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Update and optimization of the TOT molecular test (tumor origin test) for metastatic tumors of unknown primary origin through multi-omic approaches

Abstract

Unknowing about the primary site of a metastatic disease, that is, its place of origin, categorizing itself as a cancer of unknown primary site (CUP) makes it difficult to target specific treatments to the patient. CUP is 2% of all cancer diagnoses worldwide and is among the top ten causes of death from cancer. The CUP cases share common characteristics such as rapid dissemination, increased aggressiveness, poor prognosis, and an unpredictable metastatic pattern, and approximately 80% of patients do not respond to chemotherapy and have a survival rate between six and ten months. Targeted therapy directed to the patient, whose selection is determined by information acquired by molecular approach, gene expression profile and gene sequencing, can significantly improve treatment results. Based on the molecular approach, Dr. Marcos Tadeu dos Santos, founder of the startup Onkos Diagnostic Molecular, in partnership with the Barretos Cancer Hospital (HCB), Fleury Medicina e Saúde and the Federal University of Maranhão (UFMA), developed and launched in 2017 the first version of the Tumor Origen Test (TOT). The Fleury Group added the exam to its portfolio of molecular examinations in the oncology menu. However, in 2021, due to the notice of discontinuation by the manufacturer of a "key" reagent for the analysis of the samples, thus requiring a new technical validation of the examination with a substitute reagent, added to the need for updating (requested by several client oncologists) in the face of technological advances in recent years, the Fleury Group chose to prioritize its current financial and R&D human resources efforts in other exams of its portfolio with markets and therefore interrupt the offering of the TOT exam. Given this, Onkos expressed interest in "redeeming" the exam for the purpose of providing a new, enhanced and updated version of the test for CUP patients. With the technical-scientific efforts employed by the Onkos research team, an optimized NEW VERSION of the TOT exam will be validated, and, in order to complement the exam, we will add the use of NGS to identify actionable mutations related to CUP, integrating the exam to the Onkos portfolio. Molecular tests available in Brazil are offered by private laboratories and have specific cancers as their market, not being indicated for CUPs. The proposed exam, TOT, in this proposal will be carried out in Brazil with the price for the diagnostic service of this exam of approximately R$6000 (with the possibility of installment payment). None of the competitors performs the exam in Brazil, and the sample must be sent internationally. The doctor, at the patient's request, can place the order through the forms on the international laboratories' online platform, and send the sample to be analyzed to reference laboratories outside Brazil, however, these tests have a turnaround time for releasing results of up to 40 days and can cost from R$ 12,500.00 to approximately R$ 45,000.00, thus limiting and restricting their use and access to the Brazilian population. We intend to optimize the discrimination power between CUP samples of the current gene expression classifier by improving the algorithm, in order to obtain more sensitive and specific results, in addition to complementing with mutational testing through NGS, focusing on a panel of actionable mutations. (AU)

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