NEW YORK – The National Institute for Health Research (NIHR) Manchester Biomedical Research Centre in the UK said last week that it has launched a clinical trial for a point-of-care PCR-based pharmacogenetic test to predict hearing loss from antibiotic treatment in newborns.
The test uses a cheek swab and delivers a result in less than 30 minutes. It is designed to detect a genetic variant that is present in 1 in 500 individuals. Individuals carrying the mutation suffer from severe hearing loss or deafness if they are treated with the antibiotic gentamicin.
The six-month trial will involve 1,000 newborns from two intensive care units, at St. Mary's Hospital Manchester University, NHS Foundation Trust and at Liverpool Women's Hospital, Liverpool Women's NHS Foundation Trust. The goal is to test all newborns within 10 minutes of admission.
Research to develop the test was funded with £900,000 ($1.2 million) from NIHR's i4i program and involved Genedrive, which provides the instrument on which the PCR test runs, as well as the Liverpool and Manchester neonatal intensive care units.
Last November, Genedrive obtained the CE mark for the test.
"Successful implementation would be a first in the integration of a rapid decision making, genetic-based diagnostic in the UK NHS," said Bill Newman, professor of translational genomic medicine at the University of Manchester and a consultant at Manchester University NHS Foundation Trust, in a statement