CE marking has been announced for a half-hour infant hearing loss test to screen babies for the gene mutation that brings lifelong deafness when these susceptible patients are given certain antibiotics.
Typically, current testing for the risk of hearing loss associated with gentamicin through mutation in the MT-RNR1 gene brings results in three to five days, too long a wait when national guidelines in the UK advise infants with suspected infection being treated with antibiotics within one hour of arriving in a neonatal intensive care unit. By the time the test results come back, the infant may have been condemned to deafness.
This new critical care test, developed by a molecular diagnostics firm based in Manchester, UK—Genedrive—takes under 30 minutes to deliver a diagnosis. With its CE mark obtained, it can now pass to the phase of implementation evaluation by the company's NHS partners in Manchester and Liverpool. The CE marking for the "Genedrive MT-RNR1 ID’ kit means its developers affirm that it meets the health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). It also opens up non-EEA markets that accept these standards, and to which Genedrive indicated that they will seek entry.
Announcing the CE marking this week, Genedrive, which has shares floated on the Alternative Investment Market, claimed the RNR1 test was believed to be the first example of a commercial genetic screening test designed for use in an infant emergency care environment.
“We are very pleased to have achieved this important milestone, pioneering the availability of the first genetic acute care test for infants,” said the firm's CEO David Budd.