2021 LS&HC Horizons - Flipbook - Page 8
8
Hogan Lovells
In vitro diagnostics
Within weeks of the COVID-19 outbreak, in vitro
diagnostics (IVDs) – which include, in particular,
diagnostic tests for SARS-CoV-2 – have taken the
central role in the battle to contain the pandemic.
IVD manufacturers responded by adjusting their
R&D resources to develop COVID-19 tests and
bring them to market. FDA also responded
quickly by providing guidance on its EUA policy
and authorizing SARS-CoV-2 tests since midMarch 2020, including molecular diagnostic tests,
antigen diagnostic tests, serology/antibody tests,
and tests for patient management.
FDA has been unprecedently flexible and innovative
in the regulation of EUA tests, while keeping the
rigorous standards for test performance and reliability.
This has required IVD manufacturers to quickly
adapt to the fast- changing regulatory landscape, and
to become nimbler to shift focus as needed due to
the ever-changing information that FDA and other
health authorities are learning about the disease, and
the evolving nature of the SARS-CoV-2 virus and
its variants. As the disease remains uncontained,
more IVD manufacturers are expected to enter this
market, while FDA is identifying priorities in the
review of hundreds of EUA applications to ensure
that certain tests can rapidly enter the market. These
FDA-prioritized tests include point-of-care tests, tests
that can process high volumes of samples, and home
use tests, which the agency views as providing the
greatest public health benefit to contain or identify the
spread of the virus. Companies need to be strategic in
developing their tests and engaging with FDA so that
their products align with FDA’s priorities for granting
EUA authorizations.
Hopefully sometime in 2021, when the COVID-19
crisis finally ends and the emergency declaration is
lifted, EUA test manufacturers will face the challenge
of obtaining traditional FDA premarket authorizations,
and they should plan on strategies for developing
clinical study plans to support the more rigorous
requirements for FDA clearance or approval of the
various assays.
Moreover, the volume of non-COVID-19 related
tests are also expected to explode as the result of the
backlog in development and delay in FDA review
due to the pandemic. Companies need to have plans
in place to be better positioned in the evolving
regulatory environment.
Randy Prebula
Partner, Washington, D.C.
randy.prebula@hoganlovells.com
Susan Tiedy-Stevenson
Senior Director, Washington, D.C.
susan.tiedy-stevenson@hoganlovells.com
Erkang Ai
Senior Associate, Philadelphia
erkang.ai@hoganlovells.com
