As COVID-19 Variants Evolve, We Stay One Step Ahead

We know that viruses evolve and variants emerge. Here's how we're monitoring and ensuring our tests hold up.

Diagnostics Testing|May.08, 2023

Viruses evolve.  That's what our nearly three decades of virus hunting and developing tests that detect infectious diseases has taught us. And as they evolve and encounter new places and people, variants will emerge.

On the front lines of the COVID-19 pandemic, we expected no different. That's why at the start of the pandemic, we developed 12 COVID-19 tests globally to detect the virus and our team of virus hunters make sure that our tests can continue to detect the different variants – from alpha to omicron to the next variant of interest.

While there are still unknowns about future waves, we can expect variants to emerge, making the identification, analysis, tracking and testing of COVID-19 paramount.

Variants of Concern: What You Need to Know

Because viruses can spread rapidly, developing myriad mutations along the way, the CDC raises a red flag when a new variant has evidence of:

  1. An increase in transmissibility

  2. More severe disease (for example, increased hospitalizations or deaths)

  3. Significant reduction in neutralization by antibodies generated during previous infection or vaccination

  4. Reduced effectiveness of treatments or vaccines

  5. Diagnostic detection failures

Variants that meet these criteria are known as variants of concern (VOC), and potentially require one or more public health actions like increased testing, research or local and regional efforts to control spread.

We asked our virus hunters about the latest variants of concerns to keep you informed on how our tests perform.

Current Variants of Concern

  • JN.1 is currently a variant of interest, as determined by the World Health Organization. JN.1 is an offspring of BA.2.86 that first emerged in August 2023. However, its prevalence is rising swiftly worldwide. Given this rapid spread on several continents, the WHO has now classified JN.1 as a variant of interest. The CDC determined that currently there is no evidence that JN.1 presents an increased risk to public health relative to other currently circulating variants.

    We are confident that our tests — both rapid (including BinaxNOW and Panbio) and PCR tests — continue to detect the virus.
  • Arcturus also known as XBB.1.16, became recognized as a variant of concern by the World Health Organization in January of 2023.  It is a subvariant of the highly contagious Omicron variant and was initially detected in January of 2023.

    While the Arcturus variant contains mutations on the spike protein, we are confident that our tests — both rapid (including BinaxNOW and Panbio) and PCR tests — continue to detect it, because our tests do not rely on the spike protein to detect the virus.
  • Omicron became recognized as a variant of concern by the World Health Organization in November 2021 and has continued to rapidly gain mutations. Some of the initial sub-lineages of the Omicron variant included BA.2, BA. 4 and BA. 5 and today, over 500 sub-linages of this variant circulate. As a whole, the WHO has said these Omicron variants have been more transmissible, tend to cause less severe disease compared to previous variants of concern and have mutations that help them escape built-up immunity more easily.

    The updated COVID-19 boosters, known as bivalent boosters, target the original SARS-CoV-2 virus as well as the Omicron BA.4 and BA.5 subvariants. Testing also remains an effective method for detecting and preventing further spread of Omicron.

    While the Omicron variant contains mutations to the spike protein, we’re confident that our tests continue to detect Omicron because our tests do not rely on the spike gene to detect the virus. Our team of researchers has confirmed that our rapid (including BinaxNOW and Panbio) and PCR tests continue to detect the Omicron variant and its sub-variants. 
  • Delta (a collection of many AY lineages), a variant of concern that was first identified in India in late 2020 and spread throughout the world to ultimately cause a surge in the U.S. by summer of 2021, has been known to possibly spread more easily and cause more severe illness than other variants.

    Though vaccine breakthrough were expected, our August 2021 analysis found that our tests can detect the Delta variant and remain effective, helping to prevent further community spread of COVID-19.
  • Mu, a World Health Organization (WHO) variant of interest (VOI) that rose to prevalence in the summer of 2021, was thought to be more transmissible than all other variants with the exception of Delta, though it quickly fell to less than 1% of U.S. COVID-19 cases just weeks later.

    Our tests were confirmed to hold up against Mu in the fall of 2021.
  • R.1, a variant that the CDC noted had "mutations of importance" and "demonstrates evidence of increasing virus transmissibility," in the spring of 2021, was not classified as a variant of interest for the U.S.

    We ensured that our tests could detect R.1 in June of 2021.

Thankfully, with each variant of concern, we're not back at square one.

Thanks to the work of scientists, public health experts and officials across the world, the global community has an arsenal of critical tools in the fight against COVID-19:

  • Vaccinations and boosters to prevent severe illness
  • Public health measures like distancing and hand washing to prevent viral spread
  • Testing to isolate those infected with COVID-19 quickly and effectively to keep our workplaces, schools and communities safe.

As one of our lead virus hunters, Dr. Mary Rodgers, puts it: "We've been tracking viral mutations for over 27 years with our Viral Surveillance Program, so we expected SARS-CoV-2 to mutate since the beginning, as we've seen other viruses do."

Anticipating and monitoring viral evolution through initiatives like our Pandemic Defense Coalition, the first-ever industry-led scientific and global health partnership dedicated to the early detection of and rapid response to future pandemic threats, keeps us vigilant and prepared for future COVID-19 surges.

We know that testing remains an important line of defense against COVID-19. We'll stay on the lookout to ensure that our tests hold up to new variants, and are prepared to ramp up capacity of rapid testing solutions like our BinaxNOW COVID-19 Antigen Self Test and our Panbio COVID-19 Antigen Self Test to provide peace of mind where and when it’s needed most.

While viruses evolve, we are too.

The Panbio COVID-19 test is not available in all countries. Not approved for sale in the USA.

This story was originally published on April 29, 2022, and updated on Dec. 12, 2022, and May 8, 2023, and January 16, 2024


The BinaxNOW™ COVID-19 Antigen Self Test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization. It has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. For serial testing, the BinaxNOW COVID-19 Antigen Self Test should be performed twice over 3 days, at least 24 hours (and no more than 48 hours) apart. For symptomatic use, a single test can be used.