EMQN is pleased to announce that it has been awarded funding through the CADDA Knowledge Transfer Vouchers scheme for the project “Engineered CYP2C19 Cell Lines for Point‑of‑Care Test (POCT) Quality Assessment”, delivered in collaboration with The University of Manchester.
This project will apply CRISPR‑Cas9 genome editing to develop high‑quality, well‑characterised reference materials containing clinically important variants of the CYP2C19 gene. These materials will address a recognised gap in the development and validation of pharmacogenomic point‑of‑care tests, where access to rare but critical genetic variants is currently limited.
Reliable and Regulated Pharmacogenomic POCT
Pharmacogenomic POCT enables clinicians to make rapid, gene‑informed treatment decisions, particularly in acute clinical settings. However, the evaluation and regulatory approval of these tests depends on the availability of robust reference materials to assess test accuracy, reliability, and performance.
Through this CADDA‑funded collaboration, engineered cell lines will be created to represent key CYP2C19 variants affecting drug metabolism. These variants will be combined to mimic real patient genotypes and incorporated into patient‑like artificial samples, such as buccal swabs, suitable for POCT quality assessment.
The resulting materials will support:
- Quality assessment and validation of pharmacogenomic POCT
- Regulatory approval processes
- Greater confidence in test performance in clinical practice
By strengthening the quality framework around POCT, the project aligns closely with EMQN’s mission to improve the accuracy, reliability, and clinical impact of genomic testing worldwide.
Building Foundations for Future Expansion
In addition to addressing current needs in CYP2C19 testing, the project will expand an existing variant library to include additional clinically relevant variants. This work will also lay the groundwork for extending the approach to other genes and future point‑of‑care diagnostic applications, supporting broader adoption of personalised medicine