Achiko Obtains CE Mark, IVDR Registration for Aptamer-Based COVID-19 Antigen Test

Original from: 360DX

Achiko announced Tuesday that it has obtained the CE mark for its COVID-19 AptameX test and system, enabling its use in the European Union and other regions that accept the designation. 

The Zurich-based firm said it has also registered its AptameX test under the European Union's new Medical Device Research (MDR) and In Vitro Diagnostic Regulation (IVDR).

AptameX, a saliva-based rapid test, is read by an ultraviolet spectrophotometer and uses a DNA aptamer instead of an antibody to detect COVID-19. 

According to Achiko, DNA aptamers may have advantages over other enzyme-based approaches in terms of sensitivity, specificity, quality of production, cost, and test format.

The firm previously announced that its test demonstrated clinical sensitivity and specificity greater than 97 percent compared with PCR in an internal study.

Achiko has started production in Indonesia to meet local demand and is working with contract manufacturers in Taiwan to meet international demand. It anticipates that its tests will be widely available in the third quarter of this year.

Source: Achiko Obtains CE Mark, IVDR Registration for Aptamer-Based COVID-19 Antigen Test