Tecnology

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, BlaDimiRplus, can also predict patients' response to treatment with Bacillus Calmette-Guérin (BCG), optimizing therapeutic decisions and avoiding unnecessary treatments and their side effects.

Technology

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.

Research and Development

Patents:

• To protect our intellectual property, an initial Spanish patent was filed with the Spanish Patent and Trademark Office (OEPM):
  ES2856232A1 – filed on March 25, 2020 – and published with a positive national prior art report (IET).
  In 2021, we submitted an international PCT application (WO2021191485A1).
  The International Search Report (ISR) issued a written opinion concluding that all claims appear to meet the inventive step requirement (Article 33(3)) and novelty requirement (Article 33(2)) of the PCT.

  In 2022, the PCT application entered the national phase in Europe (EP4112745A1) and the United States (USPTO, publication pending).
  This patent was awarded by the OEPM in 2025 for its innovation and potential impact.

Scientific Publications:

• Suarez-Cabrera C, Estudillo L, Ramón-Gil E, Martínez-Fernández M, et al.
  BlaDimiR: A Urine-based miRNA Score for Accurate Bladder Cancer Diagnosis and Follow-up.
  European Urology, 2022 Dec; 82(6):663-667.
  https://doi.org/10.1016/j.eururo.2022.08.011
  PMID: 36085102.

• Martínez-Fernández M, Paramio JM, Dueñas M.
  RNA Detection in Urine: From RNA Extraction to Good Normalizer Molecules.
  Journal of Molecular Diagnostics, 2016 Jan; 18(1):15-22.
  https://doi.org/10.1016/j.jmoldx.2015.07.008
  PMID: 26586227.

Scientific Collaborations:

• Carvalho S, Abreu CM, Ferreira D, Lima L, Ferreira JA, Santos LL, Ribeiro R, Grenha V,
  Martínez-Fernández M, Duenas M, Suárez-Cabrera C, Paramio JM, Diéguez L, Freitas PP, Oliveira MI.
  Phenotypic Analysis of Urothelial Exfoliated Cells in Bladder Cancer via Microfluidic Immunoassays:
  Sialyl-Tn as a Novel Biomarker in Liquid Biopsies.
  Frontiers in Oncology, 2020 Sep 16; 10:1774.
  https://doi.org/10.3389/fonc.2020.01774
  PMID: 33042825

Patents & Scientific Publications