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 carrying out three trials:

  1. EASY-TEST – a trial which assesses the sensitivity and specificity of a test for the diagnostics of prostate cancer.
  2. PANURI – a trial which assesses the sensitivity and specificity of a test for the diagnostics of pancreatic cancer.
  3. FINDER – preliminary indication of medical conditions for further trials on the sensitivity and specificity of a medical device for different types of cancer.

EASY TEST – prostate cancer

A multicentric, open scientific experiment which assesses the usefulness of a new test related to the diagnostics of prostate cancer.

Purpose of the experiment

The purpose is the assessment of diagnostic parameters (sensitivity and specificity) of the Urteste medical device using urine samples from diagnosed patients divided into three groups, i.e. patients with prostate cancer, patients with conditions other than cancer (prostatitis, benign prostatic hyperplasia) and healthy volunteers. 

Experiment plan

The scientific experiment assesses the sensitivity and specificity of the new Urteste test for the diagnostics of prostate cancer. The experiment involves patients with histopathologically confirmed prostate cancer, patients diagnosed with cancer conditions of the prostate and healthy volunteers.

The experiment involves the collection of two urine samples. The samples are blinded and sent to an independent laboratory for analysis using the Urteste test. Additionally, a blood sample is collected from the participants for a PSA test.

Population

The number of patients involved in the scientific experiment is 165, aged 18 years or over. Participants are assigned to one of three arms:

  1. 55 patients with prostate cancer
  2. 55 patients with benign prostatic hyperplasia or prostatitis
  3. 55 healthy volunteers

Endpoints

Primary endpoints

  1. Assessment of the sensitivity of the new test
  2. Assessment of the specificity of the new test

Secondary endpoint

The correlation between the results obtained using the new URTESTE test and the PSA test results can then be calculated. Based on this, the sensitivity and specificity of both diagnostic methods will be compared.

PANURI – Pancreatic cancer

A multicentric, open scientific experiment using an Urteste medical device – a test for the diagnostics of pancreatic cancer in patients diagnosed with pancreatic cancer, patients with pancreatitis and in healthy volunteers, which aims to determine the sensitivity and specificity of the examined medical device.

Purpose of the experiment

The purpose is an assessment of the diagnostic parameters (sensitivity and specificity) of the Urteste medical device using urine samples from diagnosed patients divided into three groups, i.e. patients with pancreatic cancer, patients with pancreatitis and healthy volunteers.

Experiment plan

The experiment involves participants diagnosed with pancreatic cancer, patients diagnosed with pancreatitis and healthy volunteers. The experiment involves the collection of samples of the participants’ urine. The samples are blinded and sent to an independent laboratory for analysis using the Urteste test.

Endpoints

Primary endpoints

  1. Assessment of the sensitivity of the new marker in patients diagnosed with pancreatic cancer.
  2. Assessment of the specificity of the new marker in patients diagnosed with pancreatic cancer.

Secondary endpoint

  1. A comparison of the sensitivity and specificity of the Urteste and CA19-9 marker in patients with pancreatic cancer.

Population

The planned number of patients involved in the scientific experiment is 330, aged 18 years or over. Participants are assigned to one of three categories

  1. 110 patients with pancreatic cancer
  2. 110 patients with pancreatitis
  3. 110 healthy volunteers

FINDER

An open scientific experiment using a test for the rapid diagnostics of cancers, with the aim of establishing preliminary indications of medical conditions for further trials on the sensitivity and specificity of the Urteste tests.

Purpose of the experiment

The FINDER project is a multicentric scientific experiment to monitor the prospective medical device, which is open for researchers and blinded for the laboratory tests.

The purpose is the preliminary indication of medication conditions for further research on the sensitivity and specificity of the prospective Urteste medical device, using urine samples obtained from patients diagnosed with oncological conditions. 

The target number of participants in the research experiment is several thousand patients.

Inclusion criteria

  1. diagnosed colorectal cancer
  2. diagnosed kidney cancer
  3. diagnosed lung cancer
  4. other diagnosed cancer

Experiment endpoints

  1. Assessment of the sensitivity of the new marker in patients diagnosed with cancer.
  2. Assessment of the specificity of the new marker in patients diagnosed with cancer.