DnaNudge has obtained approval from the Food and Drugs Authority (FDA) in Ghana for the deployment of a multiplex polymerase chain reaction (PCR) platform to diagnose four-in-one respiratory pathogens.
The four-in-one respiratory virus test will be deployed clinically, both inside and outside labs, in the West African country.
The rapid point-of-care test holds the potential to precisely identify influenzas A and B, respiratory syncytial virus (RSV) and SARS CoV-2 on a single ‘Quad’ testing cartridge. It can identify two main influenza and RSV types, as well as SARS-CoV-2 in about an hour.
Designed to provide lab-based PCR diagnostic capabilities, the lab-free multiplexed sample-to-result test utilises gold-standard reverse transcription (RT) PCR.
DnaNudge's testing platform consists of the NudgeBox portable analyser and a new multiplex Quad cartridge.
Both have been validated by the Ghana FDA for clinical application in the country at the Quadushah Medical Diagnostic Centre.
University of Ghana clinical virologist Dr 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 lifesaving, ultra-fast diagnostic tests for the population.”
Last month, DnaNudge and NantNudge signed a commercialisation agreement for manufacturing, selling, and supplying the former’s medical and consumer testing technologies and services in crucial territories, including Africa.
NantNudge will now spearhead the introduction of DnaNudge's point-of-care technology throughout Africa, starting in Ghana.
This initiative will run alongside an active programme to co-develop additional rapid, out-of-lab testing panels with DnaNudge to tackle pressing global health issues.
DnaNudge is presently conducting a clinical trial in Africa to validate a new test designed to transform the treatment of diabetic foot infection.
The test is also intended for use in other wound care applications.
