The UK National Institute for Health Research’s Invention for Innovation program has awarded molecular diagnostics developer Genedrive £550,000 (about $725,000) as part of a larger multi-partner grant award to develop and implement a point-of-care pharmacogenetic test to avoid antibiotic-related hearing loss in newborn children.

The grant will go toward funding a Genedrive targeted test designed to generate genetic results within an hour, allowing alternative antibiotics to be used and thus avoiding the potential life changing adverse reaction to gentamicin.

In the UK, according to Genedrive, approximately 90,000 babies per year are treated with gentamicin, exposure to which results in irreversible hearing loss in some individuals with an identified genetic predisposition. While antibiotic treatment should begin within the first hour after admission, current lab-based genetic tests are not able to return actionable results within that timeframe, according to the company.

The project is expected to commence immediately, with an expected development phase of one year followed by a trial implementation phase in selected UK National Health Service (NHS) hospitals in the second year.

At that point, the company said, it plans to target the release of a Genedrive test within the NHS and more broadly.

Genedrive is a patented small polymerase chain reaction (PCR) platform designed to enable rapid nucleic acid amplification and detection from various sample types including plasma, sputum, and buccal swabs. The test is designed as a rapid and low cost molecular diagnostics platform for identifying and selecting treatments for infectious diseases, human genotyping, animal health, pathogen identification, and other applications.

Results are available within 50 minutes, Genedrive says.

“The NHS is a huge market place and, if adopted, this would be the first placement of Genedrive in a developed-world healthcare setting,” Genedrive CEO David Budd said in a statement. “The project is an exciting opportunity to expand the markets in which Genedrive is used.” 

Genedrive said the project represents an important landmark for its namesake platform as it is the first potential application outside of the low and middle-income markets targeted with current hepatitis C virus (HCV) and mycobacterium tuberculosis (mTB) programs.

The company said it expects to account for its £550,000 share of the project funding as income, which will be matched to costs incurred over the two-year project. The exact amount and timing of the income is expected to be finalized shortly as part of a collaboration agreement with Genedrive’s consortium partners.

That consortium will be led by William Newman, Ph.D., Professor of Translational Genomic Medicine at the University of Manchester.

“We look forward to working with Genedrive and our colleagues in Manchester and Liverpool to assess the impact of rapid genetic testing as a method of avoiding irreversible hearing loss in babies treated with antibiotics,” stated Dr. Newman, who is also a consultant at Manchester University NHS Foundation Trust.

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