Business Wire

SpeeDx and Cepheid Announce Test Partnership

Del

SpeeDx Pty, Ltd. announced an agreement with Cepheid to manufacture their market-leading ResistancePlus ® tests for use on the GeneXpert System. The first test in Cepheid’s FleXible Cartridge programme, planned for launch early 2019, is ResistancePlus ® MG, detecting the sexually transmitted infection (STI) Mycoplasma genitalium (Mgen) and markers associated with azithromycin resistance.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190415005919/en/

ResistancePlus MG will be the first assay available through the Cepheid FleXible for GeneXpert progr ...

ResistancePlus MG will be the first assay available through the Cepheid FleXible for GeneXpert program.

“The availability of ResistancePlus MG in a FleXible cartridge that runs on the GeneXpert System is a compelling and exciting extension for us,” said Colin Denver, CEO of SpeeDx. “Patients are already benefiting from Resistance Guided Therapy with our central lab tests. Now clinicians can receive resistance information even faster, to support antimicrobial stewardship and more effective antibiotic treatment decisions.”

“Our new FleXible Cartridge program allows Trusted Reagent Manufacturers to develop targeted molecular tests using Cepheid’s easy-to use-cartridge.” said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. “With a global installed base of nearly 22,000 GeneXpert Systems, this technology could potentially be applied in multiple settings in which actionable treatment information is needed quickly.”

Management guidelines for Mgen infection include resistance testing1-3 in response to rising rates of macrolide resistance observed with Mgen detection-only or empiric Mgen treatment.4-6 ResistancePlus ® MG supports Mgen management guidelines and allows for Resistance Guided Therapy, which is clinically proven to improve cure rates by providing clinicians with much needed information to guide antibiotic treatment.3

About Mgen

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 gonorrhea. 7 Like gonorrhea, 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.8

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.4-6 Due to this growing antibiotic resistance problem, several global STI Management Guidelines on Mgen Infections recommend complementing the use of molecular testing to detect M. genitalium with an assay capable of detecting macrolide resistance-associated mutations.1-3

Currently, there is no FDA-cleared molecular diagnostic test for the detection of M. genitalium in the U.S. 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 Resistance Guided Therapy for better treatment of the disease for patients, lessening the potential for spreading among vulnerable populations and combating 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

About Cepheid

Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit www.cepheid.com.

1. Jensen JS, Cusini M, Gomberg M, Moi H. 2016. 2016 European guideline on Mycoplasma genitalium infections. J Eur Acad Dermatol Venereol. PMID: 27505296.
2. https://www.bashhguidelines.org/media/1146/ngu-update-05_2017-final.pdf
3. http://www.sti.guidelines.org.au/sexually-transmissible-infections/mycoplasma-genitalium
4. 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
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. 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.
8. Unemo, M. & Jensen, J.S. ‘Antimicrobial-resistant sexually transmitted infections: gonorrhoea and Mycoplasma genitalium’. 2016. Nat. Rev. Urol.268. Published online 10 Jan 2017. doi:10.1038/nrurol

Contact information

SpeeDx:
Europe, Australia, New Zealand:
Madeline O’Donoghue
+61 2 9209 4170
madelineo@speedx.com.au

USA:
Rick Roose
+1 415.202.4445
roi.roose@gmail.com

Cepheid:
Darwa Peterson
darwa@cepheid.com
Tel. + 1.408.400.4324

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Nordson EFD Introduces the Contact versus Jet Dispensing White Paper25.4.2019 12:16:00 CESTPressemelding

Nordson EFD , a Nordson company (NASDAQ: NDSN), the world’s leading precision fluid dispensing systems manufacturer, is pleased to introduce its Contact vs. Jet Dispensing white paper. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190425005027/en/ As products continue to get smaller and smaller, Nordson EFD has developed new solutions to address this growing need to apply precise, repeatable micro-deposits of assembly fluids in production processes worldwide. “We understand the challenges manufacturers face when their process requires bonding tiny substrates and components together,” said Peter Langer, Business Unit Director of Valves at Nordson EFD. “The deposit tolerance requirements are considerable. And there are a number of variables to consider in order to choose the right dispensing method.” This white paper helps manufacturers understand the difference between two of the most common dispensing methods. Contact dispe

Hologic Launches Trident® HD Specimen Radiography System in United States, Canada and Europe25.4.2019 12:15:00 CESTPressemelding

