Authentication company Dotz Nano Limited (ASX: DTZ) has obtained authorisation to use the CE Mark for its saliva-based SARS-CoV-2 virus detection technology. In an update to the ASX, Dotz said the CE Mark clears its saliva-based diagnostic Dotz Test Kits for sale in the European Union. It follows the company obtaining CE Mark authorisation in January for its nasopharyngeal swab-based Dotz Test Kits.
The Dotz Test Kits enable simultaneous testing of hundreds of virus samples with test results available within 17 minutes – determined on-site by the sample changing colour in the test tube. Dotz’s saliva-based test kits have demonstrated 100% true positive rates for viral loads of 1250 copies per mL when using 1 mL of input sample. The Dotz Test Kits also have 100% specificity, which means Dotz’s virus detection technology can detect SARS-CoV-2 without being triggered by other viruses.
While nasopharyngeal swab sampling is currently the standard testing method in most parts of the world, Dotz said its saliva-based test kits are less intrusive, simpler, and a more cost-efficient testing method.
Dotz has engaged US-based manufacturer Systaaq Diagnostic Products for its saliva-based Dotz Test Kit. The company is also progressing a clinical trial of its virus detection technology with Excelya in Greece as part of its FDA Emergency Use application.