Molecular test prevents unnecessary thyroid surgery

By Elton Alisson  |  FAPESP Innovative R&D – A diagnostic test developed by a startup in Ribeirão Preto, in the interior of the state of São Paulo, Brazil, helps identify and classify thyroid nodules. The test prevents patients with suspected endocrine gland cancer from undergoing unnecessary surgeries and procedures.

Created by Onkos, the test has been available on the market since 2018 and has already been sold in more than 30 countries. It can differentiate between benign and malignant nodules through a combination of molecular analysis and artificial intelligence tools.

The molecular test, called mir-THYpe and developed with support from FAPESP’s Innovative Research in Small Businesses Program (PIPE), uses biomarkers to confirm or rule out the presence of cancer in thyroid nodules with indeterminate results.

According to Marcos Tadeu dos Santos, founder of the company, the vast majority of nodules are benign, but up to 30% of them are classified as “indeterminate.” For safety reasons, the standard procedure in these cases is surgery to remove the thyroid. However, only 25% of cases are malignant, meaning that 75% of surgeries for indeterminate nodules are potentially unnecessary.

“At certain points in their journey, the cancer patients are faced with what we call diagnostic uncertainties, which lead them to undergo unnecessary procedures, surgeries, and treatments. We identified some of these gaps and planned the development of diagnostic tests using molecular biology and artificial intelligence to solve these patients’ problems,” says Santos.

A study published in The Lancet Discovery Science showed that the test was capable of averting almost 75% of unnecessary surgeries. “We estimate that the test was responsible for avoiding at least 4,000 unnecessary thyroid removal surgeries in patients with indeterminate nodules, and as a result, we have helped save expenses of up to BRL 7 million with health insurance,” he stresses.

Competitive advantages

According to the researcher, there are currently three technologies competing with the test offered by Onkos, which was developed in the United States. One competitive advantage of the Brazilian test, however, is its cost – it is one-third to one-quarter of the price charged by foreign competitors.

Another advantage of mir-THYpe is that the tissue sample from the nodule does not need to be refrigerated for analysis. “For this reason, we’re able to bring samples from anywhere in the world to Ribeirão Preto and perform the tests here,” says Santos.

In addition, the patient does not need to undergo a new biopsy for the test. “For other tests, the patient needs to return to the laboratory and undergo a new biopsy when the nodule is classified as indeterminate,” he compares.

Europe is considered a promising market for the test since the European Thyroid Association (ETA) published an official recommendation in 2024 for using molecular tests to diagnose thyroid nodules classified as indeterminate, such as the one developed by Onkos. However, the solution is not yet available in Europe.

“That’s why we’re looking closely at the European market now, because there’s a demand. But there are a number of regulatory issues that we need to overcome,” said Santos. The company has been conducting clinical studies of the test in countries such as England and Spain to validate its use in the European population. During his trip to France, Santos plans to establish contacts with research centers, hospitals, and laboratories in the country to continue this work.

According to the researcher, Onkos has just been accredited by the College of American Pathologists (CAP), the world's most rigorous and important seal of laboratory excellence – only seven other Brazilian laboratories have been awarded the seal. “That proves we're on the right path.”

“Other deeptechs [science and technology-based startups] also need to move toward internationalization, learn the ropes, and then come back and teach others, so that this flow increases. We want to stop exporting soybeans and importing iPhones,” says Santos.