Thermo Fisher Scientific Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System

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. 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.

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.

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.