Yesterday, the Logix Smart™ Coronavirus COVID-19 Test developed by Co-Diagnostics received CE marking as the virus nears “pandemic” status. CE-IVD marking indicates that the In Vitro Diagnostic (IVD) conforms with relevant EU directives regarding the health and safety of the product.
The World Health Organisation (WHO) has stated that it is “too early” to dub the virus as a pandemic but has warned that the world must prepare for the possibility.
The diagnostic test uses a reverse-transcriptase quantitative PCR assay with a proprietary Co-Primer technology that Co-diagnostics claim could reduce the likelihood of false-positive results by increasing its specificity. Now, the test is available for sale as an in vitro diagnostic in markets that accept the CE marking as regulatory approval.
This comes after the Foundation for Innovative New Diagnostics (FIND) and the WHO launched a collaboration to perform a standardised evaluation of the available molecular tests to help “inform public health policy, surveillance programs and clinical management of patients”. FIND issued an expression of interest (EOI) last week for developers of tests for SARS-COV-2 who are interested in getting their assays evaluated for submission, which closes tomorrow.
The results of the EOI will be shared with the global health community to inform of the diagnostic testing approaches and all tests submitted will be included in the SARS-CoV-2 diagnostics pipeline tracker on FIND’s website.