Verigene RP Flex Submitted to FDA

In December, Nanosphere submitted its new multiplex respiratory tract infection test, the Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex), to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. RP Flex is an automated, sample to result test for the identification of the most common viruses and bacteria that cause acute respiratory infections. […]

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Getting Ready for Flu Season

The fall season brings Americans cooler weather, football, pumpkin spice lattes, and, also, the dreaded flu. The seasonal flu vaccine protects against the influenza viruses that research indicates will be most common during the upcoming season. All of the available vaccine options this year were designed to protect against the following: […]

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Peer-to-Peer: Why My Lab Chose Verigene RP Flex

At last month’s Clinical Virology Symposium in Daytona Beach, FL, Angie Silva, MT(ASCP), Microbiology Manager at St. Mary’s Hospital in Grand Junction, CO, shared her experience working with Verigene® RP Flex (RUO) and her lab’s plans for implementing the test upon FDA clearance. Angie describes her decision making process in looking for a new cost-effective […]

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New Study in JCM Characterizes the Performance of the Verigene Clostridium difficile Test

A recent publication by Karen Carroll et al. in the Journal of Clinical Microbiology (JCM) characterized the performance of the Verigene® Clostridium difficile Nucleic Acid Test (CDF) by comparing CDF results versus both direct and enriched toxigenic culture on stool specimens from patients suspected of having C. difficile infection. A total of 1,875 specimens were analyzed in the multi-center study. […]

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CDC Reports 1 in 7 HAIs Caused by Antibiotic-Resistant Superbugs

A new report from the Centers for Disease Control and Prevention (CDC) shows that one in every 25 patients develops an infection during a hospital stay, with one in every seven of these infections being caused by a potentially deadly superbug. This one-in-seven statistic increases to one in four in longer term hospitals. […]

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Has Norovirus Gone Viral?

Norovirus often finds itself in the spotlight when it is the cause of a food-borne disease outbreak on a cruise ship; however, norovirus can be found lurking just about anywhere. With an estimated 20 million cases per year, norovirus is the most common cause of acute gastroenteritis in the US, leading to 71,000 hospitalizations and 800 deaths. […]

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Severe Norovirus Outbreak Underscores Need for Rapid Testing

A mass of norovirus cases linked to a Boston Chipotle this month is one of the biggest outbreaks of the virus in the US since 2009. To date, 80 illnesses have been confirmed by the Boston Public Health Commission, and another 140 Boston College students have come to the campus health center with suspected cases of norovirus. […]

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Experts Share Experience with Verigene Gram-Negative Blood Culture and Enteric Pathogens Tests

During a recent workshop that we hosted, Glen Hansen, Ph.D., and Elizabeth Marlowe, Ph.D., shared their respective experiences working with Verigene® infectious diseases tests. Dr. Hansen described the Verigene Gram-Negative Blood Culture (BC-GN) test and his view on the value of rapid ESBL and carbapenemase detection as the spread of antimicrobial resistance in gram-negative bacteria reaches the US. Dr. Marlowe discussed the Verigene Enteric Pathogens (EP) test and the value of molecular testing for community-acquired diarrhea. […]

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Commentary Highlights Advantages of Molecular Stool Testing

Over the past few months, we have shared a number of educational pieces that have described the challenges associated with conventional methodologies for the detection of community-acquired diarrheal illness and the potential benefits of rapid molecular tests. One commentary in particular that best speak to these matters include an editorial in Medical Laboratory Observer titled “The Changing Landscape of Diagnostic Testing for Diarrheal Disease.” This piece articulately summarizes the burden of diarrheal illness in the U.S., the limitations associated with conventional stool testing practices, and the value of molecular stool testing. […]

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Seven New Verigene Studies Presented at ASM 2015

Last month, seven studies evaluating the performance and clinical impact of select Verigene® multiplex infectious disease tests were presented at the 115th General Meeting of the American Society for Microbiology (ASM 2015), held in New Orleans, Louisiana. Three of these studies highlighted the superior performance and broad antibiotic resistance coverage of the Verigene Gram-Negative Blood Culture Test (BC-GN). […]

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