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Devyser CFTR

Full CFTR gene sequencing with unmatched simplicity

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What is Devyser CFTR? 

Devyser CFTR is a CE-marked (IVDR) NGS solution for full-gene CFTR analysis that detects SNVs and indels, CNVs, and the poly‑T/TG repeat in one run. The streamlined protocol provides unmatched simplicity, minimizing handling and supporting standardized routine diagnostics. The assay has been designed to keep pace with evolving clinical guideline recommendations, for example the updated ACMG variant list and the ever-expanding CFTR2 database.1,2

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“We have tried many assays of various types, but targeted, amplicon-based sequencing with high quality and high coverage is the best method for a clearly defined disease like cystic fibrosis.”

Prof. Milan Macek (M.D., DSc.), President of the Czech Society of Medical Genetics and Genomics 

Devyser CFTR – Product features

Equip your lab with IVDR-certified CFTR gene sequencing in a single tube: efficient, reliable, and accurate. 

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Broad-coverage
software

Streamlined workflow 

Pre-dispensed indexes and a single pooled clean‑up minimize handling and lower mix‑up risk; typical hands-on time is under 45 minutes. 

Broad coverage  

Targets include exons, exon–intron junctions, promoter, and selected deep‑intronic regions, reducing the need for downstream assays and supporting cost‑effective testing. 

Integrated analysis software 

Amplicon Suite CFTR converts FASTQ into consolidated results for SNVs/indels, CNVs, and poly‑T/TG, minimizing reliance on in‑house bioinformatics. The software supports filtered results for both screening and full gene analysis. 

Ethical and equitable CFTR testing 

Fixed mutation panels can show ancestry‑related bias, lowering sensitivity in many non‑European groups. Full‑gene sequencing mitigates missed or delayed diagnoses in underrepresented populations. 

Population genetics and equity 

Sequencing beyond legacy mutation panels aligns testing with today’s changing demographics and supports equitable carrier screening and diagnostics. 

Clinical utility over panel bias 

Broader CFTR genotyping captures both common and rare or population‑specific variants, improving clinical decision‑making. 

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Why choose Devyser CFTR? 

  • Single-tube target amplification limits mix-ups and contamination. 
  • Pre-dispensed indexing reduces handling and errors. 
  • Pooled library clean‑up in one tube saves time. 
  • Unique dual detection of exon-spanning deletions eliminates the need for confirmatory testing. 

 

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Scalable solution 

Suitable for both small laboratories and high‑throughput centers. From 8 to 192 samples per experiment, run urgent small batches to keep turn around time (TAT) short or fill plates for maximum efficiency with predictable cost per sample. 


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CFTR_Workflow

 

Simplest workflow

Single-tube target amplification to limit mix-ups and contamination, pre-dispensed indexing to reduce handling and errors, and pooled library clean-up in one tube to save time.


Ready to bring clarity, efficiency, and confidence to your workflow? 

Contact us to learn more about Devyser CFTR.

Downloads

Instructions for use

Enter access code found in the lower right corner of the label on the kit box.

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Certificates

Download a specific Batch Release Certificate (BRC) below.

Guidelines and handbooks (1)

Handbook Devyser CFTR 7-A130 BA 03 (English)

pdf

Download

Product information (2)

Flyer Devyser CFTR RUO 2023-12-14 (English)

89 kb pdf

Download

Flyer Devyser CFTR IVDR 25-10-28 (English)

614 kb pdf

Download

Software settings (13)

MiSeq IEM Files (English)

zip

Download

Illumina double index (English)

zip

Download

CFTR2 Mutation List 268 2017-03-17 (English)

pdf

Download

SeqNext Guide Devyser CFTR 2019-12-05 (English)

pdf

Download

CFTR2 Mutation List For 1st Level Screening 2017-03-17 (English)

pdf

Download

Devyser CFTR Full SN4.3 Hg19 2019-11-19 (English)

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Devyser CFTR Full SN4.3 Hg38 2019-11-19 (English)

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Devyser CFTR screening_SN4.3_hg19_2019-05-21 (English)

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Devyser CFTR screening_SN4.3_hg38_2019-05-21 (English)

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Download

Devyser-CFTR_Hg19_2019-04-11 (English)

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Devyser-CFTR_Hg38_2019-05-20 (English)

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Download

Devyser-CFTR_DirectDetections_2019-04-11 (English)

Download

Devyser CFTR LRM files v2023-11-01 (English)

zip

Download

Safety data sheets (1)

SDS Devyser NGS products 7-A428 (English)

486 kb pdf

Download

Data tables (0)

Enter access code found in the lower right corner of the label on the kit box.

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Product details

CE-IVDR

Devyser CFTR NGS

Single‑tube full CFTR gene sequencing with comprehensive variant detection.

8-R101-24

8-R101-96

Pack size: 24

Pack size: 96

CE-IVD

Devyser CFTR NGS

Single‑tube full CFTR gene sequencing with comprehensive variant detection.

8-A101-8

8-A101-24

8-A101-96

Pack size: 8

Pack size: 24

Pack size: 96

RUO

Devyser CFTR NGS

Single‑tube full CFTR gene sequencing with comprehensive variant detection.

8-A103-8

8-A103-24

8-A103-96

Pack size: 8

Pack size: 24

Pack size: 96

Frequently asked questions (FAQs) about Devyser CFTR

How is Devyser CFTR different from other CFTR assays?

It is a single‑tube, amplicon‑based NGS assay with pre‑dispensed indexing and one pooled clean‑up to minimize handling, mix‑ups, and contamination. The CE‑marked (IVDR) workflow includes integrated analysis (Amplicon Suite CFTR) that reports SNVs, indels, CNVs, and poly‑T/TG from one run. A unique dual detection approach allows for robust detection of exon-spanning deletions.  

How are results analyzed, and which variants are reported?

Amplicon Suite CFTR converts FASTQ files into consolidated calls for SNVs/indels, CNVs, and poly‑T/TG, reducing reliance on in‑house bioinformatics. 

What sample types are accepted?

Extracted genomic DNA (refer to the IFU for full details and requirements). 

How does Devyser CFTR integrate with our workflow?

Compatible with Illumina platforms; typical hands‑on time is under 45 minutes. Scales from urgent small batches to high throughput with 8 to 192 samples per index plate and predictable cost per sample. 

Is the assay suitable for carrier screening programs?

Yes. Sequencing mitigates ancestry‑related bias inherent to fixed mutation panels and supports equitable testing in reproductive carrier screening. 

Does Devyser CFTR include guideline‑recommended variants?

The assay is designed to align with evolving recommendations (e.g., ACMG) and developed with the CFTR2 database in mind. It detects common, rare, or population‑specific variants. For site‑specific requirements, consult the IFU and release notes. 


Does Devyser offer technical and scientific support?

Yes. Support is available for assay setup and validation as well as data analysis and troubleshooting. 

Devyser CFTR in literature

These peer‑reviewed studies and conference posters demonstrate how Devyser CFTR is applied in real‑world diagnostics and research-spanning variant detection, newborn screening, and population genetics across multiple countries. 

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.
References:
  1. Deignan JL, Gregg AR, Grody WW, et al.; ACMG Board of Directors. Updated recommendations for CFTR carrier screening: a position statement of the American College of Medical Genetics and Genomics (ACMG). Genet Med. 2023;25(8):100867. doi:10.1016/j.gim.2023.100867
  2. CFTR2. CFTR2: Clinical and Functional Translation of CFTR. Updated September 25, 2024. Accessed October 22, 2025. https://cftr2.org