Genedrive PLC on Wednesday said it has entered into a clinical trial agreement to support clinical studies to progress the regulatory approval of its MT-RNR1 product.

The Manchester, England-based molecular diagnostics company said the deal is with a ‘leading multi-state physician organisation’ based in the US, but did not disclose its name.

The partnership will support clinical studies required for engagement with the US Food & Drug Administration.

The Genedrive MT-RNR1 ID Kit is a point-of-care genetic test to reduce the risk of antibiotic induced hearing loss. Following detection of the MT-RNR1 variant, an alternative antibiotic treatment can be prescribed. ‘It has the potential to save thousands of children from lifelong hearing loss, whilst providing a net positive financial outcome case to healthcare systems,’ Genedrive said.

Chief Executive Officer James Cheek said: ‘I am delighted with this agreement to progress our aim of introduction of our MT-RNR1 point of care pharmacogenetic test to the US. The US is a particularly attractive market for this unique test, given the potential to save hundreds of individuals from life-long deafness and reduce litigation costs relating to the unwanted side effects from antibiotic use on those carrying the gene variant. Additionally, the US market is potentially the most attractive market given its size, birth rates, use of diagnostic testing and reimbursement structure. As already announced, Genedrive will be seeking funding to progress the required clinical studies.’

Shares in Genedrive closed up 6.7% at 6.00 pence per share in London on Wednesday.

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