Precision4Med_Nov2021_AdvancementsInPrecisionDiagnostics - 10

The Evolution of COVID-19 Diagnostics
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.
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
10 | GENengnews.com
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, the 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
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Precision4Med_Nov2021_AdvancementsInPrecisionDiagnostics

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