Diagnostic Test Being Developed for Multidrug-Resistant Pathogens

A consortium has been formed to promote transformational change in infectious disease therapy by developing a rapid diagnostic test that can target multidrug-resistant pathogens and support the appropriate use of antibiotics.

Cepheid (Sunnyvale, CA, USA) has entered into collaboration with AstraZeneca (London, United Kingdom), Cubist Pharmaceuticals, Inc., (Lexington, MA, USA) and GSK (Brentford, Middlesex, United Kingdom) with the aim of promoting transformational change in infectious disease therapy. 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 intended for commercial release in the US in 2015, subject to regulatory approval.

The US Centers for Disease Control and Prevention (CDC; Atlanta GA, USA), reported in 2013 that up to 50% of all antimicrobial agents that are prescribed are unnecessary or are unlikely 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.

Dr. Fred Tenover, Cepheid's vice president for Scientific Affairs and former director of CDC's Office of Antimicrobial Resistance, said, "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. Once available, our Xpert Carba-R test could prove to be a valuable tool as the fight against multidrug resistant infections intensifies."

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, MD, senior vice president, Clinical Development and Medical Affairs, and CMO 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."

Linda A. F. Miller, PhD, 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."

Cepheid is a 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.

AstraZeneca is a biopharmaceutical business that focuses on the discovery, development, and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection, and neuroscience diseases.

Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address significant unmet medical needs in the acute care environment.

GSK is a research-based pharmaceutical and healthcare company committed to improving the quality of human life by enabling people to do more, feel better and live longer.

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Cubist Pharmaceuticals, Inc.