Periodic Reporting for period 1 - LIVELMIA (Innovative assay for microRNAs analysis)
Reporting period: 2019-09-01 to 2020-02-29
• 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.
LIVELMIA is supplied to our customers in a kit. The kit is made up of a number of sample holders (called wells) in which we anchor our probe molecules that capture the target miRNA in the sample. Once a sample (blood, plasma, cells) are placed in the well, the users adds our labelling buffer. The labelling buffer translates the level of miRNA in the sample into a change in light absorption of certain colour. This is then measured, instantly, using a spectrophotometer which is standard equipment which any lab would have.
a) Probes designed for high specificity and sensitivity for targeting of specific miRNAs with a signalling system
b) Optimized reagents (buffer solutions) and analytical procedure to reduce overall time and cost;
c) A platform for rapid design of kits targeting new miRNAs of clinical interests.
Overall, the unique features of LIVELMIA assay are ideal for miRNAs analysis. Our innovation, when compared to the competitors:
• Saves time/ease of use: No sample extraction/purification and preparation, analysis directly on the sample;
• Provides high biological and chemical stability: LIVELMIA’s components do not degrade in a biological sample
• LIVELMIA is the only method that directly protects miRNAs from degradation by sample components;
• High affinity and specificity: increased reliability, consistency, accuracy of miRNA analysis thanks to approximately 25% greater affinity and specificity for the target;
• Easy standardization: Works efficiently in different environments and difficult sample types (living cells, blood, plasma, etc).