Yourgene® Insight DPYD

 
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Yourgene DPYD genotyping assay receives IVDR certification

Yourgene® Insight DPYD - IVDR certified assay just launched!

Confidence in Every Treatment Decision

Go beyond standard DPYD testing with Insight – We are proud to launch the newest version of our DPYD genotyping kit which is IVDR certified and incorporates the latest global guideline recommendations of expanded variant coverage.

More Insight, smarter dosing, safer patients.

Read the press release here.

Introducing Yourgene® Insight DPYD

The Yourgene® Insight DPYD kit uses fluorescent ARMS (Amplification Refractory Mutation System) allele specific amplification technology, which detects point mutations, insertions or deletions in DNA, to deliver accurate, rapid detection of 19 key DPYD variants with a fast turnaround time of only 4 hours! For a full list variants see the table below.

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Key Benefits of Yourgene® Insight DPYD

Yourgene Health | the IONA® test | 99% detection rate
  • Comprehensive variant detection providing enhanced global coverage
Yourgene Health | the IONA® test | 99% detection rate
  • Highly multiplexed two-tube assay with ready to use reagents - just add DNA
Yourgene Health | the IONA® test | 99% detection rate
  • Fast results with a 4-hour turnaround time
Yourgene Health | the IONA® test | 99% detection rate
  • IVDR certified assay, delivering high-quality, reliable results

Yourgene® Insight DPYD Workflow

  • Simple, streamlined workflow
  • High throughput flexibility
  • Cost and time-efficient
  • Easy data analysis
  • Secure, local data interpretation
  • No specialised equipment required
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Yourgene® Insight DPYD kit technical details

Parameter
Details
Format
Two-tube assay:
- Tube 1 detects the 19 defined variants
- Tube 2 detects the corresponding wildtype sequence to detect heterozygotes
- STR markers are included in each tube to aid sample identification
PCR method
ARMS-PCR
Hands on time
<60 mins
Total turnaround time
PCR: ~3 hoursCapillary Electrophoresis: ~1 hour
Intended sample type
DNA extracted from whole human blood (EDTA preserved)
Instrumentation
Thermal Cycler & Capillary Electrophoresis Genetic Analysers. Developed on ABI 3500 and SeqStudio CE instruments
Software analysis
GeneMapper™ or GeneMarker®

Seraseq® DPYD DNA Mutation Mix

You can now buy reference material from us when purchasing Yourgene® Insight DPYD kits.

We stock the Seraseq® DPYD DNA Mutation Mix (RUO), which is compatible with the Yourgene® Insight DPYD Assay (RUO). 

 

Please note, the Seraseq® DPYD DNA Mutation Mix is sold separately to the Yourgene® Insight DPYD assay. If you wish to order the reference materials, please ask your local sales rep or distributor.
Please note, it is the customer's responsibility to fully validate the Seraseq® DPYD DNA Mutation Mix before use.  

Accuracy

Accuracy was determined to be 99.43% positive percent agreement (PPA), 99.99% negative percent agreement (NPA), and 99.97% overall agreement (OA) compared to Sanger sequencing Accuracy of the Yourgene® Insight DPYD assay was assessed by evaluating 148 samples representing a wide variety of gene variants from six separate sources.

Repeatability

Repeatability results showed 100% PPA, 100% NPA, and 100% OA. This data provides evidence that the Yourgene® Insight DPYD assay produces consistently repeatable results.

Reproducibility

Reproducibility results showed 100% PPA, 100% NPA, and 100% OA. This data provides evidence that the Yourgene® Insight DPYD assay produces consistently reproducible results. 

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Implementing DPYD Genotyping into Clinical
Practice

In this edition of Your Expert, Yourgene Health interviewed Dr. Daniel Hertz, Associate Professor at the University of Michigan College of Pharmacy, about the importance of DPYD testing, it’s role as a standard of care, and the ongoing challenges to broader clinical adoption.

Download Paper
YEX016 A Quality & Regulatory perspective on IVDR

Introducing Yourgene® Insight DPYD!

