NEW YORK – Genedrive announced on Wednesday that it has received CE marking for the next generation of its Genedrive System gene amplification platform.
The system, targeted for professional use in emergency healthcare settings, was developed to support the commercial launch of the UK-based company's MT-RNR1 test for antibiotic-induced hearing loss in newborns.
The PCR-based test screens for a genetic mutation that can cause lifelong deafness if a baby is treated with the antibiotic gentamicin and received CE marking in 2019.
After a prospective trial led by Manchester University National Health Service Foundation Trust and the National Institute for Health Research Manchester Biomedical Research Centre evaluating the test and its potential implementation, the company incorporated "various product improvements and refinements," it said in a statement.
Those include informatic and ergonomic improvements, such as new wireless connectivity and printer options, it added.
The point-of-care molecular platform is ready for deployment at sites in the UK, to be followed by the European Union. The test, meantime, is being rolled out in partnership with Inspiration Healthcare as the UK and Ireland distributor, Genedrive said. The firm expects its first sales of the test this fall.
Genedrive CEO David Budd said in a statement that the first EU pilot site is already established and will serve as a reference site as the company targets select EU countries.