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After all CE Mark achievement, 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
BARCELONA, SPAIN, April 17, 2018 /24-7PressRelease/ -- BIOPROGNOS (www.bioprognos.com) has signed an agreement with the ANDALUSIAN HEALTH SERVICE and the FUNDACIÓN ANDALUZA BETURIA PARA LA INVESTIGACIÓN EN SALUD (FABIS FOUNDATION) to exclusively market the results of a study in the form of a diagnostic test for breast cancer. This is the fifth test developed by BIOPROGNOS which will be commercialized to help in breast cancer diagnosis, as well as the other 4 already existing tests for the diagnose cancer of lung, ovarian, prostate and cancer of unknown primary, all them based on a simple blood test.
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. 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).
Finally, 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.
BIOPROGNOS (www.bioprognos.com) is a biotech company located in Barcelona (SPAIN), created in January 2016 as a spin-off of the HCB. BIOPROGNOS is dedicated to the development of innovative, non-invasive, accurate, and cost-effective diagnostics solutions for the early detection of different types of cancer through a simple blood test.
As per our production roadmap, the tests for breast, lung, ovarian, prostate and unknown primary cancer, will be followed by others for liver, colorectal, head and neck and kidney cancers, all them in current development stage in collaboration with different national and international hospitals and research centres.
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