Hologic, Inc. (Nasdaq: HOLX) today announced global commercial availability of the Trident® HD specimen radiography system, a next-generation solution that delivers enhanced image quality, improved workflow and instant sample verification during breast-conserving surgeries and stereotactic breast biopsies.1 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190425005180/en/ Trident® HD Specimen Radiography System (Photo: Business Wire) The Trident products are the only specimen radiographs on the market to use amorphous selenium direct capture imaging – the same detector technology used in Hologic’s 3Dimensions™ mammography system – to generate crisp, clear, high-resolution images. The new Trident HD system, which recently received FDA clearance in the US and a CE Mark in Europe, also features a bigger detector that allows for complete imaging of larger breast surgical specimens, along with a wide range of surgical and biopsy sa

Velodyne Lidar, Nikon Announce Manufacturing Agreement for Mass Production of Velodyne Lidar Sensors25.4.2019 12:00:00 CESTPressemelding

Velodyne Lidar, Inc. today announced an agreement with Nikon Corporation, under which Sendai Nikon Corporation, a Nikon subsidiary, will manufacture lidar sensors for Velodyne with plans to start mass production in the second half of 2019. The partnership cements Velodyne’s manufacturing plan and expands its lead in the global lidar sensor market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190425005236/en/ Velodyne provides the smartest, most powerful lidar solutions for vehicle autonomy and driver assistance. (Photo: Business Wire) “Mass production of our high-performance lidar sensors is key to advancing Velodyne’s immediate plans to expand sales in North America, Europe, and Asia,” said Marta Hall, President and CBDO, Velodyne Lidar. “With this partnership, Velodyne affirms its leadership role in designing, producing, and selling lidar for worldwide implementation. For years, Velodyne has been perfecting lidar technol

Gilead Announces Topline Data From Phase 3 STELLAR-3 Study of Selonsertib in Bridging Fibrosis (F3) Due to Nonalcoholic Steatohepatitis (NASH)25.4.2019 12:00:00 CESTPressemelding

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that STELLAR-3, a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib, an investigational, once daily, oral inhibitor of apoptosis signal-regulating kinase 1 (ASK1), for patients with bridging fibrosis (F3) due to nonalcoholic steatohepatitis (NASH), did not meet the pre-specified week 48 primary endpoint of a ≥ 1-stage histologic improvement in fibrosis without worsening of NASH. In the study of 802 enrolled and dosed patients, 9.3 percent of patients treated with selonsertib 18 mg (p=0.42 versus placebo) and 12.1 percent of patients treated with selonsertib 6 mg (p=0.93) achieved a ≥ 1-stage improvement in fibrosis according to the NASH Clinical Research Network (CRN) classification without worsening of NASH after 48 weeks of treatment, versus 13.2 percent with placebo. Selonsertib was generally well tolerated and safety results were consistent with prior studies. “While we

Forter Readies Merchants with Launch of PSD2-Compliant Solution25.4.2019 11:25:00 CESTPressemelding

Forter, the leading e-commerce fraud prevention company, today launches its PSD2-compliant merchant offering, Forter PSD2 Solution for Merchants . The comprehensive, payment processor-agnostic solution enables merchants to dynamically route customers to the path of least friction required, prevent all types of fraud and violations of business policies, and optimise the customer’s payment experience – all while meeting full PSD2 compliance. As of 14 September 2019, the revised Payment Services Directive (PSD2) introduces the requirement for merchants to authenticate online transactions within the European Economic Area using Strong Customer Authentication (SCA). Under SCA, merchants have to introduce additional friction into the purchasing process for customers, which will lead to increased drop-off rates, reduce overall conversion rates, and provide a poor customer experience. These changes could ultimately hurt revenue, so merchants must mitigate these challenges and minimise the impa

The Smarter E Europe – Explore Sector Coupling for Yourself at Europe’s Largest Platform for the Energy Industry25.4.2019 09:53:00 CESTPressemelding

The innovation hub The smarter E Europe, encompassing the exhibitions Intersolar Europe, ees Europe, Power2Drive Europe and EM-Power, was launched in 2018 and has seen impressive growth ever since. It will be held for the second time from May 15–17, 2019 at Messe München and will now cover 10 exhibition halls, making it Europe’s largest energy industry event. This growth is due in large part to the upward trend in renewable energies. Since 2010, the proportion of energy generated worldwide from renewable sources has risen from 20 to 25 percent. By 2030, we’re looking at a jump to around 60 percent. In Germany, an average of 45 percent of all electricity generated already came from renewables in the first quarter of 2019. This dynamism is stimulating innovation and shaping the modern energy industry. The buzzword of the hour is sector coupling – a unification of the previously independent electricity, heating and transportation sectors. For instance, a photovoltaic (PV) installation in