Validation in new clinical indications, optimizations and expansion of access and market insertion of the mir-THYpe® test, a molecular classifier of indeterminate thyroid nodules based on microRNA profiling

• Grant number: 21/06579-7
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: November 01, 2021
• End date: April 30, 2023
• Field of knowledge: Health Sciences - Medicine - Pathological Anatomy and Clinical Pathology
• Agreement: FINEP - PIPE/PAPPE Grant
• Principal Investigator: Marcos Tadeu dos Santos
• Grantee: Marcos Tadeu dos Santos
• Company: Onkos Diagnósticos Moleculares Ltda (Filial)
• CNAE: Atividades de serviços de complementação diagnóstica e terapêutica
• City: Ribeirão Preto
• Associated researchers: Andrei Félix de Oliveira ; Bruna Moretto Rodrigues ; Bruno Mari Fredi ; Diego Nogueira Vilela ; Maria Paula Martins Januario ; Mirela Cristina Moreira Prates ; Sandro Paino Paim ; Suzana Rodrigues de Araujo
• 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® exam is a molecular classifier for indeterminate cytology thyroid nodules, developed by the startup Onkos in partnership with the Cancer Hospital of Barretos. It uses advanced molecular biology techniques (microRNA profiling and mutation analysis) and Artificial Intelligence, showing itself capable of reducing potentially unnecessary thyroid surgeries by up to 74.6%. It has already been prescribed by more than 380 Brazilian doctors to more than 1100 patients and has already saved around R$ 3 million to the national health system. The current target market for the test is specifically patients with thyroid nodules, classified as indeterminate (categories III and IV of the Bethesda's system) in the cytological analysis of FNAB (fine needle aspiration biopsy). Although thyroid nodules are very prevalent and frequent in the population, the current target market for the mir-THYpe® test has very limited indication (and validation data), since indeterminate nodules account for only about 20% of all cases. And even within this specific indication (Bethesda III and IV) the market share of the test is still very restricted (less than 5% of the potential market of patients and less than 10% of the potential number of prescribing physicians). Therefore, the objective of the project will be to generate technical data and scientific validation evidence that allow an expansion of the clinical usefulness of the mir-THYpe® test and thyroid cancer biomarkers in new clinical indications, with the consequent increase in the potential market and increase in its availability by paying sources from ATS and cost-effectiveness, in addition to strong investment in Medical Education and Scientific Dissemination. For this, the challenges will be: (A) Technical and scientific that enable an increase in the quality of the test and the potential market (validation of the use of the test for patients with Bethesda 1 nodules, pediatric patients and adolescents, in paraffin slides, and for optimization of the analytical performance of the exam's artificial intelligence algorithm); (B) Economic analysis challenges that make it possible to expand the exam's insertion in the market by claiming the exam's coverage by paying sources (through decentralized and centralized actions, medical education and scientific dissemination, and obtaining quality public certification). All these actions will be carried out in an orchestrated and parallel way so that, together, they make viable not only a greater potential market for Onkos' operations, but also a greater expansion and insertion in these markets. (AU)

Scientific publications

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

SANTOS, MARCOS TADEU; RODRIGUES, BRUNA MORETTO; SHIZUKUDA, SATYE; OLIVERIRA, ANDREI FELIX; OLIVEIRA, MIRIANE; FIGUEIREDO, DAVID LIVINGSTONE ALVES; MELO, GIULIANNO MOLINA; SILVA, RUBENS ADAO; FAINSTEIN, CLAUDIO; DOS REIS, GERSON FELISBINO; et al. Clinical decision support analysis of a microRNA-based thyroid molecular classifier: A real-world, prospective and multicentre validation study. EBIOMEDICINE, v. 82, p. 9-pg., 2022-07-01. (17/16417-9, 21/06579-7)