Delivery of healthcare is changing; the demand for rapid diagnostic testing is becoming more prevalent. The new global imperative is to speed up the diagnostic process, tailoring it more effectively to individual patients and their circumstances.
Testing at an earlier stage in the disease cycle for chronically sick patients offers clear potential to improve their quality of life by allowing self monitoring of their conditions at home or locally, rather than requiring hospital visits. In acute situations, where speed of diagnosis is critical, effective PoC testing has a crucial role to play. For example, the possibility of running an accurate and precise Troponin I assay in an ambulance on a potential heart attack patient may make a material difference to treatment and clinical outcome.
The factors driving this new approach create an opportunity for rapid diagnostic testing to play a more significant role in the patient care cycle. There is clear demand for rapid, intuitive, easy to use, robust handheld technologies that can safely take the testing environment to patients at a practical cost. Such platforms must deliver the level of sensitivity required for accurate measurements, from the smallest possible sample, and with the precision and accuracy of hospital laboratory systems.
The PoC market is growing rapidly. Forecasters suggest 10% growth per annum over the next 4-5 years making the total market worth over $22 billion. Growth rates are driven by the wider adoption of PoC technologies and new product launches. Improved accuracy and tests for a wider number of conditions will continue to see the self-test market develop rapidly. A key opportunity is for improved PoC product penetration in primary and secondary care settings.
Effective and reliable PoC technologies at the right price, such as those developed and in development by Bio-AMD can meet this need; improving care, saving costs and positively affecting clinical outcomes.
Bio-AMD has positioned itself as a leading innovator in the field of reader technology development
PoC diagnosis requires the combination of two main fields of science:
1. Bio-chemistry designed to detect changes in body fluid chemistry and signal a medical condition and;
2. Electro-mechanical engineering required to create apparatus to measure those chemical changes.
There are three elements to the successful delivery of PoC diagnosis:
1. The biochemistry itself; and
2. The medium that holds and combines the bio-chemistry with a body fluid sample; and
3. The device (reader) that detects the changes in the biochemistry and communicates the result to the user/patient.
The most typical format for the detection medium is a ‘smart’ strip e.g. a lateral flow strip that allows diagnostics chemistry and extracted body fluid to mix and react in a pre-determined way. Readers are typically designed to read the chemical changes on detection strips. Against this background the main trends in the PoC market are:
the development of increasingly wide ranges of complex bio-chemical detectors and markers;
the increasing sophistication of smart strips to accommodate the innovations in bio-chemistry and;
the increasing sophistication of readers, now regarded as alternatives and complements to complex laboratory equipment.
The first stage of our corporate strategy has been to develop a universal digital strip reader (DSR) capable of reading a variety of lateral flow strips to detect differing conditions. We also have in an advanced stage development a blood coagulation monitor (COAG) and a quantitative Magnetic Immunoassay detection System (MIDS).