Variant Related Publications

Del Re, M., Cinieri, S., Michelucci, A., Salvadori, S., Loupakis, F., Schirripa, M., Cremolini, C., Crucitta, S., Barbara, C., Di Leo, A. and Latiano, T.P., 2019. DPYD* 6 plays an important role in fluoropyrimidine toxicity in addition to DPYD* 2A and c. 2846A> T: a comprehensive analysis in 1254 patients. The pharmacogenomics journal, 19(6), pp.556-563.

Available at: https://doi.org/10.1038/s41397-019-0077-1 (Accessed: 1 June 2026).

Iachetta, F., Bonelli, C., Romagnani, A., Zamponi, R., Tofani, L., Farnetti, E., Nicoli, D., Damato, A., Banzi, M., Casali, B. and Pinto, C., 2019. The clinical relevance of multiple DPYD polymorphisms on patients candidate for fluoropyrimidine based-chemotherapy. An Italian case-control study. British journal of cancer, 120(8), pp.834-839.

Available at https://doi.org/10.1038/s41416-019-0423-8 (Accessed: 1 June 2026).

Božina, N., Bilić, I., Ganoci, L., Šimičević, L., Pleština, S., Lešnjaković, L. and Trkulja, V., 2022. DPYD polymorphisms c. 496A> G, c. 2194G> A and c. 85T> C and risk of severe adverse drug reactions in patients treated with fluoropyrimidine‐based protocols. British journal of clinical pharmacology, 88(5), pp.2190-2202.

Available at https://doi.org/10.1111/bcp.15144 (Accessed: 1 June 2026).

Ardizzone, A., Bulzomì, M., De Luca, F., Silvestris, N., Esposito, E. and Capra, A.P., 2024. Dihydropyrimidine dehydrogenase polymorphism c. 2194G> A screening is a useful tool for decreasing gastrointestinal and hematological adverse drug reaction risk in fluoropyrimidine-treated patients. Current Issues in Molecular Biology, 46(9), pp.9831-9843.

Available at https://doi.org/10.3390/cimb46090584 (Accessed: 1 June 2026).

Coenen, M.J., Paulussen, A.D., Breuer, M., Lindhout, M., Tserpelis, D.C., Steyls, A., Bierau, J. and van den Bosch, B.J., 2019. Evolution of dihydropyrimidine dehydrogenase diagnostic testing in a single center during an 8-year period of time. Current Therapeutic Research, 90, pp.1-7.

Available at https://doi.org/10.1016/j.curtheres.2018.10.001 (Accessed: 1 June 2026).

de Haar-Holleman, A., Cortoos, P.J., Vlaeminck, J., Van Landuyt, P., Steurbaut, S., Vaeyens, F. and Haufroid, V., 2024. Case report: A case of severe capecitabine toxicity due to confirmed in trans compound heterozygosity of a common and rare DPYD variant. Frontiers in pharmacology, 15, p.1459565.

Available at https://doi.org/10.3389/fphar.2024.1459565 (Accessed: 1 June 2026).

Larrue, R., Fellah, S., Hennart, B., Sabaouni, N., Boukrout, N., Van der Hauwaert, C., Delage, C., Cheok, M., Perrais, M., Cauffiez, C. and Allorge, D., 2024. Integrating rare genetic variants into DPYD pharmacogenetic testing may help preventing fluoropyrimidine-induced toxicity. The Pharmacogenomics Journal, 24(1), p.1.

Available at https://doi.org/10.1038/s41397-023-00322-x (Accessed: 1 June 2026).

Pepe, N., Maddaloni, V. and Perfetti, A., 2022. Personalized therapy: the crucial role of the DPYD c. 2194G> A (V732I) allele in the treatment of colorectal cancer patients candidates for therapy with fluoropyrimidines. J Stem Cell Res Ther, 7(1), pp.18-20.

Available at https://DOI: 10.15406/jsrt.2022.07.0015 (Accessed: 1 June 2026).

Gaedigk, A., Turner, A.J., Moyer, A.M., Zubiaur, P., Boone, E.C., Wang, W.Y., Broeckel, U. and Kalman, L.V., 2024. Characterization of reference materials for DPYD: a GeT-RM collaborative project. The Journal of Molecular Diagnostics, 26(10), pp.864-875.

Available at https://doi:10.1016/j.jmoldx.2024.06.004 (Accessed: 1 June 2026).

