Generating Evidence for the International Commercial Development of the mir-THYpe® full Test: Regulatory, Commercial, and Quality Aspects Focused on Expansion into Europe

• Grant number: 25/02972-7
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: August 01, 2025
• End date: July 31, 2027
• Field of knowledge: Interdisciplinary Subjects
• Principal Investigator: Marcos Tadeu dos Santos
• Grantee: Marcos Tadeu dos Santos
• Associated researchers: Ana Carolina de Oliveira Mafra ; Andrei Félix de Oliveira ; Bruna Frizzo Rabelo ; Bruna Moretto Rodrigues ; Gustavo Bernardes Cavalcante da Costa ; Miriane de Oliveira ; Thamiris Gatti Deo
• Associated research grant: 17/16417-9 - Multicentric characterization and validation of a molecular diagnostic test for the classification of indeterminate thyroid nodules based on microRNA profiling, AP.PIPE

Abstract

The mir-THYpe® full test, commercialized by Onkos Molecular Diagnostics, is a molecular classifier designed to assist in the diagnosis and prognosis of thyroid nodules with indeterminate cytology (Bethesda 3 or 4). It is already widely used in Brazil and Latin American countries, where it has demonstrated a positive impact in reducing potentially unnecessary surgeries and healthcare system costs. As part of the company's international expansion strategy, it was observed that European countries do not currently perform molecular testing for thyroid nodules due to the absence of affordable technologies available on the continent. This gap presents a strategic opportunity for Onkos to enter this market. Thus, the main objectives of this proposal are: A) Obtaining European regulatory certifications (CE-IVD and UKCA), which are essential for commercializing the test in the European Union and the United Kingdom, ensuring compliance with local regulatory standards. B) Obtaining quality accreditations (CLIA and ISO 15189), which certify laboratory excellence and serve as fundamental criteria for the acceptance of the technology by physicians and international healthcare systems. C) Submitting the test to CONITEC (SUS) and expanding access in Brazil, as approval by the Brazilian Unified Health System (SUS) strengthens the technology's credibility and supports future submissions to European healthcare systems. D) Creating awareness and building trust in the brand, by engaging with medical specialists through conferences, symposia, webinars, and scientific publications to ensure the test's prescription and adoption. By the end of this project, the mir-THYpe® full test is expected to be fully compliant with CE-IVD and UKCA regulatory standards, hold CLIA and ISO 15189 accreditations, and have been submitted for CONITEC approval in Brazil. Consequently, the test will be ready for commercialization in the European market, while also paving the way for the company's expansion into other regions. (AU)