WASHINGTON, April 30,
2024 /PRNewswire/ -- The Food and Drug
Administration's (FDA) final rule has reclassified laboratory
developed tests (LDTs) as medical devices, according to Avalere.
The rule lead to a paradigm shift that will create new burdens on
laboratory manufacturers.
"By explicitly defining LDTs as a type of in-vitro diagnostic
tests (IVDs), LDTs become subject to FDA enforcement both pre- and
post-market, affecting commercialization through requirements for
an expanded level of evidence demonstrating safety and efficacy,"
said Laura Housman, Practice
Director for consulting firm, Avalere, part of Avalere Health.
There are more than 300,000 laboratories in the U.S., according
to the American Clinical Laboratory Association. Only an estimated
12,000 labs are certified to develop and deploy LDTs. Examples of
LDTs include:
- Coronavirus/COVID 19 tests obtained for the nasal passages
- Flu tests on fluid obtained from the lower respiratory
tract
- Genetic tests, such as BRCA for breast cancers, and
genetic tests for rare diseases, such as Huntington disease
- Predictive and prognostic screening and diagnostic tests for a
range of diseases, such as colorectal cancer, breast cancer, and
diabetes
"The FDA rule changes the paradigm," noted Housman. "Diagnostic
manufacturers will need to consider adapting current development
and commercialization strategies in response to policy changes.
Pharmaceutical sponsors with therapeutics that rely on biomarker
diagnostics will have a new set of considerations as they map their
companion diagnostic partnership strategies."
Avalere experts have begun alerting laboratory developers
and manufacturers about the implications of the new rule and
provided the following recommendations for these companies to
consider:
- Reevaluate marketed and pipeline diagnostics in light of FDA
requirements
- Reassess prioritization of products based on market potential
and evidence burden
- Establish and expand evidence generation, including health
economics and outcomes research
- Capitalize on the value of real-world data
- Assess development and commercialization opportunities with new
targeted evidence
- Collaborate with partners to enhance treatment access
About Avalere
Avalere, part of Avalere Health, is a strategic advisory company
whose core purpose is to create innovative solutions to complex
healthcare problems. Based in Washington,
D.C., the firm delivers actionable insights, product
solutions and custom analytics for leaders in the healthcare
business and policy. Avalere's experts span 230 staff drawn from
Fortune 500 healthcare companies, the federal government (e.g.,
CMS, OMB, CBO and Congress), top consultancies and nonprofits. The
firm offers deep substance on the full range of healthcare business
issues affecting the Fortune 500 healthcare companies. Avalere's
focus on strategy is supported by a rigorous, in-house analytic
research group that uses public and private data to generate
quantitative insight. Through events, publications and interactive
programs, Avalere insights are accessible to a broad range of
customers. For more information, visit avalere.com, or follow us
on LinkedIn.
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SOURCE Avalere Health