DnaNudge Secures FDA approval to Deploy a Multiplex PCR Platform for Diagnosing Four-in-one Respiratory Pathogens in Ghana

Medical device approval for multiplex testing platform paves way for NantNudge to lead African roll-out of point-of-care technology

Medical and consumer genetics testing innovator and Imperial College London spin-out, DnaNudge, today announces that it has received approval from Ghana’s Food and Drugs Authority (FDA) to deliver its breakthrough four-in-one, respiratory viruses test for clinical deployment both inside and outside labs in the West African country.

The medical device approval paves the way for widespread community use in Ghana – and throughout Africa – of DnaNudge’s rapid point-of-care test, which can accurately detect SARS CoV-2, Flu A, Flu B and Respiratory Syncytial Virus (RSV) on a single ‘Quad’ testing cartridge.

The lab-free, highly multiplexed sample-to-result test offers the capabilities of lab-based PCR diagnostics. Unlike the majority of other nucleic acid point-of-care tests based on isothermal amplification methods, the DnaNudge technology uses gold standard RT-PCR. The Quad cartridge test can detect SARS CoV-2 (the virus that causes COVID-19), the two main types of influenza and RSV in around an hour, helping to ensure infection control in clinical settings and aiding clinicians and care teams in accurate differential diagnosis of these four common respiratory viruses, which can all present with very similar clinical signs and symptoms.

DnaNudge’s testing platform – including the NudgeBox portable analyser and new multiplex Quad cartridge – were validated by the Ghana FDA for clinical use in Ghana at the Quadushah Medical Diagnostic Centre, a secondary level diagnostic centre with a testing menu covering clinical and molecular assays in Tema, Ghana. The stringent performance assessment assay requirement was carried out by the Clinical Virologist (Alexander Martin-Odoom, PhD) on known positive and negative samples obtained from the Virology Department of the Noguchi Memorial Institute for Medical Research, the national research institute at the University of Ghana.

Dr Alexander Martin-Odoom, Clinical Virologist at University of Ghana commented: “The opportunity to implement such groundbreaking multiplex point-of-care testing technology in Ghana and – as the gateway to Africa – across the rest of the continent, is truly momentous. I am extremely pleased to be part of this collaboration, which will significantly advance infectious disease research and help realise life-saving, ultra-fast diagnostic tests for the population.”

Graham Cooke, Professor of Infectious Diseases at Imperial College London, who led the initial UK clinical validation of DnaNudge’s COVID-19 test (published in The Lancet Microbe in September 2020) said: “I’m excited to see this technology, whose development was greatly accelerated in response to COVID, start to become more widely available. I think it has the potential to transform a range of clinical pathways as well as provide important information for public and global health services.”

In November 2023, DnaNudge announced a landmark commercialisation deal with NantNudge LLC – a new entity created to drive transformative genomics and AI point-of-decision technology, founded by world-renowned surgeon, physician, scientist, inventor and philanthropist Dr Patrick Soon-Shiong. The license agreement allows NantNudge to manufacture, sell and supply DnaNudge’s medical and consumer testing technologies and services in key territories, including Africa.

NantNudge will now lead the roll-out of DnaNudge’s award-winning point-of-care technology across Africa, beginning in Ghana, in tandem with an active programme to co-develop with DnaNudge further rapid, out-of-lab testing panels to address critical global health challenges – from serious infectious diseases, precision medicine and oncology to TB, diabetic foot and urinary tract infections, sexually transmitted diseases and anti-microbial resistance tests. DnaNudge is currently underway with a key clinical trial in Africa to validate a new test aimed at revolutionising the treatment of Diabetic Foot Infection and targeted for use in other life and limb-saving wound care applications.

Commenting on the announcement of FDA approval in Ghana, Professor Chris Toumazou FREng FRS FMedSci, co-founder of DnaNudge and founder, Chief Scientist of the Institute of Biomedical Engineering at Imperial College London and Laureate of the UNESCO-Equatorial Guinea International Prize For Research in the Life Sciences said: “This milestone approval in Ghana marks the beginning of what we believe will be a seismic shift in the ubiquitous availability of advanced healthcare technology throughout Africa. In partnership with NantNudge, we are now embarking on the first phase of an extensive programme that will see the deployment of our highly multiplexed technology across villages, towns and cities in Africa, delivering equitable access to improved quality of care for communities and reducing costs, complexity and inefficiency for clinical teams and healthcare providers.”

DnaNudge’s NudgeBox platform technology delivers RT-PCR multiplex testing capabilities that are fast, affordable, and easy to implement in any setting, including non-clinical environments – meeting the global need for ubiquitous, reliable rapid testing at low cost and using minimal resources. DnaNudge’s Quad COVID/RSV/Flu test is the first sample-to-result RT-PCR test for the simultaneous qualitative detection and differentiation of genetic material from the SARS-CoV-2 virus, respiratory syncytial virus, and influenza A and influenza B viruses via a single swab – providing results on-the-spot, directly at the point of need.

DnaNudge’s Lab-in-Cartridge system works by placing a sample swab into a disposable cartridge that can extract RNA. The cartridge is then inserted into the portable NudgeBox for analysis and reverse transcribing to DNA, delivering sample-to-result in around an hour. Testing samples can be collected via nasopharyngeal, nasal only or combined nose and throat swabs. The unique lab-free nature of the DnaNudge system means that the test is ideal for use by healthcare professionals in any setting, including urban and rural environments.

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