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Respiratory Virus Panel from GenMark Diagnostics Receives FDA Clearance

GenMark Diagnostics
18 Sept 2012
Sonia Nicholas
Managing Editor and Clinical Lead

Product news

GenMark Diagnostics, Inc., a provider of automated, multiplex molecular diagnostic testing systems, has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its eSensor® Respiratory Virus Panel for use on its XT-8 system.

The test is intended to simultaneously detect and differentiate 14 clinically relevant viruses from patients with influenza-like illness. The eSensor® RVP test has the potential to significantly improve patient care by delivering superior co-infection detection, distinguishing Rhinovirus from Enteroviruses and identifying clinically relevant Adenoviruses.

Compared to other multiplex respiratory viral panels, the eSensor® RVP test delivers superior sensitivity and laboratory efficiency. With rapid processing and minimal hands-on time required from laboratory staff, GenMark’s eSensor® RVP test enables clinical laboratories to rapidly report actionable patient results to physicians, while efficiently managing the fluctuating testing workload associated with this seasonal illness.

“The FDA clearance of our eSensor® Respiratory Virus Panel test further demonstrates the capability of our uniquely differentiated electronic detection technology,” commented Hany Massarany, GenMark’s President and CEO. “The FDA review process, which was both collaborative and thorough, resulted in a 510(k) clearance which supports performance claims that we believe will meet customer needs and expectations, especially with regard to specificity, sensitivity and limits of detection,” Mr. Massarany continued.

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Genome AnalysisGenomics, the study of genomes, includes functional genomics, evolutionary genomics and comparative genomics. There are many genomic technologies such as DNA sequencing of whole genomes, computational biology and bioinformatics. DNA and nucleic acids must be isolated and concentrated from cells for analysis with kits, automated analyzers and software. Other useful technologies for studying genomics include PCR, microarrays and electrophoresis.MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Clinical GeneticsMolecular Genetics covers the analysis of hereditary genetic disease and chromosomal abnormalities. Genetics can be analysed using DNA, RNA, and protein microarrays, PCR, RT PCR and DNA sequencing. Genetic equipment includes genetic workstations, thermal cyclers, cooling blocks and electrophoresis products. Diagnostic kits are used for DNA / RNA extraction and purification.Clinical MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Respiratory InfectionsRespiratory infections are caused by pathogens such as bacteria, viruses, and fungi, leading to diseases like pneumonia, tuberculosis, and COVID-19. It is important to identify respiratory infections quickly in patients to ensure appropriate treatment and care, and to prevent sepsis. Browse our peer-reviewed product directory to find the best tools for respiratory infection detection, compare products, check reviews, and get pricing directly from manufacturers.VirusesViruses are microscopic pathogens that require a host cell to replicate. Understanding their structure, replication cycle, and impact on the immune system is crucial in developing effective treatments, vaccines, and diagnostic methods. Research continues to focus on emerging viral diseases and antiviral drug discovery. Explore solutions for virus research, detection, and treatment in our peer-reviewed product directory; compare products, check customer reviews, and get pricing directly from manufacturers.MultiplexingMultiplexing refers to the ability to measure multiple targets or analytes simultaneously in a single experiment. This technique is valuable for high-throughput screening, diagnostics, and complex assays, as it increases efficiency and data quality. Browse our peer-reviewed product directory to find the best multiplexing products, compare tools, check reviews, and get pricing directly from manufacturers.

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