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Hologic's Panther Fusion Bordetella Assay Now CE Marked in Europe

Hologic, Inc.
10 Oct 2018
Finn Price
Administrator / Office Personnel

Product news

Hologic, Inc. has announced that its Panther Fusion® Bordetella assay has received CE mark in Europe. This assay, the latest in a growing menu of Panther Fusion® and Aptima® assays, brings full automation, efficiency and excellent assay performance to Bordetella detection. The Panther Fusion system retains all the key benefits of the Panther platform, including full sample-to-result automation, and is suitable for any size laboratory.

The Panther Fusion® Bordetella assay is a real-time PCR assay for the detection and differentiation of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) from nasopharyngeal swab specimens collected from symptomatic patients. Bordetella pertussis is the bacteria associated with “Whooping cough,” one of the 52 notifiable communicable diseases in the European Union.

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“The launch of the Panther Fusion® Bordetella assay expands the portfolio of respiratory assays available for Panther Fusion, enabling our European customers to deliver a better service to their clients and ultimately to patients,” said João Malagueira, Hologic’s VP Diagnostics, EMEA. “The assay accurately detects and differentiates Bordetella pertussis and parapertussis, ensuring the physician can select the appropriate antibiotic treatment for their patient.”

The Panther Fusion® Bordetella assay enables laboratory customers to leverage the benefits of the fully automated Panther Fusion system, which provides random and continuous access to improve laboratory efficiency. Laboratories can combine cervical and sexual health, virology, respiratory, hospital-acquired infections, and Open Access® tests on the Panther Fusion system, running up to 32 different assays at the same time. The system offers labs the potential to process up to 500 Panther Fusion and Aptima assays in an 8-hour period.

Panther Fusion is available as a full system, or the Panther Fusion module can be attached to existing Panther systems in the field to extend testing capabilities. The Panther Fusion module adds the capacity to run PCR (polymerase chain reaction) assays in addition to tests based on TMA (transcription-mediated amplification), the proprietary Hologic chemistry that powers the Company's Aptima® brand. Key system benefits include the ability to run multiple tests from a single sample, random and continuous access, sample processing with rapid turnaround time, continuous loading, and STAT capabilities. The Panther Fusion assays utilize ready to use, unit-dose lyophilized reagents, which have 60-day on-board stability to help reduce waste and the need for manual reagent preparation.

Diagenode, a leading diagnostics assay provider based in Liege, Belgium and New Jersey, USA, was a principal partner in developing the Panther Fusion Bordetella assay in collaboration with Hologic, and is the manufacturer of the kit.

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Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.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.RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. 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.BacteriaBacteria are microorganisms that play critical roles in the environment, human health, and biotechnology. Understanding bacterial genetics, growth, and metabolism is essential for developing antibiotics, vaccines, and improving industrial processes. Browse our peer-reviewed product directory to find the best bacterial research tools, compare products, check reviews, and get pricing directly from manufacturers.Clinical ChemistryClinical chemistry involves the analysis of bodily fluids, like blood and urine, to diagnose and monitor diseases. Tests in clinical chemistry provide critical information for patient care and treatment decisions. Explore clinical chemistry tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.Assay DevelopmentThe process of proving an assay to be sensitive with respect to the target is known as assay development. The assay should be able to characterize novel compounds and measure the potency of these compounds against a validated biological target.In Vitro DiagnosticsIn vitro diagnostics (IVD) involve testing samples outside the body, typically in a laboratory, to diagnose diseases or conditions. IVD technologies include blood tests, molecular assays, and other bodily fluid tests, enabling accurate diagnosis and monitoring of diseases. These tests are essential for guiding treatment decisions in clinical settings. Browse our peer-reviewed product directory to find the best IVD solutions; compare products, check reviews, and get pricing directly from manufacturers.Microbiology

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Hologic's Panther Fusion Bordetella Assay Now CE Marked in Europe