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Takara Bio Gets CE-IVD Mark for SARS-CoV-2 Test

NEW YORK — Takara Bio Europe said on Tuesday that it has received CE-IVD marking for an RT-qPCR-based test for the detection of SARS-CoV-2.

The Takara SARS-CoV-2 Direct PCR detection kit is designed to detect regions of the SARS-CoV-2 nucleocapsid genes in nasopharyngeal or nasal swab samples, as well as crude saliva samples. It does not require RNA extraction and provides results within 60 minutes, the company said.

The test was approved in Japan last year, Takara Bio Europe said.

Takara Bio Europe is a French subsidiary of Japan's Takara Bio.