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Home » Business, Policy & Funding » Regulatory News & FDA Approvals » Genedrive Receives CE Mark for Hearing Loss Assay

Genedrive Receives CE Mark for Hearing Loss Assay

Nov 21, 2019
|
staff reporter

NEW YORK – Molecular diagnostics company Genedrive announced Monday that its antibiotic-induced hearing loss test, the Genedrive MT-RNR1 ID kit, obtained CE marking.

The test will be used to screen babies for a genetic mutation that can cause lifelong deafness when they are given certain antibiotics. The company said in a statement the RNR1 test is believed to be the first commercial genetic screening test designed for use in an infant emergency care environment. 

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