The Branford, Connecticut-based startup plans to seek US Food and Drug Administration clearance for and launch its instrument and first assays in 2021.
The Dublin, Ireland-based company plans to launch its new instrument by the end of 2021 and will pursue CLIA waiver in the US.
The company received support from a Johns Hopkins University center focused on point-of-care device development for sexually transmitted infections.
The test for P. vivax-associated malaria was developed with support from FIND and will be distributed by Human Diagnostics Worldwide.
The researchers said that affordable tests that can differentiate malaria from similar diseases is vital for administering the most targeted treatment for patients.
The researchers built a combination nucleic acid-antibody test for the disease using an approach they said could be generally useful for rapid test development.
A new assay uses digital loop-mediated isothermal amplification (dLAMP) to perform phenotypic antibacterial susceptibility testing in 30 minutes.
The test leverages loop mediated isothermal amplification technology and enables the rapid detection of Neisseria meningitidis directly from cerebrospinal fluid samples.
The studies provide further support for Meridian's Illumigene Malaria as a tool for routine screening of travelers in non-endemic areas of the world.
The device, which will be tested in collaboration with a Panamanian research institute, will run 40-minute tests without the need for electricity.