Bio-Rad Laboratories recently announced CE IVD marking for its QX200 Droplet Digital PCR (ddPCR) System, the first digital PCR system for in vitro diagnostic (IVD) use in the European Union. With the CE IVD mark, medical practitioners in Europe can use the QX200 system for highly-accurate detection and quantification of nucleic acids, aiding clinical decision-making in the treatment of diseases ranging from cancer to transplant rejection and viral infection. As a diagnostic tool, the system is fast and cost-effective, making it ideal for realizing the promise of precision medicine. One aspect of cancer precision medicine that will be rapidly influenced by the QX200 ddPCR System is liquid biopsy, an increasingly popular technique used to non-invasively genotype tumours, track treatment efficacy, and predict cancer recurrence. This form of biopsy shows great promise for guiding treatment decisions. Prospective trials are currently underway to evaluate the effectiveness of liquid biopsy in a clinical setting and, specifically, the utility of combined Droplet Digital PCR and next generation sequencing in analysing genomic alterations. Since 2011, Droplet Digital PCR has been available for research use only. The technology, which partitions a DNA or RNA sample into 20,000 droplets and amplifies targeted sequences within each droplet, allows scientists to precisely detect and quantify low concentrations of target DNA and RNA sequences. This enables a range of important genomic applications, including cancer mutation detection, gene copy number determination, viral load monitoring, and gene edit detection.
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Addressing the challenges faced by point-of-care (POC) coordinators in the laboratory, the Ecosystem is an integrated component of the RAPIDComm Data Management System, an informatics solution which centrally manages Siemens in vitro diagnostic analysers and operators. The system encompasses eight core components including device management, operator management, quality control, compliance reporting, competency management, inventory management, remote monitoring and mobile access. POC testing continues to grow at a rapid pace and there is a strong need to provide fast and reliable results in order to improve patient outcomes and optimize clinical workflow. Although solutions for each of the eight core components do exist individually, efficiently managing all aspects of a POC testing programme requires close collaboration among hospitals, device manufacturers and IT vendors. The Siemens POC Ecosystem helps to address this challenge by implementing an integrated solution which improves the efficiency and effectiveness of POC programmes. The Ecosystem solution manages secure access to POC devices, oversees quality control, manages staff training plus identifies and resolves issues from any location via the remote access facility. This helps to ensure the manageability of instruments and consumables for potentially hundreds of testing devices throughout a Trust. External compliance requirements are also met while reducing costs and improving efficiencies. Ecosystem takes the core needs of a POC programme into consideration with a focus on helping POC coordinators improve control, effectiveness and transparency. The Ecosystem solution allows POC data management from anywhere within a hospital using tablets and smart phone, which improves the ability of POC coordinators to quickly and efficiently resolve issues.
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A compact, affordable and efficient instrument, the SK500 Chemistry System offers a broad menu of high quality SEKURE reagents for the benefit of physicians’ office or hospital laboratory. The SK500 has a throughput of up to 580 tests/hour with ISE, 72 patient sample on-board capability, minimizes the use of water (13L/day) and has 36 onboard assays (+3 ISE) to meet the testing needs of small-to-moderate volume laboratories.  A simple and intuitive interface requires minimal training, and utilization of primary tubes and cups allows for easy deployment.

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BioFire Diagnostics’ FilmArray Meningitis/ Encephalitis (ME) Panel is now available in the countries which recognize CE marking. The ME Panel provides highly beneficial medical value, as it addresses the critical unmet need for quick and accurate identification of central nervous system (CNS) infectious agents. The comprehensive ME Panel tests cerebrospinal fluid (CSF) for the 14 most common pathogens (6 bacteria, 7 viruses and 1 yeast) responsible for community acquired meningitis or encephalitis in about an hour. Currently, testing CSF for multiple organisms can take days and is not always possible because it can be difficult to obtain enough fluid from each patient to run multiple tests.
The ME Panel received a de novo clearance by the U.S. Food and Drug Administration (FDA) in October 2015. The ME Panel brings a unique opportunity to test simultaneously and rapidly for most bacteria, viruses and fungi found in those pathologies that can be extremely severe and sometimes lethal. Such an approach will positively impact the management of those patients by helping clinicians and biologists speed the diagnosis of these potentially severe conditions and make much faster decisions on appropriate therapy to prevent complications. More than 1.2 million people every year are affected by meningitis worldwide, resulting in 120,000 deaths globally from bacterial meningitis. Bacterial meningitis can occur suddenly in healthy people and even with prompt diagnosis and treatment, approximately 10% of patients may die and up to 20% or more may sustain permanent damage and disability. The ME Panel is cleared for the FilmArray and FilmArray 2.0 systems and is commercially available around the globe.
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