Emerging Testing Technologies Offer Potentially Significant Improvements for COVID-19 Screening Programs
The Situation: New COVID‑19 testing technologies may provide for more reliable and less invasive options for use in COVID‑19 screening programs by employers and others.
The Action: The U.S. Food and Drug Administration ("FDA") recently authorized the first emergency use of a molecular COVID‑19 test to screen asymptomatic individuals without reason to suspect COVID‑19 infection. Additionally, new data is emerging to suggest that saliva testing may be more effective at detecting COVID‑19 than widely used, and more invasive, nasopharyngeal testing.
Looking Ahead: Employers and others who have implemented or are interested in implementing a COVID‑19 screening program should continue to monitor developments in testing technologies, including saliva testing technologies and testing specifically authorized by FDA to screen asymptomatic persons. Remaining nimble to adopt newer and better technologies in this rapidly developing environment will help employers and other entities optimize COVID‑19 screening programs and mitigate business disruptions and potential liabilities.
COVID‑19 screening programs intended to identify individuals infected with SARS‑CoV‑2, the virus that causes COVID‑19, continue to be of interest for employers and others. Combined with other infection control and prevention strategies, a well-designed and lawfully implemented COVID‑19 screening program can be one potential safety tool in a comprehensive return-to-workplace plan. Indeed, the Equal Employment Opportunity Commission ("EEOC") explained in guidance issued in April 2020 that, in the context of the coronavirus pandemic, "an employer may choose to administer COVID‑19 testing to employees before they enter the workplace to determine if they have the virus." The EEOC cautioned employers, however, that such testing must be accurate and reliable, and recommended employers review guidance from the FDA, the Centers for Disease Control and Prevention ("CDC"), and other public health authorities in making that determination.
Until recently, FDA had not authorized any COVID‑19 testing technologies for use in testing asymptomatic persons without any reason to suspect infection. Furthermore, recent data is emerging to challenge the use of nasopharyngeal swab specimen collection as the most reliable method for testing individuals for the presence of COVID‑19. These recent developments indicate a need for employers and others to stay abreast of testing technology developments and remain nimble in developing and operationalizing COVID‑19 screening programs.
FDA Issues First Emergency Use Authorization ("EUA") for COVID-19 Screening Test
On July 24, 2020, FDA for the first time authorized a COVID‑19 molecular test for screening patients in the absence of symptoms or a known or suspected exposure. Molecular testing (i.e., testing body fluids such as saliva or respiratory specimens for the presence of the SARS‑CoV‑2 virus) is one type of COVID‑19 testing technology being used for diagnosing COVID‑19 in its active state. Upon reviewing data submitted by the manufacturer for its COVID‑19 RT‑PCR Test, FDA reissued and expanded the EUA and indicated in its press release that the manufacturer "provided scientific data … that the test is as accurate in the broader asymptomatic population as it is among people suspected to have COVID‑19."
In addition to this July 24, 2020, EUA reissuance, emerging clinical data indicates that molecular testing using saliva sampling may be more sensitive for detecting the presence of the SARS‑CoV‑2 virus than widely used nasopharyngeal sampling. Some of this data suggests that saliva testing may detect the presence of SARS‑CoV‑2 several days before nasopharyngeal swabs turn positive. In addition to potentially greater sensitivity and reliability, saliva testing is associated with fewer complications and greater testing compliance than nasopharyngeal testing due to its less-invasive sample collection process.
While testing resources remain an issue, these are critical developments for all entities that are conducting or planning to conduct COVID‑19 screening programs.
As new technologies are reviewed by FDA and test manufacturers accumulate data to demonstrate utility in asymptomatic populations, employers and others with testing regimens are encouraged to revisit existing protocols, both to confirm the program is meeting its intended goals and to mitigate liability risks (e.g., potential claims stemming from reliance on false-negative test results or complications with test administration). As the developments described in this Commentary highlight, employer testing must be treated as dynamic and evolving, rather than stagnant and final. There may be a point when FDA's emergency authorization of tests specifically for use in asymptomatic persons or the strength of the data supporting the effectiveness of saliva-based testing becomes compelling enough that a company could face increased liability for continuing to use tests without such authorization or tests with nasopharyngeal specimen collection. Thus, consistent with EEOC guidance, employers (and others) that have implemented COVID‑19 screening programs should continue to review the latest updates from FDA, the CDC, and other public health authorities in this area.
For those entities that are thinking about adopting testing protocols, these new developments offer a promising path forward for testing modalities that could be more reliable and more tolerable. Caution is warranted, however. Early in the COVID‑19 outbreak in the United States, the market was flooded with antibody tests, including test kits with dubious reliability, and fraudulent molecular tests. This possibility remains. In addition to appropriately vetting vendors and their offerings, the rapidly changing scientific and legal landscape also cautions against contracting with vendors under terms that lock employers into certain tests and testing protocols that may become outdated as new and better tests and testing strategies become available.
Three Key Takeaways
- On July 24, 2020, FDA authorized the first emergency use of a COVID‑19 molecular test for screening asymptomatic people without any reason to suspect infection.
- Although not yet conclusive, clinical data is emerging that indicates that testing saliva specimens for the presence of SARS‑CoV‑2 virus is more sensitive and reliable than testing with widely used nasopharyngeal specimens.
- Employers and others who have implemented (or intend to implement) COVID‑19 screening protocols should stay abreast of developing technologies for use in screening asymptomatic people. As the science changes, so too will the legal risks associated with a testing program. Those responsible for COVID‑19 screening programs should routinely review and update their programs to help make them most effective without carrying undue or unwanted risk.
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