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PrimeraDx Receives CE Marks for the ICEPlex System and C. difficile Detection Assay

12 Sept 2012
Sonia Nicholas
Managing Editor and Clinical Lead

Product news

PrimeraDx, a molecular diagnostics company, announced today that the ICEPlex system, a quantitative multiplex PCR system, and their C. difficile detection assay have both received the CE mark.

"Obtaining the CE mark on our instrument and assay is an important step in the process of global commercialization of our extensive pipeline of molecular diagnostics products in infectious disease and oncology," said CEO and President Matt McManus. Dr. McManus continued, "The CE mark demonstrates to current and future customers, and strategic partners, our ability to develop and support high quality diagnostic products."

The ICEPlex system consists of a platform on which PrimeraDx develops high multiplex, quantitative, molecular diagnostic products. These products span multiple clinical areas including infectious disease, oncology and companion diagnostics. The system's unique ability to test for many different target types "all in one well" is critical to satisfying the next generation of clinical diagnostic needs.

C. difficile is one of the common and deadly hospital-acquired infections and is linked to about 14,000 US deaths annually, according to the Centers of Diseases and Prevention Controls. The ICEPlex C. difficile assay is a molecular diagnostic test for the detection of the Clostridium difficile. Based on a novel, game-changing clinical platform which combines PCR with capillary electrophoresis, the ICEPlex C. difficile Assay is performed on nucleic acids purified from human stool samples.

"The two CE Marks, and our previously announced ISO 13485:2003 certification demonstrate our commitment and ability to develop regulated molecular diagnostic products," added Fayyaz Memon, Vice President of Regulatory Affairs and Quality Assurance.

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PCR and Thermal CyclingPolymerase chain reaction (PCR) kits and thermal cyclers are used for the in vitro amplification of DNA permitting subsequent analysis and experimental procedures. Explore a range of high-quality polymerase, primers and nucleotides or simplify your workflow with a PCR mastermix. Find reverse transcription PCR (RT-PCR) and cDNA synthesis kits for RNA products and libraries. Quantitatively measure the amplification of DNA with real-time PCR (qPCR) and droplet digital PCR (ddPCR) kits and systems, and discover automated PCR setup solutions to increase throughput. Alternative DNA amplification methods also include recombinase polymerase amplification (RPA) kits. Find the best PCR kits and thermal cyclers and purification equipment 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.Companion DiagnosticsCompanion diagnostics are tests, often <i>in vitro</i>, that are used to determine whether a therapeutic product will be safe and effective for use on an individual. They also identify which patients will benefit most from them. Companion diagnostic tests are often developed in conjunction with the pharmaceutical industry.Clinical MultiplexingClostridium difficile

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