On Mar. 15, 2022, Roche announced available testing solutions that can identify the SARS-CoV-2 B.1.1.529 variant and differentiate between the Omicron subvariants BA.1, BA.1.1, BA.2, BA.2.2, BA.3 and Delta. The available research use only tests – VirSNiP SARS-CoV-2 Spike S371L S373P and VirSNiP SARS-CoV-2 Spike S371L S373P 452R – add to the test kits previously developed by Roche and TIB Molbiol for the detection of the recent BA.1 and BA.2, as well as other mutations, present in the novel B.1.1.529 Omicron SARS-CoV-2 variant.

TIB Molbiol’s researchers work in collaboration with academic contacts to continually screen for new variants and emerging diseases. TIB Molbiol and Roche provided the first research use only SARS-CoV-2 detection test in January 2020 – only days after the new coronavirus was first sequenced.

A mix of other assays in the portfolio can be combined to further differentiate BA1.1, BA2.2 and BA.3. The mutations in all Omicron variants do not affect the performance of the TIB Molbiol LightMix® Modular SARS-CoV-2 (COVID19) N-gene, E-gene, nor RdRP-gene kits. These kits are launched globally (excluding the USA).

Roche also offers in vitro diagnostic (IVD) tests to accurately diagnose COVID-19. In addition, the cobas® SARS-CoV-2 Variant Set 1 test (RUO) for use on the cobas® 6800/8800 Systems is an automated, multiplex, real-time reverse transcription polymerase chain reaction (RT-PCR) assay for the rapid in vitro qualitative detection and discrimination of selected SARS-CoV-2 mutations E484K, N501Y and deletion HV-69/70.

This assay is predicted to detect mutations in the Omicron variant del 69-70 and N501Y in the spike protein. It can therefore be used as a tool to presumptively identify Omicron. In addition BA.1 has both mutations (del 69-70 and N501Y) while BA.2 lacks the del 69-70 and therefore should produce different mutation patterns in this assay. Roche is currently working to generate additional data to supplement our analysis around this test. The test is designed to be used with known SARS-CoV-2 positive samples and to support the understanding of variant epidemiology for Population Health Management.