The LIBERATE Feasibility Study sought to identify the market opportunity and technological requirements for a rapid near-patient blood testing device for general diagnosis and health surveillance of a large and aging population. The instrument will be approximately the size of a credit card reader and perform 10-20 tests from 10 micolitres of blood in 10 minutes. The blood tests will be supported on a chip as a card into the instrument; single use for each patient. We consulted with UK primary care physicians (GPs) as to which tests would be most useful firstly as a general triage and surveillance of public health; a General Diagnosis Array (GDA). The GPs supported the concept of public health surveillance and identified a set of tests that would be most appropriate. From these responses and other consultations, the GDA would be used on 6% of all consultations, an indicative market size of €1.3bn annually in the UK. We also assessed the market for three other chips, a Blood Profile Array, a Liver Function and Kidney Function Array and a Metabolic Profile Array. These chips have markets size estimates of: €0.9bn €0.5bn and €0.5nbn respectively. The GDA market in the EU (scaling for population) would be €10.2bn.
The GP consultation established the value chain for the GDA identifying the current costs. Our estimates for the UK suggest this process costs €184 - €244 including all of the time to organise the logistics. The GDA will free up 20M GP second appointments annually, saving the NHS €2.1bn in addition to providing the patient with the tests results and care pathway at the first meeting.
Our initial set of tests confirmed by the GPs was: CRP, White Blood Cells, D-Dimer, Troponin I/T, C3 and C4. The results for CRP were completely successful with a CV of 5.2% compared with standard laboratory measurements. Development is on going for C3 (CV 18%) and C4, Troponin T/I, D-dimer where the results were qualitative.
The feasibility study has clearly demonstrated a market for a new vision of patient care - “Test and Treat the Patient” - which includes significant benefits to both to patient outcome and health economic advantages and the additional new idea of using the patient as their baseline. If normal-for-the-patient levels are known then small changes can be detected enabling a care pathway tailored for each patient to be managed, no matter where they are geographically. Our array technology will truly LIBERATE public healthcare.
