Trials

Research and development programme

Urteste carries out trials with the aim of developing tests for early cancer detection. The know-how created by the company and the results lead to the effective development of more tests. The company has a library of compounds having diagnostic potential and a bank of samples. Individual tests are developed in three stages. During the first stage, laboratory tests are carried out using samples, during which hundreds of selected marker compounds are tested in detail to indicate the compound with the greatest diagnostic potential.

During the second stage of the trials, pilot trials are carried out using the indicated compound. The aim of this stage is to preliminarily confirm the sensitivity and specificity parameters of a diagnostic test based on the compound indicated during the previous stage. The trials are carried out by centres and independent diagnostic laboratories. After satisfactory results are obtained, the last stage involves confirming the final usefulness of the diagnostic tests by multicentric, international trials, which will help register a medical device for in vitro use (IVD).

Urteste is currently conducting two projects:

  1. PANURI
  2. MULTI-CANCER

PANURI – pancreatic cancer

Urteste’s most advanced project is PANURI – the pancreatic cancer test.

PANURI is a qualitative in vitro diagnostic assay intended for examination of urine samples collected from the human body to provide information about physiological or pathological conditions.

 

A research experiment was completed in March 2022.

Purpose of the experiment

The purpose of the research experiment was to assess the sensitivity and specificity parameters of the test and to compare the sensitivity and specificity of the test with respect to the CA19-9 marker used in patients with pancreatic cancer.

Clinical population

The experiment involved a total of 322 participants divided into three groups:

  1. patients with pancreatic cancer,
  2. patients with pancreatitis,
  3. healthy volunteers.

The research experiment and the final report from the experiment were conducted by an independent company. CRO (Contract Research Organization). The experiment was conducted in 13 medical centres.

Results of the experiment

The conducted study of the diagnostic test for pancreatic cancer (PANURI) resulted in:

  • high sensitivity amounting to 95.6%.
  • high specificity amounting to 95.5% in the group of pancreatic cancer patients with respect to healthy people.

In the opinion of the Issuer’s Management Board, the obtained PANURI results are promising and compliant with the assumptions of the study. They also confirm the concept of the test as a tool for an early diagnosis of pancreatic cancer.

The Management Board and the Scientific Council of Urteste emphasise that the PANURI project is a priority project due to the biggest, in the assessment of the Management Board, market potential.

The study showed a correlation of the PANURI results with the results of the CA19-9 test used in the diagnostics of pancreas, amounting to 67.6%. A relatively limited correlation is due to the fact that the sensitivity of the CA19-9 marker is on a low level and in the PANURI study amounted to 66.1%.

Comparison of the patients with pancreatic cancer with the healthy patients confirms the assumptions of the test, and the obtained results of sensitivity and specificity in relation to the people with pancreatitis confirm the preliminary usefulness of the test in the clinical practice. In the opinion of the Management Board of the Company the obtained results confirm the legitimacy to continue the project. On the basis of the obtained results, a final test prototype will be developed and a clinical trial will be designed, which will be used for certification of the future IVD medical device (In Vitro Diagnostics), which will in turn enable to introduce this device to the market.

In the opinion of the Management Board and the Scientific Council, the results obtained from the study, relating to the sensitivity and specificity parameters, confirm the significant diagnostic potential of the Urteste technological platform for an early diagnosis of cancer and its efficiency in conditions similar to the real environment.

MULTI-CANCER

MULTI-CANCER represents a diverse portfolio of Urteste’s research projects. The company is dedicated to developing tests for dozens of the most common cancers. Currently, Urteste has 12 prototype diagnostic tests.

A component of the MULTI-CANCER project is the completed, standalone EASY-TEST project involving research on a test to detect prostate cancer.

A medical experiment as part of the EASY-TEST (diagnostic test for prostate cancer – sub-project in MULTI-CANCER) was completed in December 2021.

Purpose of the experiment

The purpose of the experiment was to assess the sensitivity and specificity of the test, as well as to compare these parameters to the PSA marker, which is commonly used in patients with prostate cancer.

Clinical population

The research experiment involved 164 participants in three groups:

  1. patients with prostate cancer
  2. patients with prostatitis or benign prostatic hyperplasia
  3. healthy volunteers

The research experiment along with its final report were performed by an independent contract research company, known as a Contract Research Organization. The experiment was carried out in five different medical centres.

Results

The research on the diagnostic test for prostate cancer (EASY-TEST) showed:

  • high sensitivity of 90.9%,
  • high specificity of 93.5% in the group of patients with prostate cancer compared to healthy volunteers.

Urteste Management Board considers the results of the EASY-TEST promising and compatible with the objectives of the research, also claiming that these results confirm the concept of the test as an instrument for an early diagnosis of prostate cancer.

The research showed high correlation of 89.4% between the results of the EASY-TEST and, commonly used in the prostate diagnosis, PSA test. The interpretation of the results is easier in the case of EASY-TEST because the test is either positive or negative.

The comparison of patients with prostate cancer to healthy volunteers confirms the assumptions of the test. The sensitivity and specificity parameters of patients with benign prostatic hyperplasia confirm the preliminary usefulness of the test in clinical practice.

In the opinion of the Company’s Management Board, the obtained results confirm the validity of the project continuation. On the basis of the results, a final prototype of the test will be developed along with the clinical trial, which will be used for certification of a future IVD (In Vitro Diagnostics) medical device, which in turn will allow the product to be marketed.

The Management and Scientific Boards of the Company state that the results of sensitivity and specificity parameters obtained in the research prove a significant diagnostic capacity of the Urteste technology platform used for an early cancer diagnosis and its effectiveness in a close to reality setting.