Generex Subsidiary NuGenerex Diagnostics Announces CE-Mark Certification for its Rapid Point-of-Care Express II Syphilis Treponemal Assay
GlobeNewswire•January 24, 2019
-- Rapid point-of-care syphilis assay
-- Cleared for sale in the European Union
-- Addressing the emerging global syphilis resurgence
MIRAMAR, FL, Jan. 24, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- NuGenerex Diagnostics LLC, (www.nugenerexdiagnostics.com) a subsidiary of Generex Biotechnology Corporation (www.generex.com) (GNBT), announced today receipt of the CE Marking Certification for its rapid point-of-care Express II Syphilis Treponemal Assay.
Commercialization of medical devices in the European Union requires meeting the regulatory guidelines of the European Medical Devices Directive (MDD) and fulfillment of those requirements allows a device to carry the “CE-Mark” as verification of its diagnostic authenticity. After completing rigorous test validation and submission of an application to the European Union, NuGenerex Diagnostics is pleased to announce that the CE Mark Certification for its The Express II Syphilis Treponemal Assay has been granted.
The Express II Syphilis Treponemal Assay is a rapid point-of-care diagnostic assay for the detection of syphilis antibodies in primary and secondary syphilis and is based upon NuGenerex Diagnostics’ innovative patent pending point-of-care diagnostic platform, the Express II. The accuracy of the Express II Syphilis Treponemal Assay is equal to or better than standard laboratory assays for syphilis antibodies with sensitivities and specificities of over 99%.
The Express II platform is designed to be used in a broad range of clinical and laboratory medical settings and for direct use by consumers in the home. It is simple to use, with fewer steps of operation than other rapid point-of-care tests. A single drop of blood taken by a simple finger stick is added directly to the device and the assay is activated by placing a pod of buffer solution onto the device. Results can be read in as early as 5 minutes, and no longer than 30 minutes. These simple operations allow the device to be used in all medical settings which include clinics, hospitals, laboratories, and remote field facilities. Importantly, in some countries, Express II devices can be marketed for individual in-home use directly by consumers who can conduct tests by themselves in privacy, without special training or the aid of a separate individual.
There is currently a worldwide epidemic of syphilis and new infections are increasing at an alarming rate. This disease, once on the decline, has reemerged as a major sexually transmitted disease with most new cases occurring in high risk groups of gay or bisexual men. There is also a significant rise of syphilis in pregnant women, with a concomitant rise of congenital syphilis in newborns. The syphilis testing market currently makes up approximately 12-14% of the global sexually-transmitted disease diagnostic market. However, the syphilis infection rate is rapidly trending upward and these infections are projected to rise to 20% of the sexually-transmitted disease market by 2022.
With the receipt of the CE Mark Certification for its rapid point-of-care Express II Syphilis Treponemal Assay NuGenerex Diagnostics is well situated to enter into this growing syphilis testing market and will now pursue marketing efforts in Europe and, in parallel, begin plans for the filing of a 510k application with the United States FDA for marketing clearance in the United States. To this end, NuGenerex Diagnostics is fully qualified as a diagnostic test developer and manufacturer under FDA Good Manufacturing Procedures (GMP) and is certified by the International Standards Organization for the manufacture of medical devices under ISO 13485-2016 regulations.
Harold G. Haines Ph.D., President of NuGenerex Diagnostics, stated: “At NuGenerex Diagnostics we believe that the commercialization of the Express II Syphilis Treponemal Assay will provide a medically necessary and highly accurate test, for use by both medical professionals and individual consumers, and will significantly augment the ongoing effort to treat and control the rising worldwide epidemic of syphilis, a dangerous disease affecting the health and quality of life of millions of people. Syphilis is a curable disease if diagnosed accurately and treated appropriately. A major key to the effective treatment and elimination of syphilis is rapid and accurate diagnosis as made available by the Express II Syphilis Treponemal Assay. In this respect we are proud to be part of the international medical community’s effort to control the spread of syphilis and look forward to working with medical professionals and affected individuals worldwide in this ongoing effort.”
Dr. Jason Terrell M.D., Generex Chief Medical and Scientific Officer, stated, “I’d like to extend my praise and appreciation to Dr. Haines and the NuGenerex Diagnostic team for achieving this milestone. Dr. Haines has created a culture of excitement, innovation, determination, and commitment to success. Under Dr. Haines’ leadership, I expect NuGenerex Diagnostics will continue to expand the product pipeline and deliver multiple high-impact products to patients worldwide.”
