In October, Biohope reached the CE Mark for the IMMUNOBIOGRAM®, a first in class IVD test for the in-vitro measurement of metabolic activity of patient’s immune cells as response to individual immunosuppressive drugs.
Therefore, for patients with renal transplant, IMMUNOBIOGRAM® provides an information of the patient in vitro response to each immunosuppressive drug that will help physicians to personalize the immunosuppressant regimen with the aim to improve the clinical outcomes.
The CE Mark is supported by a complete Technical File that complies with all the IVD regulatory requirements laid down in the EUROPEAN UNION, actual Directive 98/79/EC, and already is close to fulfill with future regulatory requirements in Europe, IVD-R.
CE Mark allows Biohope to commercialize in Europe the IMMUNOBIOGRAM®, and it represents a key element to obtain further regulatory approvals in many other countries that highly value the CE Mark.
By the CE mark BIOHOPE ensures and declares about the following key aspects:
- BIOHOPE SCIENTIFIC SOLUTIONS FOR HUMAN HEALTH S.L., (TIN: B87290060) , in relation to the In Vitro Diagnostic product named IMMUNOBIOGRAM (IMBG)®, has successfully complied with all the requirements established by the EUROPEAN UNION in the Directive 98/79/CE, and by the ISO 13485 2016, ISO 14971 2019, and ISO 23640, about IVD products.
- BIOHOPE has successfully implemented the ISO 13485:2016 (MD 711005) quality system, with the following scope: “Design and manufacturing of in vitro diagnostic immunoassays for the determination of individualized patient response pattern to immunosuppressive medication”. This quality system has been audited and certified by BSI Group The Netherlands B.V.
- The IMMUNOBIOGRAM (IMBG)®, measures in vitro the metabolic activity and response of activated peripheral blood immune cells (PBMCs), when exposed to individual immunosuppressive drugs. This test gives the physician an individualized pharmacodynamic information by immunosuppressant, in patients with renal transplant treated with immunosuppressant therapy in the maintenance phase.
- The IMBG has successfully passed all the tests laid down by the regulations above mentioned, therefore, according to the Annex III of the DIRECTIVE 98/79/EC, it can fully incorporate the CE MARK. Consequently, the IMBG can be sold in all the European Territory, while providing all the legal and safety requirements.