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Biocartis Gets CE Mark for SARS-CoV-2 RT-PCR Test

NEW YORK – Biocartis said on Tuesday that it has obtained the CE mark for its Idylla SARS-CoV-2 assay.

The test is a fully automated RT-PCR assay for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal swabs from patients suspected to have COVID-19. The test produces results in 90 minutes using the company's single-use cartridges and Idylla instrument.

"This is our second CE-marked IVD infectious diseases test offered this year on Idylla after the SeptiCyte Rapid [test], which was released in Europe as a CE-IVD test [in] early October," Herman Verrelst, CEO of Biocartis, said in a statement. "The Idylla SARS-CoV-2 Test is now available for clinical use across Europe to help healthcare providers manage this pandemic through rapid and easy testing of individuals with flu-like symptoms." 

The firm said that the Idylla SARS-CoV-2 test will be available across Europe. For example, it will be used by Health Services Laboratories (HSL), a partnership between The Doctors Laboratory, Royal Free London NHS Foundation Trust, and the University College London Hospitals NHS Foundation Trust. HSL will serve as one of the initial adopters of the test. 

"We have been pleased to add Biocartis' Idylla platform to a number of other rapid diagnostic systems, with which we have undertaken performance evaluations prior to introduction in routine clinical practice," Michael Gandy, head of R&D at HSL, said in a statement. "We feel this is an excellent candidate assay for provision of rapid testing in the acute setting."

Biocartis submitted the test to the US Food and Drug Administration for Emergency Use Authorization back in August and is waiting for a decision.

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