Quantstudio 5 Real Time Pcr – The IVDR-compliant QuantStudio 5 Dx system simplifies molecular diagnostic workflows in infectious disease and oncology. (Photo: Work Wire)
CARLSBAD, California–(BUSINESS WIRE)–To help molecular diagnostic manufacturers and clinical testing labs comply with the higher in vitro diagnostic requirements (IVDR) standards currently in force in the European Union, Thermo Fisher Scientific is partnering with Applied Biosystems QuantStudio worldwide. 5 Dx Real Time PCR System. The innovative qPCR system simplifies molecular diagnostic workflows in infectious disease and oncology.
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Molecular diagnostic kit manufacturers and clinical testing laboratories developing their own assays need open qPCR platforms that meet IVDR requirements. The IVDR compliant QuantStudio 5 Dx system will enable molecular diagnostics manufacturers to develop new IVDR compliant tests in accordance with the new regulations. The system will also help clinical laboratories conducting diagnostic tests transition to IVDR qPCR testing.
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“Molecular diagnostic manufacturers and laboratories that do not have instruments and tests that have been properly validated and CE marked may face delays under new IVDR regulations,” said Marty Murawski, vice president of regulation and quality assurance at Thermo Fisher Scientific. “We are committed to helping our customers maintain high standards of patient safety, meet new requirements, and obtain appropriate certifications to remain competitive in today’s market. By aligning the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System IVDR, A high-performance, reliable qPCR system is now new testing can be used to support workflows.”
In an update to the system, the multimodal software is now IVDR compliant and provides dual functionality to run diagnostic tests and develop new assays in today’s regulatory environment. The qPCR system features an intuitive touchscreen and a streamlined, efficient workflow that minimizes steps and delivers high-quality results in as little as 30 minutes. In addition, security operations are provided with security, audit and electronic signature modules.
The updated QuantStudio 5 Dx Real-Time PCR System is available in all regions where CE-IVD certification is recognized and listed by the US Food and Drug Administration (FDA).
Thermo Fisher Scientific Inc. is a world leader in serving science with annual revenue of approximately $40 billion. Our mission is to help our customers make the world healthier, cleaner and safer. Whether it’s accelerating life science research, solving complex analytical challenges, increasing laboratory productivity, improving patient health through diagnostics, or developing and manufacturing life-changing treatments, we’re here to support them. Our global team delivers an unrivaled combination of innovative technology, ease of procurement and pharmaceutical services through our industry-leading brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. Visit www.thermofisher.com for more information.
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“Thermo Fisher has been a valuable partner in supporting our development of clinical trial testing and companion diagnostics,” said Michael Sloan, Global Vice President, Commercial Operations, Almac Diagnostic Services. “Thermo Fisher’s QuantStudio qPCR System integrates seamlessly into our assay development workflow. QuantStudio 5 Dx provides the flexibility to customize solutions and provide high-quality data output for molecular diagnostic testing.”
Detect a difference as small as 1.5 times the target amount in a single reaction and achieve a linear dynamic range of 10 log units
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An interactive diagnostic tool with short run times and minimal maintenance that also uses existing plastic consumables for greater convenience in the clinical laboratory
An easy-to-use software interface allows users to set up runs, program assays, control instruments and perform plate analysis.
In vitro diagnostic (IVD) test menu allows only authorized IVD tests to be run, reducing the risk of unauthorized use and accidental or deliberate misuse
The choice is yours with software options to guide you every step of the way in diagnostic or development, test development* and IVD modes
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High reliability, precision and accuracy with an intuitive and easy-to-use interface allow users of any experience level to operate the system easily
Logs are automatically updated with maintenance and calibration events and can be printed on demand, recording systems are maintained and calibrated to supplier specifications.
Store and archive information on reagents used for each test run, including lot numbers and expiration dates. Archived files can be retrieved whenever there is a need to monitor samples tested with a particular set of reagents.
The system allows laboratories to more easily track samples associated with specific plates, reagent sets, run dates and times, and data files.
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Security, auditing, and electronic signature software records test events, actions performed, dates, usernames, user roles, and activities performed for documentation and archiving purposes.
For documentation, archiving, and at-a-glance review needs, detailed reports include experiment name, barcode, filename, timestamp (created, run started, run ended, duration and modified), instrument name, serial number, experiment type, results. It takes summary, Plate layout view, standard curve, result table and QC summary.
Control is always enabled in IVD mode and *desktop development mode. In development mode, audit mode can be set to Optional or Required based on traceability requirements.
Applied Biosystems TaqPath Real-Time PCR Master Mixes provide confidence and reliability for your most demanding molecular diagnostics development and testing needs. Application-specific formulations of TaqPath Mastermixes are available for qPCR and one-step RT-qPCR using 5-prime nuclease assay in single or multiple format. Each reagent is manufactured and labeled to Universal Reagent requirements and is functionally tested for Cq consistency and wide dynamic range to help ensure lot-to-lot reproducibility. QuantStudio 3 and 5 real-time PCR systems are designed to be fully integrated with cloud computing technology, marking a new era in data sharing and global research collaboration. (Photo: Work Wire)
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CARLSBAD, California–(BUSINESS WIRE)–A new real-time PCR system fully integrated with cloud computing technology marks a new era in data sharing and global research collaboration. Designed to support multi-institutional work with geographically diverse teams, Applied Biosystems QuantStudio 3 and QuantStudio 5 Real-Time PCR Systems will be exhibited at the 2015 American Society for Cancer Research (AACR) Annual Meeting, Pennsylvania Convention Center, booth #1501, April 18-22.
The new qPCR system is the latest addition to the Thermo Fisher Scientific QuantStudio portfolio. Designed for low to medium throughput labs performing real-time PCR experiments, QuantStudio 3 and 5 are the first to connect to the Thermo Fisher cloud computing platform, allowing applied and clinical researchers to learn, analyse, share, collaborate and get support. all on one platform. Researchers around the world can now collaborate online in real time and access their data when and where they need it. Labs can also share experimental conditions and results with their partners, while providing a unified experience for each user and helping to minimize training and errors.
“The QuantStudio 3 and 5 systems were brought to market by a team with a legacy of developing the most advanced qPCR platforms,” said Chris Linthwaite, Head of Genetic Sciences at Thermo Fisher Scientific. “For example, by connecting technology to a common computing platform, researchers trying to control outbreaks can use laboratories around the world to identify virus strains from various hotspots.
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