The Genedrive® MT-RNR1 kit (“MT-RNR1 ID kit”) is the world’s first rapid point-of-care test to screen infants in an urgent care setting for a genetic variant that will cause life-long hearing loss when carriers of the variant are given certain antibiotics. Those infants identified by the MT-RNR1 ID kit as carrying the variant can then be given alternative antibiotics. It has the potential to save thousands of children from lifelong hearing loss, whilst providing a net positive financial outcome case to healthcare systems.
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 over US$1.1 million 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 1000 babies per annum in US NICUs are at risk of aminoglycoside induced hearing loss.
The Genedrive® MT-RNR1 kit is CE-IVD certified, permitting commercialisation in those countries recognising CE certification, including the UK. As previously communicated, Genedrive intends to pursue the FDA De Novo regulatory pathway for subsequent entry to 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 predicate device already cleared by the FDA.
The Breakthrough Devices Program1 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 rigorous standards for device safety and effectiveness in order to be authorized for marketing.
Devices subject to premarket approval applications (PMAs), premarket notification [510(k)], or requests for De Novo classification request are eligible for Breakthrough Device designation if the device meets FDA criteria that it “provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions”, in addition to “there being No Approved or Cleared Alternatives” & “Device Availability being in the Best Interest of Patients”.
The Breakthrough Devices Program 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 prioritized review of their submission.
James Cheek, CEO of genedrive plc, said: “We are delighted to receive this FDA designation of our MT-RNR1 point of care pharmacogenetic test and recognition of the potential benefits to US patients. The US is an 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, 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 of majority of US states we look forward to affordable, collaborative and timely progress through the FDA De novo process”
1 https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program
