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Cepheid And Leading Pharma Companies Partner On A Diagnostic Test To Tackle Multidrug-Resistant Bacterial Infections

Cepheid announced a new collaboration with AstraZeneca, Cubist Pharmaceuticals, Inc., and GSK intended to promote transformational change in infectious disease therapy by developing a rapid diagnostic test that can target multi-drug resistant pathogens and support the appropriate use of antibiotics.  Targeting bacterial infections with the right treatment will slow the development of resistance that has led to a crisis in treating infections.

Xpert® Carba-R is a rapid test under development for use with rectal swab samples to identify the presence of potentially life threatening bacteria.  Specifically, the consortium is working to extend the number of body sample types from rectal swabs to other body samples such as respiratory samples from patients with pneumonia.  Xpert Carba-R is commercially available outside the US, and is targeted for commercial release in the US in 2015, subject to regulatory approval.

According to a 2013 report by the US Centers for Disease Control and Prevention1 (CDC), up to 50% of all antimicrobial agents that are prescribed are unnecessary or are not likely to be effective as prescribed.  This has contributed to the emergence and spread of multiple species of bacteria that are resistant to many, and in some cases all, of the antimicrobial agents that are available for therapy.  In the United States alone, more than 2 million people each year acquire a serious bacterial infection that is resistant to one or more of the antimicrobial agents intended to treat it.

"There is clearly a need to identify patients with multidrug-resistant infections more rapidly and provide them with more potent antimicrobial agents, especially those that are active against multidrug resistant organisms," said Dr. Fred Tenover, Cepheid's Vice President for Scientific Affairs and former Director of CDC's Office of Antimicrobial Resistance.  "Once available, our Xpert Carba-R test could prove to be a valuable tool as the fight against multidrug resistant infections intensifies.  Cepheid is very pleased to be working with these distinguished pharmaceutical partners to meet their diagnostic needs, reduce the complexity of clinical trials, and accelerate the approval of these much needed anti-infective compounds."

Manos Perros, Vice-President and Head of AstraZeneca Infection Innovative Medicines added, "Developing rapid molecular diagnostics will enable physicians to treat patients suffering from bacterial infections with a new generation of safe and well tolerated antibiotics that will target drug-resistant pathogens in an effective way that is not possible with today's drugs.  The work of this consortium will generate diagnostics which we can use to match the right drug to the patient, help develop our emerging pipeline of pathogen-targeted antibacterials, and step up the fight against the threat of antibacterial resistance."

"Antibiotic resistance is a serious health crisis that demands immediate attention.  We need both to significantly improve our management of current antibiotics while also investing aggressively in new antibiotics to address these emerging threats," said Lorianne K. Masuoka, M.D., Senior Vice President, Clinical Development and Medical Affairs, and Chief Medical Officer of Cubist.  "A comprehensive and targeted approach combining rapid diagnostics with antibiotics will advance efforts to treat the right patients at the right time at the right dose and duration."

Concluding, Linda A. F. Miller, Ph.D., Director of Diagnostics and Clinical Microbiology for GSK Antibacterial R&D, stated, "Bacteria have responded to antibacterial drugs by developing resistance. To make sure we do not go back to the pre-antibiotic era where simple infections were very dangerous and many current hospital procedures and treatments would be impossible, we need to more effectively use the antimicrobials we have and we need to develop new medicines.  Accurate, rapid, easy to use diagnostic tests that can identify infecting pathogens directly from a patient sample will alter the way we treat bacterial infections by allowing us to enhance the efficiency of clinical trials and provide physicians with test results prior to making critical treatment decisions.  GSK enthusiastically supports the steps we are taking together with Cepheid, AZ and Cubist to help move us toward a new era in the development and use of antibacterial medicines."

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