Method and device for monitoring a therapeutic treatment regime

A method for monitoring a therapeutic treatment regime in an individual having a disease, comprising detecting and/or measuring the concentration of a biomarker characteristic of the disease and a therapeutic compound in a biological sample obtained from the individual, the method comprising the steps of:

• (a) providing at a first location at least one solid substrate, the at least one solid substrate capable of immobilising at least the biomarker and the therapeutic compound in the biological sample, and contacting the biological sample with the at least one solid substrate to immobilise the biomarker and the therapeutic compound on and/or within the solid substrate at the first location;
• (b) transferring the solid substrate with the immobilised biomarker and therapeutic compound to a second location;
• (c) performing an extraction step on the solid substrate to extract at least the biomarker and the therapeutic compound;
• (d) performing a first detection assay to detect and/or quantify the biomarker, and performing a second detection assay to quantify the therapeutic compound;
• and
• (e) correlating the detection and/or quantity of the biomarker with the disease state of the individual, and comparing the quantity of the therapeutic compound with a target level of the therapeutic compound for treatment of the disease, to assess the efficacy of the treatment regime.

A method for determining the drug sensitivity of an individual undergoing a therapeutic treatment regime, comprising measuring the concentration of a therapeutic compound in a biological sample obtained from the individual, and determining a genotype of the individual, the method comprising the steps of:

• (a) providing at a first location at least one solid substrate, the at least one solid substrate capable of immobilising at least the therapeutic compound and endogenous nucleic acid molecules in the biological sample, and contacting the biological sample with the at least one solid substrate to immobilise the therapeutic compound and the endogenous nucleic acid on and/or within the solid substrate at the first location;
• (b) transferring the solid substrate with the immobilised therapeutic compound and endogenous nucleic acid molecules to a second location;
• (c) performing a extraction step on the solid substrate to extract at least the therapeutic compound and the endogenous nucleic acid molecules immobilised on and/or within the solid substrate;
• and
• (d) performing a first detection assay to quantify the therapeutic compound and performing a second detection assay on the endogenous nucleic acid molecules to identify a genotype of one or more endogenous gene of the individual.