UK-based genetics testing company DnaNudge has received Ghana’s Food and Drugs Authority (FDA) approval to deploy its four-in-one, rapid point-of-care respiratory viruses test in the West African nation.

DnaNudge, a spin-out of Imperial College London, designed the multiplex test to accurately detect SARS CoV-2, Flu A, Flu B and Respiratory Syncytial Virus (RSV).

It is a lab-free, multiplexed sample-to-result test that offers the capabilities of lab-based PCR diagnostics, on a single Quad testing cartridge.

The Quad cartridge test is designed to detect SARS CoV-2, the virus that causes Covid-19, two important types of influenza viruses and RSV, and provide test results within one hour.

Unlike other nucleic acid point-of-care tests, which are based on isothermal amplification methods, its test leverages gold-standard RT-PCR, said DnaNudge.

Also, the regulatory approval facilitates the widespread community use of its diagnostic test device in Ghana and throughout Africa, said the genetic testing provider.

University of Ghana clinical virologist Alexander Martin-Odoom said: “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.”

DnaNudge’s Lab-in-Cartridge system requires test samples can be collected through nasopharyngeal, nasal or nose and throat combined swabs.

The sample swab is placed into a disposable cartridge and is inserted into the portable NudgeBox for analysis and reverse transcribing to DNA, to get sample-to-result within an hour.

Ghana FDA has validated DnaNudge’s NudgeBox platform, including the NudgeBox portable analyser and new multiplex Quad cartridge, at the Quadushah Medical Diagnostic Centre.

Last month, DnaNudge signed a commercialisation deal with NantNudge, a new entity created to drive genomics and AI point-of-decision technology.

Under the license agreement, NantNudge can manufacture, sell and supply DnaNudge’s medical and consumer testing technologies and services in certain territories, including Africa.

Building on the licence agreement, NantNudge will now roll out DnaNudge’s point-of-care respiratory test across Africa, starting with Ghana.

Furthermore, NantNudge and DnaNudge are executing an active programme to co-develop further rapid, out-of-lab testing panels, to address critical global health challenges.

DnaNudge co-founder Chris Toumazou said: “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.”

Imperial College London infectious diseases professor Graham Cooke 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.”