Point-of-care device for investigation and diagnosis of prostate cancer

• Grant number: 22/07664-0
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: November 01, 2022
• End date: July 31, 2023
• Field of knowledge: Physical Sciences and Mathematics - Chemistry - Analytical Chemistry
• Principal Investigator: Thiago Martimiano do Prado
• Grantee: Thiago Martimiano do Prado
• Company: Clyons Pesquisa e Desenvolvimento em Biotecnologia Inova Simples (IS)
• CNAE: Pesquisa e desenvolvimento experimental em ciências físicas e naturais
• City: São Carlos
• Associated researchers: Matias Eliseo Melendez ; Ronaldo Censi Faria
• Associated scholarship(s): 22/15237-5 - Point-of-care device for screening and diagnosis of Prostate Cancer, BP.PIPE

Abstract

Prostate cancer is the second most common type of cancer in men worldwide, second only to skin cancer (non-melanoma). Investigation and diagnosis are currently performed with the aid of a digital rectal examination of the prostate (DRE), quantification of prostate-specific antigen (PSA) in a blood sample and biopsy procedures. Often, changes found in DRE and PSA quantification suggest unnecessary biopsies in situations in which increased prostate size and PSA elevation are related to benign inflammation of the prostate, known as prostatitis. The company Clyons Diagnóstica is a startup whose purpose is to develop an innovative point-of-care diagnosis that will allow for the indication of biopsy in cases with a higher probability of prostate cancer. The analyzes will be performed on an aliquot of blood (about 70 µL) which can be collected in a non-invasive way on the patient's fingertip and the results will contribute to the reduction of unnecessary biopsies. The test results are based on the quantification of three different isoforms of PSA found in blood, complexed PSA, free PSA and p2PSA (protein biomarkers of the kallikrein class). The test to be developed will allow multiplexed detection of the three biomarkers using specific antibodies and magnetic particles for capture, separation and detection of targets. The great advantage of the product will be the ability to quantify multiplexed biomarkers in the same sample, quickly, with low cost and portability. For this, two strategies will be evaluated for the detection of biomarkers involving different analytical techniques, in this case electrochemical and spectrophotometric techniques. The correlation between the levels of each biomarker in the blood will provide important information about the health of the prostate, bringing more security to the doctor for the indication of biopsy in the case of suspected prostate cancer and also for the follow-up of the treatment of patients already diagnosed with the disease. With the availability of the device for performing examinations in urology offices and hospitals during patient care, decision-making on each case will become agile and effective and will avoid unnecessary biopsies. These characteristics highlight the disruptive character of the product intended for the diagnostics market. The product will allow a new business model with direct marketing to offices, clinics and hospitals, decentralizing analyzes carried out by specialized laboratories, but which will also be able to make use of the device. (AU)