Cui, E., Medwid, S., Schwarz, U.I. and Kim, R.B., 2025. Potential clinical relevance of rare dihydropyrimidine dehydrogenase genetic variants identified using whole-exome NextGen sequencing in cancer patients with severe fluoropyrimidine toxicity. Cancer Chemotherapy and Pharmacology, 95(1), p.121.

Available at https://doi.org/10.1007/s00280-025-04839-9 (Accessed: 1 June 2026).

Related Publications

Amstutz, U. et al. (2018) ‘Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines update for DPYD and fluoropyrimidine dosing’, Clinical Pharmacology & Therapeutics, 103(2), pp. 210–216.

Available at: https://doi.org/10.1002/cpt.911 (Accessed: 14 May 2026).

Lunenburg, C.A.T.C. et al. (2020) ‘Prospective DPYD genotyping to reduce the risk of fluoropyrimidine-induced severe toxicity: Ready for prime time’, European Journal of Cancer, 124, pp. 47–56.

Available at: http://dx.doi.org/10.1016/j.ejca.2015.11.008 (Accessed: 14 May 2026).

DPYD Genotyping Recommendations (2024) The Journal of Molecular Diagnostics.

Available at: https://www.sciencedirect.com/science/article/pii/S1525157824001545 (Accessed: 14 May 2026).

Clinical Pharmacogenetics Implementation Consortium (CPIC) (no date) CPIC Guideline for DPYD and Fluoropyrimidines.

Available at: https://www.clinpgx.org/guideline/PA166251462 (Accessed: 14 May 2026).

Clinical Pharmacogenetics Implementation Consortium (CPIC). DPYD Reference Materials.

Available at: https://www.clinpgx.org/page/dpydRefMaterials (Accessed: 14 May 2026).

American Society of Clinical Oncology (ASCO) (2023) ‘Testing for DPYD variants to reduce fluoropyrimidine toxicity’, Journal of Clinical Oncology.

Available at: https://ascopubs.org/doi/10.1200/JCO.22.02364 (Accessed: 14 May 2026).

Association for Molecular Pathology (AMP) (2024) AMP statement on DPYD testing.

Available at: https://www.amp.org/AMP/assets/File/pressreleases/2024/AMP_DPYD_FINAL.pdf?pass=89 (Accessed: 14 May 2026).

Ending the controversy around pretreatment dihydropyrimidine dehydrogenase (DPD/DPYD) testing heightens the controversy over appropriate fluoropyrimidine dosing (2023) Journal of Clinical Oncology.

Available at: https://ascopubs.org (Accessed: 14 May 2026).

U.S. Food and Drug Administration (FDA) (no date) Drugs@FDA: FDA-approved drugs.

Available at: https://www.accessdata.fda.gov/scripts/cder/daf/ (Accessed: 14 May 2026).

European Medicines Agency (EMA) (2020) Xeloda / Capecitabine Accord / Capecitabine Medac / Capecitabine Teva / Ecansya (previously Capecitabine Krka) / Teysuno - direct healthcare professional communication (DHPC).

Available at: https://www.ema.europa.eu (Accessed: 14 May 2026).

U.S. Food and Drug Administration (FDA) (2024) Safety labeling update for capecitabine and fluorouracil (5-FU): Risks associated with dihydropyrimidine dehydrogenase deficiency.

Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/safety-labeling-update-capecitabine-and-fluorouracil-5-fu-risks-associated-dihydropyrimidine (Accessed: 14 May 2026).

U.S. Food and Drug Administration (FDA) (2024) FDA approves safety labeling changes regarding DPD deficiency for fluorouracil injection products.

Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-safety-labeling-changes-regarding-dpd-deficiency-fluorouracil-injection-products (Accessed: 14 May 2026).

Clinical Pharmacogenetics Implementation Consortium (CPIC). CPIC guideline for DPYD and fluoropyrimidines.

Available at: https://www.clinpgx.org (Accessed: 14 May 2026).

Canadian Drug Agency (CDA-AMC) (2025) DPYD Testing.

Available at: https://www.cda-amc.ca/sites/default/files/pdf/htis/2025/RC1575-DPYD_Testing.pdf (Accessed: 14 May 2026).

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