products, with an annual production capacity of 450,000 metric tons of steel bars, 400,000 metric tons of seamless pipe and 1,000,000 metric tons of welded pipe, and production facilities spread throughout the country. The acquisition would enhance Tenaris’s position and local manufacturing presence in the U.S. market, extending its produc

Oxford Immunotec Announces Chief Financial Officer Transition21.3.2019 21:01:00 CETPressemelding

OXFORD, United Kingdom and MARLBOROUGH, Mass., March 21, 2019 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq:OXFD) (the "Company"), a global, high-growth diagnostics company, today announced that Richard Altieri, the Company’s Chief Financial Officer (CFO), will retire on April 30, 2019. The Company has appointed Matthew McLaughlin, currently Chief Financial Officer, GE Healthcare – U.S. and Canada, as his successor. Mr. McLaughlin will join Oxford Immunotec as CFO on April 8, 2019. Today’s announcement concludes an extensive search process conducted by the Company. As part of the planned succession, Mr. Altieri, who has led Oxford Immunotec’s global finance organization as CFO since 2012, will remain an active member of the Company’s management team until his retirement date. “During his seven year tenure, Rick successfully managed multiple financing rounds, including the Company's IPO, the acquisition and financial integration of three companies and, most recently, the dives

Blackhawks, Flyers, Sabres and Lightning Headline the 2019 NHL Global Series21.3.2019 15:34:00 CETPressemelding

Chicago Blackhawks and Philadelphia Flyers to Open Regular Season in Prague, Czech Republic on Oct. 4 Buffalo Sabres and Tampa Bay Lightning to Face Off in a Pair of Games in Stockholm, Sweden on Nov. 8 and Nov. 9 2019 NHL Global Series Challenge to feature Blackhawks vs. Eisbären Berlin on Sept. 29 in Berlin, Germany and Flyers vs. Lausanne HC on Sept. 30 in Lausanne, Switzerland Tickets to Games in Berlin, Prague and Stockholm Available for Purchase on Wednesday, March 27; Tickets to Game in Lausanne Available for Purchase on Wednesday, April 10 NEW YORK/TORONTO, March 21, 2019 (GLOBE NEWSWIRE) -- The National Hockey League (NHL) and the National Hockey League Players’ Association (NHLPA), in conjunction with Live Nation Sweden, today announced that the Buffalo Sabres, Chicago Blackhawks, Philadelphia Flyers and Tampa Bay Lightning will participate in the 2019 NHL Global Series. The Chicago Blackhawks and Philadelphia Flyers will play their 2019-20 season-opening game against each ot

Farmako: World's Largest Import Contract for Pharmaceutical Cannabis21.3.2019 15:10:00 CETPressemelding

German Farmako secures 50 tonnes of flowers and oils from Polish company Pharmacann Polska FRANKFURT, March 21, 2019 (GLOBE NEWSWIRE) -- Farmako will import 50 tonnes of pharmaceutical cannabis from Pharmacann Polska into the European market over the next four years. This provides the basis for a reliable supply of pharmaceutical cannabis for millions of patients in the European healthcare system. The company expects a total revenue of several hundred million Euros from the agreed exclusive partnership. Founded in September 2018, Farmako now has grown to 40 employees and is distributing high-quality pharmaceutical cannabis to German pharmacies since March 2019. This is the biggest Cannabis contract to date, and the first big contract without participation of a Canadian LP. Farmako has signed an exclusive and binding agreement to import and distribute 50 tons of pharmaceutical cannabis over four years. Farmako and Pharmacann Polska enter strategic partnership to develop custom tailored

NexOptic Appoints Rich Geruson, Former Lexmark CEO, to Board of Directors21.3.2019 14:00:00 CETPressemelding

VANCOUVER, British Columbia, March 21, 2019 (GLOBE NEWSWIRE) -- NexOptic Technology Corp. ("NexOptic" or the "Company") (TSX VENTURE: NXO) (OTCQX: NXOPF) (FRANKFURT: E3O1) is pleased to announce that Richard J. (Rich) Geruson has joined its Board of Directors, effective immediately. Mr. Geruson’s experience spans CEO roles at Lexmark International, Phoenix Technologies and VoiceSignal Technologies, and Senior Vice President and executive positions at Nokia, IBM, Toshiba, and McKinsey & Co. As CEO of Lexmark International, a multibillion-dollar imaging technology and solutions company with 10,000 employees, he grew printer sales faster than at any time in the preceding 10 years while simultaneously executing extensive process reengineering, transforming the business from negative EBITDA and high debt to positive multi-hundred-million-dollar EBITDA and a healthy debt profile. While CEO of Phoenix Technologies, he achieved consistently high profit year-over-year for six years straight in