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BD, CerTest Biotec Get CE Mark for SARS-CoV-2 Variant MDx

NEW YORK – Becton Dickinson and CerTest Biotec announced Friday that they have obtained the CE mark for a SARS-CoV-2 variant assay.

The test, called the Viasure SARS-CoV-2 Variant Real Time PCR Detection Kit for BD Max, identifies the Alpha, Beta, and Gamma variants of the coronavirus.

The test can be used in combination with a Viasure SARS-CoV-2 test that detects the virus' N1 and N2 genes, or used as a reflex test to identify the presence of variants in positive samples, the firms noted in a statement.

"The SARS-CoV-2 virus has shown rapid mutation, and the ability to monitor variants that have the potential for increased severity or transmissibility is a critical tool in the fight against this virus," said Fernand Goldblat, vice president and general manager of integrated diagnostic solutions for BD in Europe, the Middle East, and Africa. "Along with sequencing, diagnostic screening assays are an important part of the strategy to identify, differentiate, and contain variants of concern," Goldblat said.

The Viasure SARS-CoV-2 assay and variant assay can used with nasopharyngeal, oropharyngeal, and saliva sample types.

"Since the same single specimen can be used to run both assays to detect SARS-CoV-2 and test for its variants, the system provides a comprehensive solution for SARS-CoV-2 testing," noted Nelson Fernandes, managing director of CerTest Biotec.

On a call to discuss its fiscal third quarter results this week, BD also said it expects to begin shipping combination influenza and SARS-CoV-2 assays for the BD Max system this month. Along with CerTest, BD also markets a CE-marked Viasure combination SARS-CoV-2, influenza, and respiratory syncytial virus assay.