ChromaDose: In-vitro diagnostic device development and validation, enabling point-of-care therapeutic drug monitoring for dose optimisation of anthracycline chemotherapy in paediatric cancer settings.

Determining anthracycline dosage in childhood cancer is a clinical dilemma due to significant drug exposure variability between children.

Despite their propensity to inflict dose-related cardiotoxicity, anthracyclines are prescribed in over half of childhood cancer cases. Current dosing regimens are suboptimal, with dose adjustments not following clear pharmacological rationale.

Standardised dosing models would reduce variable therapy intensity and subsequent side-effects, however, implementation is hampered by scarce pharmacokinetic data to validate drug exposure-response relationships.

Therapeutic drug monitoring (TDM) provides data on how individuals process drugs, guiding personalised methods of dosing based on patient pharmacokinetic characteristics.

However, current TDM involves centralised analysis, inducing pre-analytical errors via sample degradation and handling inconsistencies. Such methodology incurs decision delays, has poor scope for scalability and distance stakeholders from care pathways.

We aim to deliver ChromaDose: a point-of-care companion monitoring device; generating drug exposure data to support pharmacokinetic-led dose optimisation in paediatric oncology.

Across 30-months, a lab-proven technology will be developed into a clinic and CE-ready, anthracycline monitoring tool for second-generation TDM, offering automated quantification from blood samples, faster, cheaper and with equivalent accuracy to national laboratory benchmarks.

UCL and Vesynta Ltd shall lead device development, with Newcastle University providing reference measurement and clinical pharmacology input.

ChromaDose is supported by pan-UK Young Persons Advisory Groups, NIHR London in-vitro-diagnostic cooperative, regulatory experts, research nurses, paediatric oncologists and parents. Iterative technology development shall capture the needs of stakeholders and build a CE-ready technical file.

The final in-vitro diagnostic shall undergo validation via independent quality assessments (using spiked and banked blood samples).

Output dissemination will occur via a white-paper publication, conferences and patient-developed information media, aimed at patients, public and healthcare professionals.

ChromaDose lays the foundation for bedside pharmacokinetic-led dose personalisation, improving anthracycline safety in children, with potential to scale to multiple drug classes and patient populations in the future.