Bioprognos Presents a Revolutionary Non-invasive Test for the Diagnosis of Breast Cancer
It is expected that the new test will save up to 90% of unnecessary breast biopsies that are usually done to confirm malignancy in suspicious findings in diagnostic imaging procedures (such as all classified as BI-RADS 3 and BI-RADS 4).
The study, developed in the HOSPITAL JUAN RAMÓN JIMÉNEZ of Huelva (Spain), was coordinated by the head of Oncology of the HOSPITAL JUAN RAMÓN JIMÉNEZ, Juan Bayo MD, PhD, and carried out together with Jacobo Díaz MD, PhD (professor at MIGUEL ÁNGEL CASTAÑO CENTER and HOSPITAL DE LA CRUZ ROJA of Ceuta), as well as with Francisco Navarro MD, PhD (Cell Biology Doctor at the UNIVERSITY OF HUELVA). The study also included other professionals from the JUAN RAMÓN JIMÉNEZ HOSPITAL and from the FABIS FOUNDATION.
The advance presented by this group of researchers to the scientific community is the creation of a new probabilistic model that predicts the risk of breast cancer through a simple blood test. In this way, the sensitivity and specificity of all current analytical tests for the diagnosis of these patients will be improved, advancing even more in the early diagnosis, even before what is known as "Visibility Threshold" (see attached image). This will contribute to the improvement of its clinical evolution, resulting in a higher ratio of survival.
This research group has been working on the diagnosis of breast cancer disease for years, having identified an experimental algorithm based on a combination of different blood markers to diagnose it in early stages. These promising initial results were published in the scientific journal of Clinical Translational Oncology, of well-known reputation in the field of Oncology.
Besides, as part of the agreement, BIOPROGNOS will provide the necessary resources to continue the study, considerably expanding the number of patients through an international multicenter trial that will be developed in centers in Dominican Republic, France, Germany, Greece, India, Italy, Hungary, Poland, Romania, Russia, United Kingdom and United States.
Moreover, Bioprognos presented the results of this study in the past XV National Conference of Gynecology and Obstetrics organized by HM HOSPITALES Y GABINETE VELÁZQUEZ in Madrid (Spain), by Mª Dolores Ojeda MD, PhD (specialist in breast cancer with experience in comprehensive projects of the women health).
In the same way, this study was awarded by the first prize in the XXV scientific meeting of the ANDALUSIAN SOCIETY OF CLINICAL ANALYSIS (SANAC), held from the 8th to 10th of March in Huelva (Spain), and selected from a total of 202 scientific projects accepted in the congress.
Finally, after all CE Declarations of Conformity have been already achieved for European market, Bioprognos is working in a Dual 510(k) and CLIA Waiver by Application (Dual Submission) for in vitro diagnostic (IVD) to market all company's tests in the United States.
Anna Betoret (Chief Marketing Officer)