GlobeNewswire•January 24, 2019
-- Rapid point-of-care syphilis assay
-- Cleared for sale in the European Union
-- Addressing the emerging global syphilis resurgence
MIRAMAR, FL, Jan. 24, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- NuGenerex Diagnostics LLC, (www.nugenerexdiagnostics.com) a subsidiary of Generex Biotechnology Corporation (www.generex.com) (GNBT), announced today receipt of the CE Marking Certification for its rapid point-of-care Express II Syphilis Treponemal Assay.
Commercialization of medical devices in the European Union requires meeting the regulatory guidelines of the European Medical Devices Directive (MDD) and fulfillment of those requirements allows a device to carry the “CE-Mark” as verification of its diagnostic authenticity. After completing rigorous test validation and submission of an application to the European Union, NuGenerex Diagnostics is pleased to announce that the CE Mark Certification for its The Express II Syphilis Treponemal Assay has been granted.
The Express II Syphilis Treponemal Assay is a rapid point-of-care diagnostic assay for the detection of syphilis antibodies in primary and secondary syphilis and is based upon NuGenerex Diagnostics’ innovative patent pending point-of-care diagnostic platform, the Express II. The accuracy of the Express II Syphilis Treponemal Assay is equal to or better than standard laboratory assays for syphilis antibodies with sensitivities and specificities of over 99%.
The Express II platform is designed to be used in a broad range of clinical and laboratory medical settings and for direct use by consumers in the home. It is simple to use, with fewer steps of operation than other rapid point-of-care tests. A single drop of blood taken by a simple finger stick is added directly to the device and the assay is activated by placing a pod of buffer solution onto the device. Results can be read in as early as 5 minutes, and no longer than 30 minutes. These simple operations allow the device to be used in all medical settings which include clinics, hospitals, laboratories, and remote field facilities. Importantly, in some countries, Express II devices can be marketed for individual in-home use directly by consumers who can conduct tests by themselves in privacy, without special training or the aid of a separate individual.
There is currently a worldwide epidemic of syphilis and new infections are increasing at an alarming rate. This disease, once on the decline, has reemerged as a major sexually transmitted disease with most new cases occurring in high risk groups of gay or bisexual men. There is also a significant rise of syphilis in pregnant women, with a concomitant rise of congenital syphilis in newborns. The syphilis testing market currently makes up approximately 12-14% of the global sexually-transmitted disease diagnostic market. However, the syphilis infection rate is rapidly trending upward and these infections are projected to rise to 20% of the sexually-transmitted disease market by 2022.
With the receipt of the CE Mark Certification for its rapid point-of-care Express II Syphilis Treponemal Assay NuGenerex Diagnostics is well situated to enter into this growing syphilis testing market and will now pursue marketing efforts in Europe and, in parallel, begin plans for the filing of a 510k application with the United States FDA for marketing clearance in the United States. To this end, NuGenerex Diagnostics is fully qualified as a diagnostic test developer and manufacturer under FDA Good Manufacturing Procedures (GMP) and is certified by the International Standards Organization for the manufacture of medical devices under ISO 13485-2016 regulations.
Harold G. Haines Ph.D., President of NuGenerex Diagnostics, stated: “At NuGenerex Diagnostics we believe that the commercialization of the Express II Syphilis Treponemal Assay will provide a medically necessary and highly accurate test, for use by both medical professionals and individual consumers, and will significantly augment the ongoing effort to treat and control the rising worldwide epidemic of syphilis, a dangerous disease affecting the health and quality of life of millions of people. Syphilis is a curable disease if diagnosed accurately and treated appropriately. A major key to the effective treatment and elimination of syphilis is rapid and accurate diagnosis as made available by the Express II Syphilis Treponemal Assay. In this respect we are proud to be part of the international medical community’s effort to control the spread of syphilis and look forward to working with medical professionals and affected individuals worldwide in this ongoing effort.”
Dr. Jason Terrell M.D., Generex Chief Medical and Scientific Officer, stated, “I’d like to extend my praise and appreciation to Dr. Haines and the NuGenerex Diagnostic team for achieving this milestone. Dr. Haines has created a culture of excitement, innovation, determination, and commitment to success. Under Dr. Haines’ leadership, I expect NuGenerex Diagnostics will continue to expand the product pipeline and deliver multiple high-impact products to patients worldwide.”
1
