US-based firm Domus Diagnostics is ready to start clinical testing of its Covid-19 testing platform prototype.
The new SARS-COV-2 diagnostic test is designed to address the global need for accessible and rapid nucleic acid amplification tests (NAATs).
It is based on reverse transcription loop-mediated isothermal amplification (RT-LAMP) technology and aims to provide user-friendly, affordable and accurate infectious disease detection.
Domus will initially submit the test for approval through the World Health Organization (WHO). It will then be able to provide the test to governments and public health organisations in developing countries.
Upon completion of clinical trials, the company plans to also seek authorisation from the US Food and Drug Administration (FDA) for a multiplex test for Covid-19 and seasonal flu, as the Domus platform has the ability to detect multiple disease targets from a single sample.
To perform the test, individuals collect a nasal swab sample from each nostril and insert a collection chamber into a card. The results are obtained in 30 minutes.
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Domus Diagnostics president and CEO Paul Chapman said: “Inequities in vaccine and testing availability are one of the main reasons that we see significant disparities in outcomes between countries and between people of different racial and ethnic backgrounds.
“Domus’ vision is to provide a simple to use, highly accurate test that can be produced affordably at scale.
“Our talented team of scientists and engineers have developed a truly innovative NAAT testing solution that can finally address those testing gaps that have existed for decades between the developing world and the West.”
The company stated that the test can achieve accuracy equivalent to a PCR test and does not require instrumentation, electricity or cold chain logistics.