miRNA (microRNA) is a recently discovered type of biomolecules implicated in numerous biological systems and in common human diseases (e.g. cancer, aging and degenerative diseases, etc.). In the past decade, the research on miRNAs has soared with over 60,000 papers deposited on PubMed related to the use of miRNA. To give an example of the value of miRNA analysis, it has recently been shown that classification of tumour subtypes by miRNA is more accurate than the gold standard classification by protein . The following is a small list outlining the value and importance of miRNA analysis in medicine:
• Used or believed to act as a biomarker to detect and quantify the progression of many diseases including but not limited to Cancer, Heart Diseases, Kidney Diseases, Nervous system, etc.
• Serve as early biomarkers for the evaluation of drug efficacy and drug safety
• Aid in the establishment of anti-viral drugs and/or vaccines for a number of viruses such as the herpesvirus.
While the value of miRNA analysis is clear, miRNA is extremely difficult to analyse. To date, the three major profiling methods are qPCR (RT-PCR), Microarray and NextGen Sequencing (NGS), however each method suffers from limitations thereby limiting its use to research only. The following list outlines the customer pain and therefore the key requirements in miRNA analysis:
• Analysis directly on the sample – The current solutions are unable to work directly on the sample, which, in medicine, are mostly plasma, serum and cells. So before performing assays current solutions require an extra process to extract/purify and prepare miRNA. This procedure is complicated by the ubiquitous presence of ribonuclease enzymes in cells and tissues, which can rapidly degrade microRNA. Extraction/Purification is also needed because current solutions are easily influenced by sample contaminants (i.e. proteins, salts).
• Throughput – Current solution require too much time for a single analysis, thereby limiting their throughput: qPCR – 6 hours for a single analysis including 3 hours of hands-on work by an expert; Microarray - 2 days for a single analysis including 6 hours of hands-on work by an expert; NGS - 2 days to 2 weeks for a single analysis including 6 hours of hands-on work by an expert.
• Specificity – relates to the ability for an analysis to provide accurate results over a range of differing samples. All of the three major analytic methods available today require an extraction/purification stage which is a major source for introducing errors thereby reducing specificity. In fact some studies have found that this step can introduce unexpected variation, more so than the analytical method itself (eg. qPCR) , this increases the risk of having to repeat the analysis for statistically valid data and decreases the reproducibility.
The culmination of these pitfalls above result in higher costs, lower availability and to an extent lower confidence on the ability for miRNA to act as a stable bio-marker in its various uses.
The objective of Phase 1 will be to determine the feasibility, viability and profitability of the product on our company, and to identify the risks and the best strategies for commercialisation. We also aim to point out functional and organisational gaps that need to be addressed and to set up mitigation actions. Our objectives and the activities we plan to undertake in this feasibility study are aligned and consistent with the expected impact of the project in several ways.
