As assay developers and clinical testing laboratories consider next steps for molecular diagnostics after the pandemic, Thermo Fisher Scientific has introduced a new in vitro diagnostic or IVD system intended to help developers and laboratories expand their assay menus and IVD testing capabilities. 

According to the company, the Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System is a compact instrument designed to transition easily 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,” says Santhosh Nair, vice president and general manager of qPCR at Thermo Fisher Scientific. “We are continuing to expand our IVD portfolio to support our customers in this space. 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. For molecular laboratories developing and running their own tests, embedded regulatory controls support traceability to reduce the 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.

For more information, please visit Thermo Fisher Scientific.

Featured Image: The Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System, a new IVD system from Thermo Fisher Scientific, is designed to help assay developers and clinical testing laboratories expand their assay menus and IVD testing capabilities. Photo: Thermo Fisher Scientific