Partnering for progress: A decade of trust in Devyser CFTR

With the IVDR transition approaching, European clinical laboratories are preparing for changes that will raise the bar for compliance, documentation, and quality. At a leading university hospital in Florence, Italy, one laboratory has already built a strong foundation with Devyser CFTR, a solution they’ve relied on for years in cystic fibrosis testing. We interviewed one of their CFTR testing laboratory experts to discuss their experience with Devyser CFTR NGS. 

A natural move from capillary to NGS 

The laboratory’s CFTR testing expert has worked in the field since 2000, and their team quickly adapted as new technologies became available. 

“We started using the Devyser CFTR Core and Italia kits as soon as they were released,” the expert explains. “And once the NGS version was launched, we gradually moved away from capillary electrophoresis.” 

Today, the laboratory handles approximately 700–800 CFTR samples per year using Devyser CFTR NGS. The test is designed to sequence the whole CFTR gene in a single tube, covering all exons, exon/intron junctions, and known clinically relevant variants. With under 45 minutes of hands-on time and a total turnaround of less than five hours, it fits the demands of a high-throughput lab environment. 

Keeping it simple 

For the team in Florence, the appeal of Devyser CFTR NGS goes beyond technical performance. “The kit is super easy and fast. You can automate it, but it’s so straightforward that we don’t need to.” 

A consistent and professional collaboration with Devyser complements the simplicity of the kit. “We’ve been customers for a very long time. The collaboration is going extremely well,” the expert continues. “We know the team and trust the company.” 

Alongside its core functionality, the test includes software that aids with data interpretation, a helpful feature, especially for labs without dedicated bioinformatics support. Built-in analysis of poly-T and TG repeats also supports more complete variant detection. 

Preparing for the IVDR transition 

Devyser plans to release the IVDR-certified version of Devyser CFTR NGS. The new version will meet the EU’s updated requirements under the In Vitro Diagnostic Regulation, replacing the older CE-IVD framework and introducing tighter rules for validation and traceability. 

The laboratory is ready to make the switch. “As soon as the IVDR kit is available, we’ll inform hospital management and begin the process,” the expert explains. “There are a few administrative steps we’ll need to take, but we’re committed to using the updated version.” 

Looking ahead 

The Florence team’s experience with Devyser CFTR is built on trust, reliability, and years of practical use. “We use several kits from Devyser, not just CFTR, and we’ve always had confidence in the people behind the product,” the expert says. 

Their experience underscores the importance of validated, reliable technologies and long-term partnerships in maintaining testing quality during regulatory transitions like IVDR. 

Learn more about Devyser CFTR 

*Disclaimer: Devyser products are distributed worldwide. Not all intended uses and applications mentioned here are available in every country. Please consult your local sales representative for details.