18.11.19
CE marking for antibiotic induced hearing loss test kit
A machine that tests infants for antibiotic induced hearing loss has received a European standard CE marking.
CE marking is a certification mark that shows that a product conforms with health, safety, and environmental protection standards for items sold within the European Economic Area. A product must have a CE marking before it can be sold in the EU.
Genedrive’s MT-RNR1 ID kit identifies the MT-RNR1 mutation in babies that can cause lifelong deafness if they are treated with the antibiotic gentamicin.
In the UK, 90,000 babies are treated with gentamicin each year. The antibiotic is used to treat such as infections as meningitis and sepsis – which are deadly if left untreated.
Genedrive chief executive David Budd said:
"We are very pleased to have achieved this important milestone, pioneering the availability of the first genetic acute care test for infants."
It is believed that the MT-RNR1 ID kit is the first example of a commercial genetic screening test designed for use in an infant emergency care environment.
Current hospital tests can take up to 5 days to identify the gene in babies, which doesn’t meet the one-hour requirement of an urgent care setting. Genedrive claims that their test can identify MT-RNR1 in under 30 minutes.
The shortening of time between testing and identifying the gene is significant because it allows the infant to be treated with an alternative antibiotic quicker, potentially saving their life.
The test is being praised for not only its accuracy but also its simplicity in operation, with claims that “any lab technician with basic training” can use it effectively.
William Newman, clinical head of division in Genomic Medicine Manchester University NHS Foundation Trust, said:
"We are planning to deploy use of the test across Manchester and Liverpool for the next six to eight months, to show how it can be successfully implemented in an NHS environment."