Therapeutic Drug Monitoring with Smartphone-integrated Surface Enhanced Raman Spectroscopy

ended

Therapeutic drug monitoring (TDM) is an essential tool for measuring the circulating concentration of specific narrow therapeutic drugs at designated intervals, in order to maximise the efficacy of the drug and avoid toxicity and adverse drug reactions. TDM is currently available only in central laboratories or large hospitals, and several barriers prevent its wide implementation in routine clinical practice. First, current technologies used for TDM (e.g. high-performance liquid chromatography – HPLC, mass spectrometry – MS) are exclusively used in central laboratories due to their cost, system size and weight, complexity of use and maintenance requirements. Second, alternative technologies (e.g. ELISA immunoassays) are analyte-specific and do not allow adaptability to new analytes (increasing costs). We verified the feasibility and clinical utility of using Surface Enhanced Raman Spectroscopy (SERS) for TDM using real plasma samples taken from de-identified patients. Importantly, our measurements were consistent with state-of-the-art data generated by LC-MS/MS. We already have experimentally shown a 0.1 μM detection limit on pure, artificial samples. Within THERA, we aim to transform our research output into a commercially-relevant (in terms of size, throughput, user friendliness and cost) product by creating a minimum viable product that will enable TDM for a wide variety of molecules. Our goal within this project is to validate this device on clinical samples and build a strong business case for it that will enable commercial exploitation. THERA will advance our SERS-based device from a current technology readiness level of 3 to 5/6. Our value proposition is a tabletop, miniaturized (smartphone-sized) device that can perform TDM on a single droplet of blood, in a matter of minutes, without the need for specialized personnel, at a fraction of the cost currently associated with TDM.