BBMRI.PL: Publication in The Lancet Digital Health for the Molecular Pathology Centre Cellgen

The worldwide first prospective clinical study on the prediction of COVID-19 disease course has been completed and was published in the leading journal THE LANCET Digital Health on 31 August 2022. DOI:https://doi.org/10.1016/S2589-7500(22)00150-9

The study is the result of cooperation between Medizinische Hochschule Hannover (MHH) and international research centres (including Molecular Pathology Center Cellgen, Wroclaw). Łukasz Fuławka, MD, Monika Litwin, PhD and Patrycja Marciniak from Cellgen laboratory were involved in the patients enrolment and samples collection.

THE CoV50 TEST

„The proteome test enabled prediction of severe disease courses from the first day of the COVID-19 diagnosis and consequently efficient use of drugs against the SARS coronavirus-2 (SARS-CoV-2)” says Prof. Joachim Beige, head physician of the Clinic for Nephrology at St. Georg clinic in Leipzig and principal investigator of the COVID-19 study (CRIT-CoV-U).

„This proteomic test is a real milestone in the efficient and timely detection of complication-prone COVID-19 patients and can help significantly reduce the burden of this pandemic disease via accurate prognosis and therapy management. In addition, the use of this test can save significant costs for the healthcare system.”

The CoV50 proteome test is the first urine test that can predict severe COVID-19 course already at the first detection of SARS-CoV-2 infection and that has proven performance in a prospective study. It demonstrated predictive power (AUC) of prognosis of over 80% on the „hard endpoint” – death. This opens up the possibility of targeted, personalised therapy. All therapeutic agents for the treatment of COVID-19 are only effective in the early phase, when the further course of the infection cannot be predicted with certainty. Based on the excellent performance, the CoV50 proteome test has been approved as in-vitro diagnostic in Germany and is available for patients in the EU.

STUDY RESULTS

The clinical study including a total of 1,074 patients (1,012 in the original study and an additional 62 patients to demonstrate applicability for the Omikron variant) confirms the results of the interim report on the performance and value of the CoV50 test.

As shown in this publication, also on the basis of model calculations, the application of the proteome test could not only help to massively reduce COVID-19-associated mortality, but would also result in considerable cost savings for the health care system.

Clinical proteomic analysis is an innovative technology enabling detection of diseases at the molecular level at a very early point in time. Non-communicable diseases generally develop at the molecular, the proteome level. Currently these diseases are detected when organ function is reduced, generally too late for efficient therapeutic intervention. Late intervention results in chronić disease, reduced quality of life and life expectancy. The clinical proteome analysis focuses on the molecular – proteomic – reaction of the body to the infectious agent, in this case including SARS-CoV-2. Therefore and as also shown in the published study, the prediction of severe COVID-19 course is generally independent of the COVID strain and is also predictive in new strains, such as the Delta and Omicron variants.