European Union grants CE IVD Marking for flagship Bio-Rad in vitro diagnostic system

In the race to develop rapid, highly sensitive cancer diagnostics that can detect the disease when it is little more than a suspicion of rogue cells in the blood stream, liquid biopsies have begun to emerge as the industry favourite to deliver those tools to the clinic. This week Californian biotech firm Bio-Rad announced that their QX200 Droplet Digital PCR System has become the first of its kind to bag a CE kite mark from the EU for use as an in vitro diagnostic tool. 

Since 2011 the Bio-Rad system has only been available to researchers, but with the CE IVD Mark the company can now begin to market their device to medical practitioners in Europe. We sat down with Carolyn Reifsnyder from Bio-Rad’s Digital Biology Center, to find out more.  

FLG: Firstly, this is really great news! Having the CE IVD marking for the QX200 System is obviously an exciting step, enabling Bio-Rad to move your product from the lab to the clinic in Europe. How does the Droplet Digital PCR approach work, and how do you hope it will integrate into current clinical practice?

CR: The digital PCR principle involves partitioning a DNA (or RNA) sample into thousands of nanoliter-sized droplets, each containing randomly distributed copies of target DNA. Each droplet behaves as an individual PCR reaction using primers and fluorescent probes specific to the target sequence. After amplification, droplets containing the now amplified target sequence are detected as fluorescent and scored as positive, while droplets lacking fluorescence are scored as negative, providing a precise and direct quantification of target DNA within the sample. We see many Bio-Rad QX100 and QX200 droplet digital PCR Systems being used in clinical research already, and several customers pushing into clinical trials.

QX200 Bio-Rad

Bio-Rad’s QX200 Digital Droplet PCR system

FLG: Liquid biopsy has enormous potential for the early detection of cancer, and your system is currently involved in series of trials with the Dana-Farber Cancer Institute. Can you give us an overview of what is involved in those studies, and the outcomes that you are hoping for?

CR: The group at Dana-Farber Cancer Institute has been doing incredible work like the ground-breaking study (Clin Cancer Res, 2014) in lung cancer and melanoma demonstrating the effective monitoring of disease status and response to therapy in plasma cell free DNA. Droplet Digital PCR technology was able to anticipate a change in the patient as much as 4 months before conventional CT scans. The paper emphasized the importance of greatly improved turnaround time, cost, and sensitivity of liquid biopsy over tissue biopsy. Liquid biopsy also provides a solution to the not uncommon absence of tissue for biospsy. Just this past year, researchers from DFCI presented a poster at ASCO, attached below for your reference, outlining their work.

The clinicaltrials.gov website describes their NSCLC trial and includes newly diagnosed melanoma patients. In January of this year, the study was updated and enrollment has increased from 300 to 540, and they’ve added a fourth category of included patients.

We understand their future work will include Droplet Digital PCR screening ahead of, but in parallel to NGS, to inform rapid treatment choices.

FLG: Annette Tumolo, Executive Vice President for Bio-Rad’s Digital Biology Group described the CE IVD approval as “the first step” in bringing this technology to the clinic. What comes next, and what do you see as the major challenges in getting QX200 into clinics worldwide? Is there anything else that you would like to share with our readers?

CR: In the second half of this year, Bio-Rad will offer the QX200 AutoDGTM ddPCR System with CE IVD marking, as well as CE IVD-marked consumables and reagent kits for both systems. Bio-Rad is also currently seeking IVD clearance from the U.S. Food and Drug Administration (FDA).

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