Company has recently confirmed diagnostic positive performance of its most advanced product, Genomtec® SARS-CoV-2 EvaGreen® RT-LAMP CE-IVD Duo Kit (in short RT-LAMP Duo Kit) against three published variants. i.e., namely the British variant (known as VUI-202012/01, lineage B1.1.7), the South African variant (known as 501Y.V2, lineage B1.351), and the Brazilian variant (lineage B.1.1.248). In the light of the latest news from France on the identification of yet another SARS-CoV-2 Variant Under Investigation (VUI), currently named “Breton Variant” (hCoV-19/France/BRE-IPP04233/2021) that may evade molecular testing more effectively compared to other variants, Genomtec SA has updated Kit’s performance status.
The conducted bioinformatic (in-silico) as well as wet lab analysis fully confirmed Kit’s reliability in recognition of Breton Variant. Currently, limited information is available on the Breton Variant’s transmissibility, virulence or immune evasion, however, it’s potential to escape standard RT-PCR testing analysis from swab-based samples has been confirmed. Recognition of the Breton Variant by RT-LAMP Duo Kit is important to ensure public health safety where accurate testing against multiple types of SARS-CoV-2 variants is absolutely crucial in sustaining efforts against pandemic control.
Miron Tokarski, Chief Executive Officer of Genomtec S.A., stated:
“The result gives assurance to our Customers worldwide that our Product (RT-LAMP Duo Kit), remains effective in detecting the new Breton Variant, along with previously identified SARS-CoV-2 variants. We are committed to constant diagnostic surveillance against newly appearing SARS-CoV-2 variants, ensuring ongoing products’ accuracy and performance. We stay in contact with relevant Governmental and Public Health Authorities to concentrate our efforts on deploying our test to laboratories, both private and public, and our Distributors in Poland and around the world.”
The result of the conducted investigation established that the RT-LAMP Duo Kit, a SARS-CoV-2 double gene target and an internal human control assay, successfully detects Breton SARS-CoV-2 strain (on top of the original lineage and previously published variants), giving confidence in product’s applicability for SARS-CoV-2 molecular diagnostic testing.