Dive Brief:

• Thermo Fisher Scientific said Monday FDA granted emergency use authorization for two COVID-19 assays designed to "compensate" for current mutations and emerging SARS-CoV-2 variants, as the delta variant spurs the latest surge of coronavirus cases across the U.S.
• The TaqPath COVID-19 Fast PCR Combo Kit 2.0 tests raw saliva with results in about two hours, according to Thermo Fisher. The TaqPath COVID-19 RNase P Combo Kit 2.0 has a three-hour turnaround time and is meant to detect SARS-CoV-2 from individuals suspected of COVID-19 by their healthcare provider as well as asymptomatic patients. The first generation TaqPath COVID-19 Combo Kit received an EUA from the FDA in March 2020. 
• FDA in January first reported PCR tests from Applied DNA Sciences, Mesa Biotech and Thermo Fisher may be affected by variants but said the impact does not appear to be significant, later adding Cepheid products.  

Dive Insight:

The emerging SARS-CoV-2 genetic variants, including the now dominant delta variant, has been an area of concern for the FDA. The agency has warned since the beginning of the year that variants arise regularly and false negative test results can potentially occur.

Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said at last week's virtual town hall for test developers the agency is continuing to assess whether existing diagnostics are able to properly detect new COVID-19 variants such as delta.

Stenzel said FDA has been asked by the Biden administration to ensure EUA-authorized tests are still performing despite the dramatic emergence of the delta variant and mutations. The agency is conducting its own bioinformatics search across all the tests and identifies potential issues, according to Stenzel.      

"Molecular, antigen, and serology tests are affected by viral mutations differently due to the inherent design differences of each test," states an FDA webpage which provides information about certain tests for which the agency has identified potential impacts on performance.

Stenzel said FDA has been "erring on the side of caution" by posting results of its analysis on the webpage. FDA's analysis to date has identified EUA-authorized molecular tests from Applied DNA Sciences, Cepheid, Mesa Biotech and Thermo Fisher whose performance could be impacted by SARS-CoV-2 viral mutations. 

Stenzel hastened to add that none of the diagnostics from the four molecular test makers listed on the FDA website have demonstrated a loss of sensitivity of 5% or greater, which the agency currently defines as a "significant" decrease for any of the variants of concern or mutations in the U.S.   

While the agency contends that molecular tests that use multiple genetic targets to determine a final result are less likely to be impacted, FDA recommends clinical laboratory staff and healthcare providers using SARS-CoV-2 tests "consider repeat testing with a different EUA authorized or FDA cleared molecular diagnostic test (with different genetic targets) if COVID-19 is still suspected after receiving a negative test result."  

Thermo Fisher contends that its next-generation TaqPath COVID-19 Fast PCR Combo Kit 2.0 and COVID-19 RNase P Combo Kit 2.0, targeting eight different genes across three regions of the virus, are both highly accurate assays with "increased target redundancy to compensate for current mutations and emerging SARS-CoV-2 variants." The company makes the case that the "built-in redundancy" will help ensure accurate test results in situations where gene expression in the virus vary as new mutations emerge.  

Since early 2021, PerkinElmer and Thermo Fisher have expanded their respective SARS-CoV-2 assays to help laboratories identify mutations associated with the rapidly emerging variants. However, surging cases of the dominant delta variant has so far not translated into sales. 

Thermo Fisher in late July reduced its COVID-19 testing revenue guidance by $900 million for the rest of the year. The company now expects at least $4.9 billion in revenue for 2021, of which $3.8 billion was delivered the first half of the year, leaving nearly $1 billion in expected revenue remaining.  ​

Nonetheless, CFO Stephen Williamson in a July 28 second-quarter earnings call told investors "there continues to be a wide range of outcomes for testing in the second half of the year" including an intensification of the pandemic "driving a higher need" for COVID-19 tests with the emerging delta variant.

​Thermo Fisher earlier this year bought Mesa Biotech for $450 million in cash to bolster its rapid point-of-care testing.