SYDNEY -- (BUSINESS WIRE) --

First sentence, seventh paragraph of release dated April 16, 2019 should read: “Currently, there is no FDA-cleared molecular diagnostic test for the combined detection of M. genitalium and macrolide resistance markers in the U.S. Cure rates for M.genitalium have been shown to be in decline in recent studies; however, a groundbreaking paper using ResistancePlus MG as part of a Resistance Guided Therapy protocol reported significant increases in cure rates to over 92%.⁴”

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The corrected release reads:

SPEEDX AND CEPHEID ANNOUNCE TEST PARTNERSHIP

SpeeDx tests will be available through Cepheid’s FleXible Cartridge programme for the GeneXpert System

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.

“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 testing^1-3 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 combined detection of M. genitalium and macrolide resistance markers in the U.S. Cure rates for M.genitalium have been shown to be in decline in recent studies; however, a groundbreaking paper using ResistancePlus MG as part of a Resistance Guided Therapy protocol reported significant increases in cure rates to over 92%.⁴ 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

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CONTACT:

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

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