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(Sharecast News) - Near-patient molecular diagnostics company Genedrive has started engaging with the US Food and Drug Administration (FDA), it announced on Wednesday, to progress the regulatory approval of its 'MT-RNR1 ID Kit' into the United States.
The AIM-traded firm described the MT-RNR1 assay as "the world's first" rapid point-of-care test to screen infants in an urgent care setting for a genetic variant that would cause life-long hearing loss when carriers of the variant were given certain antibiotics.
It explained that those that carry the variant could then be given alternative treatments following detection of the variant by the test.
Genedrive said the test had the potential to save "thousands of children" from life-long hearing loss, while providing a net positive financial outcome to healthcare systems.
The company said it had submitted via the FDA's pre-submission (pre-sub) process, as there was no exact comparable test in the market already.
It said the pre-sub process would allow it to clarify its testing and validation approach, confirm the appropriate regulatory application pathway, and gain additional procedural feedback from the FDA with the aim of making the final submission process more efficient.
In 2021, 3.7 million babies were born in the US, with 10.5% born prematurely.
It was estimated that malpractice litigation settlements in cases related to deafness caused by the use of aminoglycosides averaged more than $1.1m per case, further adding to the positive health economic case of providing accurate and timely testing to reduce unwanted side effects of gentamicin usage.
"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," said chief executive officer David Budd.
"Either an FDA 510k clearance or the granting of a De Novo request is required to allow us to market this test in the US.
"Ultimately, we feel that the US market is potentially the most attractive market given its size, birth rates, use of diagnostic testing and reimbursement structure."
At 1045 BST, shares in Genedrive were up 35% at 14.85p.
Reporting by Josh White at Sharecast.com.
