Leading COVID-19 Test Makers Say Their Products Can Detect New Omicron Variant

The World Health Organization (WHO) has declared the new omicron (B.1.1.529) viral mutation a “variant of concern.” But leading makers of COVID-19 diagnostic tests in the US seem unfazed and insist that they’re prepared for the omicron challenge.

Do Current COVID-19 Tests Detect Omicron?

Omicron has now been reported in at least a dozen countries in Africa, Europe, the Eastern Mediterranean and Western Pacific regions, according to WHO. The last coronavirus variant to receive the WHO “variance of concern” label was the delta variant, which currently accounts for virtually all COVID-19 cases in the US.

One of the reasons the COVID-19 pandemic was so devastating is that the virus was an unknown entity for which lab tests hadn’t been designed. Now that the new omicron variant has emerged, there are widespread fears that we may be right back where we started. The encouraging news is that current COVID-19 tests have proven effective in detecting the delta variant.

COVID-19 Test Makers Say They’re Ready for Omicron

While omicron has yet to reach American soil, several of the nation’s leading makers of COVID-19 tests have expressed confidence that their products will prove capable of detecting the new variant.

On November 27, Abbott Laboratories issued a statement indicating that it’s monitoring the situation and is “confident” that its polymerase chain reaction (PCR) and rapid antigen tests can detect omicron, noting that those tests don’t rely on the spike gene to detect the virus. “We are actively collecting real-world samples and using viral cultures to verify that our tests continually detect circulating strains because we know how important it is that our tests can detect new variants regardless of where they are found,” the Abbott statement notes.

Two days later, Hologic stated that it has determined via analysis of genetic sequences that all three of its COVID-19 tests—the Aptima SARS-CoV-2 Assay, Aptima SARS-CoV-2/Flu Assay and Panther Fusion SARS-CoV-2 Assay—detect the new omicron variant. Other test makers that have issued statements of reassurance include:

• Thermo Fisher Scientific, which said that its two PCR TaqPath kits aren’t impacted by omicron;
• Qiagen, which announced that its PCR tests remain accurate and effective in detecting SARS-CoV-2 infections, including those caused by the omicron variant;
• Lucira Health, which stated that its assessment confirms the capability of the firm’s COVID-19 Check-It (OTC) and All-In-One (Rx) molecular self-test kits “to detect 100% of Omicron variant genome sequences analyzed”;
• PerkinElmer, which announced that none of the more than 30 mutations associated with the omicron variant impact its PCR-based diagnostic kits; omicron impacts the S gene of SARS-CoV-2, which the PerkinElmer assays don’t target for detection; and
• Becton Dickinson, which expressed confidence in the capabilities of both its PCR and rapid antigen tests to detect omicron.

Takeaway

The US Food and Drug Administration (FDA) has been continually warning labs and healthcare providers to consider the potential impact of viral mutations on COVID-19 test performance. This fall, the agency issued new rules requiring producers of molecular, serology and antigen SARS-CoV-2 tests that have received Emergency Use Authorization (EUA) to take additional steps to account for viral variants, including:

1. Updated Labeling Requirements: Test makers must revise their authorized labeling and submit the updated labeling to FDA as a supplement to the EUA within three months.
2. Performance Evaluation Requirements: FDA also required test makers to evaluate the impact of SARS-CoV-2 viral mutations on test performance. Evaluation for multianalyte tests must address the impact of SARS-CoV-2 viral mutations and all other target analytes. Evaluations must be performed on an ongoing basis and include any additional data analysis that the agency requests in response to performance concerns.
3. Additional Labeling Update Requirements: If requested by FDA, test makers must update their labeling within seven calendar days to include any additional labeling risk mitigations that the agency identifies with regard to the impact of viral mutations on test performance.