As assay developers and clinical testing laboratories consider next steps for molecular diagnostics post-pandemic, a new in vitro diagnostic (IVD) system from Thermo Fisher Scientific will enable them to expand their assay menus and IVD testing capabilities moving forward.

The Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System is a compact instrument that easily transitions from development to validation for maximum productivity. The system’s software comes with preconfigured run, analysis and report settings to reduce the risk of manual errors and improve efficiency. Designed for fast ramp-up and use by laboratory technicians with no specialized training, the system also includes remote desktop and touchscreen controls, facial authentication, voice command, and smart tech support to improve productivity.
“qPCR is an essential tool for clinical testing laboratories, and we have seen its importance for monitoring and managing the pandemic. We are continuing to expand our IVD portfolio to support our customers in this space,” said Santhosh Nair, vice president and general manager of qPCR at Thermo Fisher Scientific. “The QuantStudio 7 Pro Dx Real-Time PCR System can be used to develop new assays and then validate and run high-volume clinical diagnostic tests.”

Users can expand their assay menus with interchangeable 96-well and 384-well blocks and automation compatibility. In addition, for molecular laboratories developing and running their own tests, embedded regulatory controls support traceability to reduce risk of unauthorized use or potential misuse.

The U.S. Food and Drug Administration (FDA) has listed the QuantStudio 7 Pro Dx Real-Time PCR System as a class II medical device.

Source: Company Press Release