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As more contagious variants continue to emerge and vaccinations happen more slowly than expected, experts believe it is unlikely that herd immunity to COVID-19 will be within reach anytime soon.1 Instead, SARS-CoV-2 is likely to become endemic, persisting in most parts of the world as a constant, but less lethal threat. The rapid development of a multitude of SARS-CoV-2 detection tests played a critical role in mounting a pandemic response. As COVID-19 transitions to its endemic phase, however, development of the next generation of diagnostics will focus less on diagnosing infection and more on informing decisions about management and treatment of the disease.
COVID-19 Diagnostics at a Glance
Since the beginning of the global health crisis, the US Food and Drug Administration (FDA) has worked closely with diagnostic developers to facilitate access to COVID-19 testing and accelerate development of home-based tests. By creating a flexible regulatory framework, the agency has enabled Emergency Use Authorization (EUA) of nearly 400 tests and sample collection devices for SARS-CoV-2, including:2
- 281 molecular tests and sample collection devices, including 52 tests using home-collected samples, one prescription at-home test, and two over the counter (OTC) at-home tests
- 85 antibody and other immune response tests, including one using home-collected samples and three at-home tests
- 30 antigen tests, including three prescription at-home tests and five OTC tests
The Evolution of COVID-19 Diagnostics
In the months following the declaration of the public health emergency, diagnostics for SARS-CoV-2 and COVID-19 evolved quickly from hospital-based tests to point-of-care platforms that enabled specimen collecting and testing in non-hospital settings. FDA has been clear about the need to have tests that can be fully administered outside of the laboratory or healthcare settings and continues to prioritize reviews for home collection, home testing, point-of-care, and high throughput laboratory tests.3
Throughout the public health emergency, the FDA has been committed to providing timely guidance to support COVID-19 response efforts. In February 2021, the agency issued a suite of guidance documents addressing the emergence and potential emergence of SARS-CoV-2 variants.4 Among these, the Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests offers recommendations on evaluating the potential impact of viral genetic mutations on test design, performance, and monitoring.5
In March 2021, FDA granted the first de novo marketing authorization to the BioFire Respiratory Panel 2.1, a diagnostic test for simultaneous qualitative detection of multiple respiratory viral and bacterial nucleic acids, making it the first SARS-CoV-2 diagnostic test that could be marketed beyond the public health emergency.6 Equally significant, this approval established a new regulation and paves the way for other multi-pathogen tests, which will help distinguish among different upper respiratory infections (URIs). These tests will be critical as COVID-19 becomes endemic, as its treatment differs from other URIs.
Transitioning to Prediction and Prognosis
With the emergence of variants—such as the Delta variant—and phenotypes ranging from asymptomatic disease to rapid decline, it has become clear that COVID-19 will continue to be a persistent population health concern long after the public health emergency comes to an end. To effectively manage the systemic illness resulting from SARS-CoV-2 infection, appropriate prognostic and treatment-guiding tools will be required.
The next phase of COVID-19 research and development will be biomarker-driven. The Access to COVID-19 Tools (ACT)-Accelerator calls for molecular tools that can be used to identify biomarkers that address three key challenges that go beyond diagnosis:
- Assessing the efficacy of future vaccines or therapeutics
- Identifying and preventing clinical complications
- Stratifying patients for appropriate treatments
Investigations of a broad array of biomarkers for predicting COVID-19 severity and complications are underway. These biomarkers include well-established markers of inflammation such as interleukin-6 (IL-6) and cytokines such as LIGHT, which has been shown to play a critical role in regulating COVID-19 responses in the lung, gastrointestinal tract, and skin. Researchers, including Precision for Medicine’s specialty laboratories, are also studying immune cell responses to the SARS-CoV-2 virus.
Future COVID-19 diagnostics will likely rely on multiple biomarkers and algorithms to predict disease severity. Advanced bioinformatics methods are being applied to large data streams that integrate proteomic, immunomic, and genomic analysis to identify biomarker signatures that are both predictive and prognostic for COVID-19 disease. Precision for Medicine is supporting the development of Inflammatix’s InSep™️, a 29-mRNA classifier test that has demonstrated utility in predicting severity of infection.
1. The New York Times. Covid-19. Hopes for ‘Herd Immunity’ Fade as Virus Hurtles Toward Becoming Endemic. Published May 9, 2021. Updated July 30, 2021.
2. US Food and Drug Administration. FDA COVID-19 response at-a-glance summary. Published July 19, 2021.
3. Food and Drug Administration. Coronavirus (COVID-19) update: FDA authorizes first COVID-19 test for self-testing at home.
4. Food and Drug Administration. Coronavirus (COVID-19) update: FDA issues policies to guide medical product developers addressing virus variants.
5. Center for Devices and Radiological Health. U.S. Food and Drug Administration. Policy for evaluating impact of viral mutations on COVID-19 tests.
6. U.S. Food and Drug Administration. FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process.