Takara Bio Europe Gains CE-IVD Mark for COVID-19 Diagnostic Kit

Takara Bio Europe has received a CE mark certification for its SARS-CoV-2 Direct polymerase chain-reaction (PCR) diagnostic detection kit and has begun marketing the product in Europe. 

The Takara test is an in vitro diagnostic assay for the qualitative detection of the coronavirus that causes COVID-19 in patients suspected of having the disease. It can detect infections from nasopharyngeal or nasal swab samples, or from saliva samples.

Takara Bio Europe is a subsidiary of Japan-based Takara Bio. The in vitro diagnostic kit was approved in Japan last year.