Tecnología
Technology BlaDiMir is an advanced diagnostic system designed for the detection of bladder cancer through the analysis of microRNAs (miRNAs) in urine samples. Below are the technology and scientific principles that support it:
MicroRNAs (miRNAs):
Function: miRNAs are small RNA molecules that play a crucial role in regulating gene expression. Their presence and specific levels in urine can be indicators of bladder cancer.
Detection: BlaDiMir focuses on detecting and quantifying certain miRNAs that are specific and characteristic of bladder cancer.
Diagnostic Process:
Sample Collection: A urine sample is collected from the patient non-invasively.
miRNA Analysis: The urine samples are analyzed in a laboratory using the real-time polymerase chain reaction (qPCR) technique. This technique allows precise quantification of specific miRNAs.
qPCR: qPCR is a standard molecular technique in most laboratories that amplifies and quantifies RNA, providing quick and precise results on the presence of cancer-associated miRNAs.
Interpretation of Results:
Sensitivity and Specificity: BlaDiMir has demonstrated a sensitivity of 90.5% and a specificity of 97%, meaning it is highly effective in detecting bladder cancer and minimizing false positives.
Results: The results of the qPCR analysis are presented as quantitative data indicating whether the miRNA levels are consistent with the presence of bladder cancer.
Technological Advantages:
Non-Invasive: Unlike cystoscopy, which is painful and invasive, BlaDiMir uses only a urine sample, reducing patient discomfort.
Cost-Effective: The cost of BlaDiMir is significantly lower than traditional methods like cystoscopy.
Fast and Accurate: qPCR technology allows for rapid results with high precision, improving early detection and monitoring of bladder cancer.
Application in Treatment:
Prediction of Response to BCG: The advanced version, BlaDiMir+, can also predict patients' response to treatment with Bacillus Calmette-Guérin (BCG), optimizing therapeutic decisions and avoiding unnecessary treatments and their side effects.
Technology
Research and Development
R&D Process:
Biomarker Identification: Research to identify specific miRNAs that are indicative of bladder cancer.
Clinical Validation: Clinical studies to validate the precision and effectiveness of BlaDiMir. This includes comparison with traditional methods and evaluation in different patient cohorts.
Development of Diagnostic Kit: Creation of a diagnostic kit that includes reagents and standardized protocols for performing qPCR on urine samples.
Optimization: Continuous improvements in processes and reagents to increase precision, reduce costs, and facilitate its use in clinical settings.
Patents:
Intellectual Property Protection: BlaDiMir is protected by patent PCT/ES2021/070204, which covers the use of specific miRNA levels for the detection of bladder cancer and the prediction of response to BCG treatment.
Global Coverage: The patents ensure that the technology is protected in multiple jurisdictions, facilitating its international commercialization.
Scientific Publications:
Validation and Results: Studies published in peer-reviewed scientific journals detailing the efficacy of BlaDiMir in detecting bladder cancer. These studies show sensitivity and specificity data, as well as comparisons with traditional methods.
Ongoing Research: Articles describing ongoing investigations into expanding the utility of BlaDiMir, such as identifying new biomarkers or improving the prediction of treatment response.
Scientific Collaborations: Publications co-authored with researchers from academic and hospital institutions, demonstrating collaboration and independent validation of BlaDiMir's results.
