Advanced Biological Laboratories Obtained a Derogatory Authorization from the French National Agency for Medicines and Health Products Safety (ANSM) for its UltraGene Assay SARS-CoV-2 452R & 484K & 484Q Mutations

Advanced Biological Laboratories Obtained a Derogatory Authorization from the French National Agency for Medicines and Health Products Safety (ANSM) for its UltraGene Assay SARS-CoV-2 452R & 484K & 484Q Mutations

Advanced Biological Laboratories (ABL) announced today the obtention of a derogatory authorization from the French National Agency for Medicines and Health Products Safety (ANSM) for commercializing the UltraGene Assay SARS-CoV-2 452R & 484K & 484Q Mutations which meets sufficient performance to comply with safety requirements related to in-vitro diagnostics medical devices. This procedure helps proposing to the pathology laboratories a solution in the interest in the protection of public health to detect specific mutations identified for variants currently circulating.

The assay is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction (PCR) test (nucleic acid technique (NAT)) intended to screen the emergence of SARS-CoV-2 genome harboring the mutations L452R, E484K and E484Q on the Spike (S) gene. The test is targeting the S region of SARS-CoV-2 patients’ extracted RNA. This test is intended for use only on diagnosed PCR positive to SARS-CoV-2 with a test CE-marked and authorized by competent authorities for SARS-Cov-2 screening.

“This derogatory authorization will help laboratories to get immediate access to a simple and accurate test able to detect SARS-CoV-2 452R, 484K and 484Q key mutations, until CE marking is completed” said Dr Sayada, CEO of ABL.

To learn more about our SARS-CoV-2 Assays, please visit

https://www.ablsa.com/applications/coronavirus/