The test will allow non-invasive detection of micrometastases

The startup, with support from PIPE-FAPESP, develops a solution that detects a biomolecule associated with the presence of migrating oral cancer cells (Photo: Disclosure: Clunes)

The test will allow non-invasive detection of micrometastases

April 16, 2024

Rosselli Andrion | Research for innovation The ability to identify micrometastases in cancer patients could be an important differentiator in treatment. In many cases, invasive interventions can be avoided and help maintain quality of life.

The solution developed by the startup Clyons Diagnóstica could help achieve this goal in patients with oral cancer. The startup is evolving with supports From the program Innovative research in small businesses (Pumping), from FAPESP, is a test capable of detecting a biomolecule related to the presence of micrometastases of oral squamous cell carcinoma. “We have been able to prove the concept and have already started to reap some rewards,” says the chemist. Thiago Pradoco-founder of the company.

The proof of concept, obtained in synthetic samples, mimics the presence of the biomolecule in living organisms. According to the researcher, the team is now working on a pilot test to create a minimum viable product (MVP) in a hospital environment.

To this end, it has concluded a cooperation agreement with the Department of Head and Neck Services of Hospital d'Amour and Hospital Harina Inovção, both in Barretos. “We expect to perform clinical analytical validation on patient samples,” says Prado. “This will include head and neck surgeons and professionals from the Department of Pathology and the Teaching and Research Center at Hospital d’Amour.”

This analytical clinical validation aims to apply the Clyons methodology in a controlled environment – ​​in this case, patient samples from the partner health unit. “At this stage, we will confirm the presence of the mark in the patient, which is necessary to launch a health product on the market,” explains Prado.

Researchers are seeking to protect the intellectual property of the innovation and have already begun writing a patent for the technology.

Slightly invasive

According to Prado, it is common for patients with cancer in the lower part of the mouth or neck to remove the sentinel lymph node or electively remove all lymph nodes in the neck. “In 70% to 80% of patients who undergo this procedure, no metastases are found and the individual can be preserved,” Prado assessed.

Often times, this procedure is irreversible and affects the lymphatic system of the neck and muscles in the area. “It can also cause paralysis, loss of shoulder movements, changes in voice and taste, difficulty swallowing and more – in other words, it has the potential to significantly impact a patient's health. Not to mention the costs involved.”

On the other hand, in early tumors, follow-up may be an option, and sometimes, disease progression is not detected because there is no more in-depth investigation. “In 20% to 30% of cases, it is found that there are micrometastases that have not been investigated and the individual is diagnosed with cervical cancer, which is already at an advanced stage.”

The test proposed by Cleunes, in turn, is less invasive than surgical procedures, in addition to being very sensitive and accurate. Therefore, it can be used in patients at different stages of the disease. By puncturing a lymph node, researchers obtain a highly representative sample of the area, something that may not be possible when collecting material for histopathology examination, for example.

Early detection of micrometastases can alter treatment management. This technology is so promising that Prado explains that, in the future, the startup intends to adapt the process of identifying biomolecules to other types of cancer. “This is the case, for example, for breast and thyroid cancer, among others.”

Diagnostic assistance

Prado highlights that Clyons' technology is as sensitive and precise as others on the market, but has fewer sample processing steps. This reduces the time and cost to achieve the result. “For application in disease diagnosis, it is an incremental solution: it will provide additional information to help determine the clinical condition of the patient.”

During the process, the biomarker is captured in a solid phase and then released into a liquid medium for detection. In this process, biochemical reactions occur in a heterogeneous environment (solid/liquid), allowing pre-concentration of the biomolecule. The scientist points out that this increases the sensitivity of the analysis method.

Public Health

According to Prado, oral cancer is a topic of public health care, especially for the Unified Health System (SUS), because the risk factors are alcohol consumption and smoking. He highlights that “a large portion of the Brazilian population has smoking and alcohol consumption habits.”

Data from the National Cancer Institute (INCA) indicate that between 2023 and 2025, 118,650 cases of head and neck cancer are expected to appear in the country – an average of 39,550 cases per year. In general, this disease is among the ten most common diseases in this category. As for men, oral cavity cancer ranks fifth in terms of incidence. In women, the trachea and thyroid gland occupy fourth and fifth places, respectively.

In the long term, scientists anticipate the possibility of identifying biomolecules in peripheral blood through liquid biopsy. “This will allow us to detect diseases systematically, and not just in specific areas of metastasis.”

The team expects to win the Most Valuable Player award within a maximum of two years. “Then there are some processes to move the technology from research to development to market. This is the case, for example, for regulatory approval: we have no control over the time it takes to issue this registration.

From university to everyday life

Clyons was founded in June 2022 and the initiative sought to improve and apply the knowledge gained by researchers in their academic careers. “The head and neck cancer molecule diagnostics project started at the university, and we are currently continuing it here at the company,” says Prado. “Our experience has always included studying biomolecules associated with this disease.”

Even the startup's name links academic research to everyday life. That's because it's a tribute to the researchers who discovered biosensors: biochemist Leland Clark and microbiologist Champ Lyons. They developed the first biosensor in 1962 and the research led to the creation of the glucometer – which allows blood glucose levels, especially in diabetics, to be controlled on a daily basis around the world.