The QuantStudio 5 Dx Real-Time PCR System is listed with the FDA, includes the CE-IVD Mark under the self-certification process in the European Union, and has been certified and approved by the National Medical Products Administration (NMPA) in China. Both the QuantStudio Dx and QuantStudio 5 Dx offer the flexibility of customizable solutions and provide high-quality data output for molecular diagnostic testing." " Thermo Fisher's QuantStudio qPCR systems offer a seamless integration into our assay development workflows. " Thermo Fisher is a valued partner, supporting us in the development of clinical trial assays and companion diagnostics," said Michael Sloan, global vice president of commercial operations at Almac Diagnostic Services. The cost-effective and complete solution, including simplified software, enhanced security and a simple-to-use interface, comes in a compact footprint that can fit in any lab. The system has high sensitivity and specificity and offers up to six channels for multiplexing. The high-performing qPCR system's simplified, efficient workflow minimizes steps to deliver quality results in as little as 30 minutes. With the launch of the IVD QuantStudio 5 Dx, we can continue to support our customers around the world." "As our customers' testing requirements grow, we are continuously innovating to meet their needs with our molecular diagnostic products. "The COVID-19 pandemic has increased testing demands for laboratories exponentially, with a significant portion of the testing globally conducted on Thermo Fisher PCR instruments," said Mark Smedley, president of Genetic Sciences for Thermo Fisher Scientific. These laboratories are now seeking solutions to continue to screen for COVID-19 after emergency use authorizations (EUAs) for SARS-CoV-2 assays expire. The innovative product enables clinical laboratories and assay developers to meet testing demands and enhance their molecular diagnostics workflows.Ĭlinical diagnostic and hospital laboratories across the United States have ramped up PCR testing over the last year in response to the global COVID-19 pandemic. Food and Drug Administration (FDA) listing for the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System. The US Food and Drug Administration has listed the QuantStudio 7 Pro Dx Real-Time PCR System as a class II medical device, Thermo Fisher added.CARLSBAD, Calif., Ma/PRNewswire/ - Thermo Fisher Scientific today announced the completion of the U.S. Other key system features include: security, auditing, and e-signature functionalities to assist in compliance with regulatory requirements and support multiple clients software designed to guide users through workflow steps for test development or IVDs the ability to create and manage assay definition files (ADFs) for a specific assay, panel, or test that incorporate all of the qPCR setup and analysis parameters required for a particular assay a small footprint that doesn't require an attached computer, with a graphical user interface that enables end-to end workflows from the touchscreen a six- color, decoupled OptiFlex filter system with bright white LED hands-free functionality to enable the performance basic operations using voice commands and smart support and smart help to report issues or request instrument services to reduce downtime.The system also uses up to 54 percent less material, generates 91 percent less waste during calibration, and uses up to 26 percent less energy than comparable instruments, the company said. Designed to support in vitro diagnostic applications and the development of molecular diagnostic assays, the QuantStudio 7 Pro Dx system has sensitivity down to 1.5-fold in singleplex reactions and 10 logarithmic units of linear dynamic range. The platform supports interchangeable 96-well and 384-well blocks and automation compatibility, and for molecular laboratories developing and running their own tests, there are embedded regulatory controls to support traceability and reduce the risk of unauthorized use or potential misuse. Thermo Fisher Scientific has launched the Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System, a standalone qPCR platform that the company said is versatile, highly expandable, and easy to use. Advances in Clinical Genomics Profiling.
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