The company intends to seek the FDA authorisation for a multiplex test for Covid-19 and seasonal flu, post the completion of clinical trials.
US-based Domus Diagnostics has unveiled its reverse transcription loop-mediated isothermal amplification (RT-LAMP) test designed to detect Covid-19.
The company has announced that it will begin clinical testing of the new testing platform for the detection of SARS-COV-2.
According to Domus Diagnostics, the test will expand the access to rapid, Nucleic Acid Amplification Tests (NAAT) that avoids the need for an instrument of power.
With the capability to detect multiple targets from one sample, the company will target for the FDA authorisation for a multiplex test for Covid-19 and seasonal flu, post the completion of clinical trials.
To use the Domus test, a person has to take a nasal swab specimen from each nostril, insert a collecting chamber into a card, and the result will be available in 30 minutes without the need for instruments, electricity, or cold chain logistics.
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.
“This impact, we hope, will extend far beyond the current crisis and will enable better global preparedness for future pandemics.”
Domus Diagnostics is in talk with strategic partners and possible investors to grow the platform following clinical validation, following a $1.5m raising in a seed funding round.
Spun out of Duke University in early 2021, the company intends to expand its test menu to detect other viruses, bacteria or fungi.