MiRacle is a groundbreaking startup focused on transforming disease diagnostics using microRNA analysis. Our innovative method offers a non-invasive, cost-effective, and highly accurate solution for early-stage disease detection. By leveraging our proprietary technology, we aim to revolutionize the field of diagnostics and save countless lives.

Problem: Accurate diagnosis is a prerequisite for efficient health care. Ideally, if signs of pathogenesis could be detected before or at early stages of disease onset, then effective intervention and treatment may be administered. However, standard diagnostics are invasive, expensive, and often inaccurate. We have identified a better alternative through the analysis of the expression of microRNA molecules in bodily fluids. Many disease states are associated with aberrations in expression of few microRNA (miR) molecules^1,2
MiRs are abundant in bodily fluids, and their expression levels are directly responsive to disease progression. Importantly, monitoring the expression levels of small panels consisting <10 miR targets is specifically indicative of disease state^3-5, providing a unique access point for accurate and sensitive diagnosis with a simple blood draw. However, existing methods for microRNA quantification are inherently prone to bias due to PCR-amplification which does not maintain the original copy number distribution of target RNA species in the sample. Moreover, they are labor-intensive, time-consuming, and expensive, hindering their widespread adoption.

Solution: MiRacle has developed a sensitive method capable of counting panels of up to 10 microRNAs at single-molecule resolution. Our revolutionary approach provides fast turnaround times (approximately 2 hours) and significantly lowers the cost per test compared to standard methods (up to 1/1000th the cost).

Key Benefits:
• Low-cost solution with exceptional sensitivity and accuracy
• Requires a minimal amount of peripheral blood per test
• Fast turnaround time from test to answer (approximately 2 hours)
• Fully automated process with AI-powered diagnosis
• Flexibility to adapt to any disease by changing the microRNA targets without hardware or software modifications

Technology Overview: The MiRacle workflow involves extracting small RNA from a blood plasma sample and mixing it with uniquely labeled DNA probes designed to complement the selected microRNA targets. The resulting RNA:DNA complexes are captured on a functionalized microscope surface using specific antibodies. We utilize a novel spectral imaging system6 to visualize and count all 10 probes simultaneously at a single-molecule resolution. Machine learning algorithms then analyze the images, providing an expression profile for diagnosing the disease state in the patient.

Founders and Expertise: MiRacle was founded by Dr. Jonathan Jeffet (Ph.D. in Physics) and Prof. Yuval Ebenstein (Physical Chemistry and Biomedical Engineering Dept.) from Tel Aviv University. With their expertise in single-molecule microscopy and epigenetics, they spearhead our pioneering efforts. The prototype was initially developed by Jonathan as part of his Ph.D. studies.

IP: provisional patent secured 

Current Stage: MiRacle is currently in the ideation stage, having validated a technical MVP using synthetic microRNA molecules. The next milestone is to conduct clinically relevant experiments within the next 6 months.

References:
1. Byron, S. A., Van Keuren-Jensen, K. R., Engelthaler, D. M., Carpten, J. D. & Craig, D. W. Translating RNA sequencing into clinical diagnostics: opportunities and challenges. Nature Reviews Genetics 2016 17:5 17, 257–271 (2016).
2. Iorio, M. V. & Croce, C. M. MicroRNA dysregulation in cancer: diagnostics, monitoring and therapeutics. A comprehensive review. EMBO Molecular Medicine 4, 143–159 (2012).
3. Fernandez-Mercado, M., Manterola, L. & Lawrie, C. MicroRNAs in Lymphoma: Regulatory Role and Biomarker Potential. Current Genomics 16, 349–358 (2015).
4. Abdallah, H. Y. et al. Identification of a circulating microRNAs biomarker panel for non-invasive diagnosis of coronary artery disease: case–control study. BMC Cardiovascular Disorders 22, 1–17 (2022).
5. Jørgensen, S. et al. The value of circulating microRNAs for early diagnosis of B-cell lymphoma: A case-control study on historical samples. Scientific Reports 10, 1–11 (2020).
6. Jeffet, J. et al. Multimodal single-molecule microscopy with continuously controlled spectral resolution. Biophysical Reports 1, 100013 (2021).