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Genedrive Receives CE Mark for Hearing Loss Assay

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. 

Babies with the MT-RNR1 gene mutation are susceptible to hearing loss if they are given the antibiotic gentamicin, but current genetic tests that check risk of hearing loss typically take three to five business days to obtain results. The Genedrive test allows patients to be screened upon admission to the critical care setting in less than 30 minutes. 

Genedrive developed the test in partnership with researchers at the Manchester Center for Genomic Medicine. 

The UK's National Health Service is planning to implement the test across Manchester and Liverpool for the next six to eight months to evaluate how it can be successfully implemented in an NHS environment, according to William Newman, clinical head of Division in Genomic Medicine Manchester University NHS Foundation Trust. 

Last year, Genedrive received £550,000 ($725,730) from the UK National Institute for Health Research to develop the point-of-care test.