LSHC Horizons Brochure 2024 - Flipbook - Page 23
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | Cell, Tissue, and Gene Therapies
23
Laboratory developed tests under FDA scrutiny
“Precision” or “personalized” medicine seeks
to provide a bespoke therapy for the right
patient – with the right treatment at the
right time – by adjusting for the nuances
within an individual’s genetic profile, health
records, and lifestyle. These drugs can
produce unprecedented clinical effect with
low toxicity compared to other therapies by
relying on molecular structures that are not
present in all patients. For example, patients
may be screened by identification of novel
biomarker(s) to guide clinical decisions. The
recent clear trend is towards an increase in the
number of precision therapeutic products that
have received regulatory approval dependent
upon the development and validation of
a biomarker assay, such as a companion
diagnostic (CDx) test.
However, given that today’s LDTs often rely on
highly specialized components with complex
functionalities involving bioinformatics, software
development, and underlying specialties such as
genetics for next generation sequencing (NGS)
test systems, FDA has become increasingly
concerned that such tests are being offered
without assurance that they work.
The FDA has signaled its intention to finalize
the proposed LDT rule by April 2024. Although
the FDA faces numerous hurdles before final
implementation, the interplay between drug
and device approvals is clearly under scrutiny
and only becoming more complex. Industry
stakeholders must plan accordingly to futureproof their development strategies.
In addition, FDA has recently announced
a landmark proposed rule, which would
make explicit that certain in vitro diagnostic
products (IVDs) that are laboratory developed
tests (LDTs) are medical devices as defined
by the Federal Food, Drug, and Cosmetic
Act (FDCA) and will be regulated by the
Agency accordingly, including requiring
premarket review. Historically, the FDA
has not attempted to require compliance
for LDTs, with the exception of certain test
categories, such as direct-to-consumer tests,
some pharmacogenomic (PGx) tests, and tests
that respond to public health emergencies.
Blake E. Wilson
Partner
Philadelphia
Lowell M. Zeta
Partner
Washington, D.C.
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