US regulator awards genedrive Breakthrough Device Designation

Manchester molecular testing business, genedrive, has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its Genedrive MT-RNR1 ID Kit.

The kit is the world’s first rapid point-of-care test to screen infants in an urgent care setting for a genetic variant that can cause life-long hearing loss when carriers of the variant are given certain antibiotics.

Those infants identified by the kit as carrying the variant can then be given alternative antibiotics.

It has the potential to save thousands of children from lifelong hearing loss, while providing a net positive financial outcome case to healthcare systems.

The Breakthrough Devices Programme is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorisation. Breakthrough Devices must meet the FDA’s standards for device safety and effectiveness in order to be authorised for marketing.

The programme offers manufacturers an opportunity to interact with FDA experts through several different programme options to efficiently address topics as they arise during the premarket review phase.

This interaction can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritised review of their submission

In 2021, 3.7 million babies were born in the USA, with 10.5% born prematurely. It was estimated that malpractice litigation settlements in cases related to deafness caused by the use of aminoglycosides average 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.

Extrapolating from UK figures, the company estimates that approximately 1,000 babies per annum in US Neonatal Intensive Care Units (NICU) are at risk of aminoglycoside-induced hearing loss.

Genedrive intends to pursue the FDA De Novo regulatory pathway for entry into the US market. The FDA De Novo pathway provides a vehicle for establishing new predicate devices that can reflect modern standards for performance and safety and can serve as a basis for future clearances.

De Novo classification is a risk-based classification process used when there is a lack of a predicate device already cleared by the FDA.

James Cheek, genedrive CEO, welcomed receipt of FDA designation of the MT-RNR1 point of care pharmacogenetic test and corresponding recognition of the potential benefits to US patients.

He said: “The US is an attractive market for this unique test given the potential to save hundreds of individuals from lifelong deafness and reduce litigation costs relating to the unwanted side effects from antibiotic use on those carrying the gene variant, and given its size, birth rates, use of diagnostic testing and reimbursement structure.

“The FDA Breakthrough Device Designation process will be invaluable in mitigating study design risks associated with bringing a novel test such as this to the US market where no predicate device exists with which to align study designs to.

“Together, with our in-place partnership with a multi-state physician-led clinical partner with neonatal services expertise covering the majority of US states, we look forward to affordable, collaborative and timely progress through the FDA De novo process.”

In March this year, when it announced its interim results, genedrive revealed it only had a cash runway through to May and needed to find additional funding.

In May the company unveiled a series of actions to bolster its finances which could raise just more than £8m.

The aim was to raise £3.5m in a retail offer via the Retail Capital Markets ‘REX’ portal, £2.3m through a non-pre-emptive conditional placing, £2.1m from an open offer and £170,000 in a non-pre-emptive firm placing. Shortly after it said it had successfully raised £2.1m.

Then, almost three weeks later, it said it had conditionally raised £2.03m through the open offer and a further circa £1.89m through the REX offer.