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Shuwen Biotech Gets CE-IVD Mark for Molecular Coronavirus Test

NEW YORK — Shuwen Biotech said on Tuesday that it has received CE-IVD marking for its SARS-COV-2 RT-PCR Kit.

The test is designed to detect the SARS-CoV-2 ORF1ab and N genes in upper and lower respiratory specimens including nasal, nasopharyngeal and oropharyngeal swabs, Shuwen said. It has been validated on many widely available RT-PCR instruments including Thermo Fisher Scientific's Applied Biosystems 7500 and 7500 Fast systems, Roche's Cobas Z480 and LightCycler 480II, Bio-Rad Laboratories' CFX96, and Qiagen's Rotor-Gene Q.

Deqing, China-based Shuwen also said that it has received clearance from the Chinese government to export the test, which will be offered in foreign markets through the company's distribution network.

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