With this approval, the test can be marketed as an in-vitro diagnostic (IVD) in all countries that accept the CE-Mark.
Logix Smart ZDC Test performs a single-step reverse transcriptase real-time polymerase chain reaction (PCR) to identify and differentiate between Zika’s viral ribonucleic acid (RNA) and all four serotypes of dengue and chikungunya.
These viruses are spread via the Aedes mosquito and have similar symptoms, which lead to false diagnoses. The new test leverages the company’s CoPrimer technology to differentiate between the RNA of these viruses and identify and amplify their genomes.
The test uses serum samples to diagnose the infections, even when more than one target is present. When a patient’s result is positive for Zika, a cerebrospinal fluid (CSF) sample can also be collected to analyse for neurological infection.
Co-Diagnostics CEO Dwight Egan said: “Receiving the CE-Mark for our CoPrimer-based multiplex ZDC assay is the capstone of the design, development, validation, and regulatory approval process, which was completed from start to finish in under six months.
“This highly-specific diagnostic for three harmful diseases at once is possible due to our patented CoPrimer design platform, enabling a massive reduction in false positives, which is especially important but notoriously more difficult in multiplexed assays of related pathogens.”
More than half of the world’s population are at risk of infection from Zika, dengue and chikungunya. With rising infection rates for all three diseases, the company hopes that the Logix Smart ZDC Test will offer an affordable diagnostic option for early, accurate detection.