SpeeDx and Cepheid Announce Test Partnership

Ad blocking detected

Thank you for visiting CanadianInsider.com. We have detected you cannot see ads being served on our site due to blocking. Unfortunately, due to the high cost of data, we cannot serve the requested page without the accompanied ads.

If you have installed ad-blocking software, please disable it (sometimes a complete uninstall is necessary). Private browsing Firefox users should be able to disable tracking protection while visiting our website. Visit Mozilla support for more information. If you do not believe you have any ad-blocking software on your browser, you may want to try another browser, computer or internet service provider. Alternatively, you may consider the following two offers if you want an ad-free experience.

Canadian Insider Club
$299/ year*
Daily Morning INK newsletter
+3 months archive
Canadian Market INK weekly newsletter
+3 months archive
30 publication downloads per month from the PDF store
Top 20 Gold, Top 30 Energy, Top 40 Stock downloads from the PDF store
All benefits of basic registration
No 3rd party display ads
10-day money back guarantee*
JOIN THE CLUB
Canadian Insider Ad-Free
$49/ year*
All benefits of basic registration
No 3rd party display ads
10-day money back guarantee*
GO AD-FREE

* Price is subject to applicable taxes. Money back guarantee: For bona fide Ad-Free or Canadian Insider Club subscribers, if you downgrade to Basic or cancel with-in 10 days of first subscribing, we will refund your payment upon request. Immediately after downgrading or cancelling, using the same email that is associated with your account, request a refund via our Contact Us form at the bottom of the page. We will only consider one refund request per household or organization. We cannot accommodate refund requests where an account holder has not provided verifiable address and billing information.

Paid subscriptions and memberships are auto-renewing unless cancelled (easily done via the Account Settings Membership Status page after logging in). Once cancelled, a subscription or membership will terminate at the end of the current term.

Apr 16, 2019 02:00 am
SYDNEY -- 

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

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

Comment On!

140
Upload limit is up to 1mb only
To post messages to your Socail Media account, you must first give authorization from the websites. Select the platform you wish to connect your account to CanadianInsider.com (via Easy Blurb).