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NuGenerex Gets CE Mark for Point-of-Care Syphilis Assay

NEW YORK (360Dx) — NuGenerex Diagnostics announced today that it has received CE marking for its rapid, point-of-care syphilis test called the Express II Syphilis TreponemalAssay.

The immunoassay is designed to detect syphilis treponemal antibodies in primary and secondary syphilis from a single drop of fingerstick blood. It runs on NuGenerex Diagnostics' Express II platform, which is designed for use in both medical and home settings, and provides results within 30 minutes with sensitivities and specificities of over 99 percent.According to NuGenerex Diagnostics, a drop of blood can be placed directly on the Express II system, and the assay is activated by placing a pod of buffer solution on the device.

The company noted that rates of syphilis are on the rise, and while the current syphilis testing market comprises about 12 to 14 percent of the total global sexually transmitted disease diagnostic space, by 2022, that figure is expected to reach 20 percent.

In general, point-of-care platforms for STDs are being more broadly adopted in the clinic.

Miramar, Florida-based NuGenerex Diagnostics — a subsidiary of Generex Biotechnology established through the late 2018 acquisition of Hema Diagnostic Systems — said that it will begin marketing the assay in Europe, as well as pursue 510(k) clearance from the US Food and Drug Administration.