Test classifies thyroid nodule with superior sensitivity

By Eduardo Geraque  |  FAPESP Innovative R&D – Brazilian startup Onkos Diagnósticos Moleculares has developed a diagnostic test for thyroid nodules that promises to be more sensitive than the tests available on the market.

Developed with support from the FAPESP Innovative Research in Small Business Program (PIPE), the test detects whether a thyroid nodule classified as indeterminate by existing techniques is benign or malignant, reducing the risk of false-positives and false-negatives. The molecular test avoids unnecessary surgery, since some 30% of tests performed currently in Brazil to detect cancer in thyroid nodules have an indeterminate result, and in as many as 84% of these the lump turns out to be benign, the firm’s data shows.

“Another advantage of our test is that ours doesn’t require the patient to undergo another fine needle aspiration, which is always uncomfortable, and samples can be transported at room temperature,” Marcos Tadeu dos Santos, the firm’s founder, told Innovative R&D. Onkos is incubated at the Supera Technology Innovation Park in Ribeirão Preto, in the state of São Paulo.

Development of the test began in 2015 in partnership with Barretos Cancer Hospital. The test was launched in 2018 and could be accredited in the coming months by Brazil’s National Supplementary Health Agency (ANS), which regulates the medical insurance sector. ANS received 1,200 proposals in response to its latest call in 2018, and only 84 made it to the most recent stage of the analysis. One of these was the test created by Onkos. If it passes scrutiny, it will be covered by health insurers.

The firm also aims to win approval for the test from the SUS, Brazil’s national health service. “Approval will mean savings for both health insurers and the SUS because unnecessary thyroidectomies will be avoided,” Santos said.

Meanwhile, the test is available privately. When the result of fine needle aspiration is indeterminate, the patient takes a doctor’s prescription to Onkos or one of the laboratories that partner with the firm.

“Clinical labs send the samples they collect to us. We do the test on our platform and return the results to them,” Santos said.

The firm has performed over 1,000 tests to date, using samples from every region of Brazil. The result of the test typically reaches the prescribing physician in less than a fortnight.

Scientific difference

According to Santos, the test’s key scientific difference is that it identifies the genetic signatures of any tumor cells present in the thyroid. AI algorithms then interpret these molecular signatures to arrive at a positive or negative result with a high degree of accuracy.

The test uses real-time PCR to analyze the expression of 11 microRNAs in indeterminate nodules, with a predictive value of 96% for negative results. A recent prospective study conducted by the firm involved 435 patients and found a 75% reduction in unnecessary thyroidectomies.

“Only four firms in the world currently solve this problem: three in the US and ourselves in Brazil,” Santos said.

In future, the platform can be adapted to other types of cancer, such as breast and prostate cancer. “Our logistical structure enables us to service any Brazilian city,” Santos said.

In Brazil, 13,780 new cases of thyroid cancer per year will be reported on average between 2020 and 2022, according to the National Cancer Institute (INCA); 1,830 will be male and 11,950 female. In 2018, again according to INCA, 566 women and 271 men died of complications resulting from thyroid cancer.