The results of a new clinical study have confirmed the high accuracy of an innovative diagnostic test for identifying and classifying thyroid nodules.
With greater sensitivity than conventional methods, the test, developed with the support of FAPESP, a São Paulo company, Onkos Diagnostics Moleculares, has been shown to be able to prevent a large number of unnecessary surgeries.
The mir-THYpe molecular test, marketed since 2018, uses biomarkers to confirm or rule out the presence of cancer in thyroid nodules that have indeterminate results. The information comes from the FAPESP Agency.
How it works?
When a nodule is identified in the thyroid, according to Marcos Tadeu dos Santos, founder of the company, the technique used today to assess whether or not there is cancer is a aspiration puncture, with the removal of blood material. the patient’s neck area for analysis.
“The vast majority of nodules are benign, but up to 30% of them are classified as ‘undetermined’ and, in these cases, for safety reasons, the standard procedure is surgery to extract the thyroid. However, only 25% of cases are malignant and this means that 75% of surgeries in case of indeterminate nodules are potentially unnecessary, ”he explains.
According to Santos, after the thyroid gland is removed, the patient must undergo hormone replacement procedures for the rest of his life. Thus, unnecessary surgeries not only have a direct economic impact, straining public and private health systems, but also generate indirect costs and long-term damage to the health of the patient.
In the latest study, researchers from Onkos followed 440 patients who underwent the new test for two years in all regions of Brazil. “We have managed to avoid 75% of surgeries that would be performed unnecessarily. Another result is that in 92% of cases, the use of the test changed the clinical conduct of doctors, ”Santos said. The study, presented this year at the Brazilian Thyroid Meeting, was published on the medRxiv platform, but without peer review.
The main scientific difference of the new test, according to Santos, is that it allows the identification of the main genetic signatures of tumor cells present in the thyroid. From these markers, algorithms using artificial intelligence decipher the molecular signatures of the tumor and give the result with great precision. The test analyzes the expression of 11 microRNAs by real-time PCR, with an accuracy of 96%.
“In addition to the diagnostic markers – which are used to determine whether the nodule is benign or malignant – we added to the examination, in 2021, a few other genetic markers of a prognostic nature, that is to say that they allow us to determine the aggressiveness of the tumor, ”says Santos.
According to him, identifying the aggressiveness of the tumor is essential to determine the planning of the surgery to be performed. “Thyroid cancer is generally not very aggressive. In these cases, the doctor may opt for more conservative surgery than those recommended for more aggressive malignant nodules, ”he explains.