From March 15, 2024, and for a period of 5 years, BioMAdvanced Diagnostics is authorized to export RNA extracted from human blood to some partner laboratories in Europe as part of the development of its first in vitro diagnostics test (targeting patients with a kidney transplant).
For memory, this first product aims at assessing with a very high degree of confidence the absence of subclinical rejection in kidney transplant patients.
AN AUTHORIZATION ESSENTIAL TO OUR DEVELOPMENT
Our product development process includes extensive testing involving selected partner laboratories located in Norway, Spain, Italy, and the Netherlands.
We are planning to send RNA samples alongside our kits to those laboratories so that they can test our product. The results of these analyses will aim at validating the reproducibility and suitability for use in very different settings by independent teams.
A LITTLE BIT OF BACKGROUND
Concerning elements from the human body (organs, tissues, cells, components, and derivatives), French legislation provides for cross-border movement restrictions between France and another member state of the European Union.
The import and/or export of elements from the human body is only possible for specific purposes, including scientific purposes, and subject to authorization from the French minister responsible for research.
Among other things, the legislation ensures that the consent of donors, free donation, and anonymity are preserved.