FDAnews
www.fdanews.com/articles/193494-genedrive-gets-ce-mark-for-baby-deafness-diagnostic

Genedrive Gets CE Mark for Baby Deafness Diagnostic

November 18, 2019

Molecular diagnostics firm Genedrive has received the CE Mark for its MT-RNR1 baby deafness genetic screening test, a diagnostic used in urgent care situations.

The testing kit is used in urgent care settings to identify babies with a genetic mutation that may cause them to go permanently deaf if they are given certain antibiotics. The current genetic tests usually take three to five days to produce results, the company said.

The diagnostic test can screen infants for the deafness-causing genetic mutation in under 30 minutes, and they can be prescribed different antibiotics that will not cause deafness.

View today's stories