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Real-Time PCR System Advances Large Reaction Volume IVD Assay Development and Diagnostic Testing

By LabMedica International staff writers
Posted on 02 Feb 2023
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Image: CFX Opus Deepwell Dx Real-Time PCR System (Photo courtesy of Bio-Rad)
Image: CFX Opus Deepwell Dx Real-Time PCR System (Photo courtesy of Bio-Rad)

Amidst the ongoing increase in demand for efficient and flexible IVD real-time PCR systems, a new real-time PCR system advances large reaction volume IVD assay development and diagnostic testing.

Bio-Rad Laboratories (Hercules, CA, USA) has launched the CFX Opus Deepwell Dx Real-Time PCR System that offers accurate and precise quantification with flexibility for reactions up to 125 µl in a 96-well format for quantitative PCR (qPCR) diagnostic assays. This latest addition to the Bio-Rad portfolio of real-time PCR instruments is also available in a 96- and 384-well reaction block format. All systems in the CFX Opus Dx Real-Time PCR family are open platforms that can multiplex up to five targets to enable efficient IVD assay development and diagnostic testing. CFX Opus Dx Real-Time PCR Systems offer easy-to-use desktop management and analysis software with integrated security features for electronic signature, audit, and user control.

The CFX Opus Deepwell Dx Real-Time PCR System is listed with the U.S. Food and Drug Administration (FDA) for in vitro diagnostic (IVD) testing, and has been developed in accordance with the European Union’s regulations for in vitro diagnostic medical devices (EU 2017/746). Bio-Rad will continue to seek regulatory approvals for additional global markets in the coming months.

"With the ongoing increase in demand for efficient and flexible IVD real-time PCR systems, we are pleased to announce the addition of the CFX Opus Deepwell Dx Real-Time PCR System to the CFX Opus family," said Steven Blakely, Senior Director for the Gene Expression Business, Bio-Rad. "The CFX Opus Deepwell Dx Real-Time PCR System continues in the tradition of robust and secure platforms that leverage the long-standing Bio-Rad expertise in genomic tools to serve both research and clinical diagnostic markets."

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