FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Omega Diagnostics’ HIV Monitoring Test Receives CE Mark

March 20, 2019
A A

Omega Diagnostics’ Visitect CD4 advanced disease test for HIV has been passed the CE Mark, a test used to monitor patients with HIV.

The advanced disease test uses a cut-off level at which patients’ immune systems are so weakened by HIV that they are vulnerable to infection by other diseases, enabling it to identify patients with advanced HIV.

The company said there exists an unmet need in low and middle-income countries for a test that can identify patients living with advanced HIV.

View today's stories