Obtaining the CE Marking Certification, which allows commercialization of medical devices requires demands for the completion of rigorous test validation. Thereafter is the submission of an application to the European Union. Of the many companies, which have obtained CE Mark Certification is NuGenerex Diagnostics LLC, a subsidiary of Generex Biotechnology Corporation (OTCMKTS:GNBT).
The integrated healthcare holding company says that it has received the CE Mark for its Express II Syphilis Treponemal Assay. The rapid point-of-care diagnostic assay detects syphilis antibodies in primary and secondary syphilis. Its accuracy is comparable to the standards of laboratory assays and whose specificities are more often than not above 99%. Besides, it is easy to administer in privacy.
CE Marking signifies high standards of safety, health, and environmental protection
There is an alarming rate of increase in the epidemic of syphilis and new infections. The disease has reemerged as a primary sexually transmitted disease with the high-risk groups being at biggest victims. Even the pregnant women have not spared either and particularly those with a concomitant rise of congenital syphilis in newborns. Sadly, projections indicate that infections will rise by 20% by 2022.
However, there is hope with CE Mark Certification. It implies that any product sold in the EEA is safe and healthy for consumption. The Marking ensures free movement of products. As it is now, NuGenerex Diagnostics is on point in the provision of the necessary efforts. It is not only a fully qualified diagnostic test developer but also a manufacturer under FDA Good Manufacturing Procedures (GMP).
The Chief Medical and Scientific Officer of Generex, Dr. Jason B. Terrell says, “The filing for CE Marking represents a critical advancement in commercialization, and we are now one step closer to delivering this much-needed test to millions of patients across the world.”
Generex has reorganized its portfolio of immuno-oncology assets
For the last two years, the company has been working on the reorganization of its portfolio. This was in line with its vision of being the healthcare holding company that adds significant value to its shareholders. It has settled on strategic businesses partnerships with various institutions such as management services organization (MSO). The aim is to offer optimal care while building ongoing relationships with patients.