Today, the main gap in the market of point-of-care (POC) devices lies in the detection of disease markers other than simple blood chemistry and electrolytes and glucose. Immunoassays are more complicated. Those molecules are currently identified using laboratory-based ELISA (enzyme-linked immunosorbent assay). Another benefit of current ELISA tests is that they offer both qualitative and quantitative results.
Many attempts have been made to “transfer” ELISA to POC, mostly utilizing expensive optics or microfluidics-based technologies. Immunoassays are also more challenging because they require proteins to interact and bind to each other and they require a wash cycle. The washing step is the main reason why most of today’s approaches use some kind of microfluidic mechanism - that in turn increases the cost and reduces the robustness of the tests.
To the best of our knowledge, our technology is the only one that enables truly affordable measurement of biomarker levels at home. Namely, most other competing approaches rely on detection and quantification of biomarkers using optics, spectroscopy, fluorescence, chemiluminescence or visualization of test band using a camera. While the underlying technologies are often very sensitive and reliable, their main barrier is the high cost of the readers that are typically over $1000. Moreover, they are often bulky and not suitable for home use.
We have created our technology with the end user in mind. We wanted to develop something that is both easy to use, affordable and at the same time of laboratory-grade quality and precision.
Point-of-care diagnostics and diagnostics markets are widely recognized as markets with a high barrier of entry due to the concentration of the markets and dominance by big multinational diagnostic companies such as Roche, Abbott, Alere, BD Diagnostics, BioMérieux and others. Development of novel diagnostics is associated with high research and development costs that compound the barriers of entry.
However, the existing diagnostic market is shifting towards the idea of recentering diagnostics on people, rather than using the widespread centralized diagnostic laboratory model. As reported in Nature Biotechnology: “Investors are pumping money into start-ups chasing the holy grail of finger-prick diagnostics, and big players keep on acquiring innovators in the space." (Nature Biotech)
Here lies the key to lowering the perceived high-barrier of entry by employing the business strategy of bringing a product to a stage where the ‘big players’ are incentivized to take-over, acquire or license the technology.