Coronavirus company news summary – Cepheid receives Health Canada license for SARS-CoV-2, Flu A, Flu B and RSV combination test – SML Genetree receives FDA EUA for Ezplex SARS-CoV-2 G real-time PCR Kit

15 January 2021 (Last Updated January 15th, 2021 09:45)

Chembio Diagnostics has received CE certification for its DPP SARS-CoV-2 Antigen and IgM/IgG test systems. The company has also entered into a distribution agreement with Luas Diagnostics, to start selling the products immediately in the UK and Ireland.

Cepheid, a molecular diagnostics company, has been granted a Health Canada license for its Xpress SARS-CoV-2/Flu/RSV, a rapid molecular combination diagnostic test that can detect SARS-CoV-2, Flu A, Flu B, and RSV infections from a single sample. The test can deliver results in approximately 36 minutes and is now made available in Canada and can also be used in laboratories and at point of care facilities.

SML Genetree announced that it has been granted emergency use authorisation (EUA) by the US Food and Drug Administration (FDA) for its Ezplex SARS-CoV-2 G Kit, a real-time molecular diagnostic test that helps in detecting RNA from the SARS-CoV-2 virus from nasal and oral swabs, sputum specimens, as well as for use in pooled samples.