WASHINGTON, June 25,
2024 /PRNewswire/ -- Today, the Association for
Diagnostics & Laboratory Medicine (ADLM, formerly AACC)
released the results of a survey that ADLM conducted to determine
how the Food and Drug Administration's (FDA's) final laboratory
developed tests rule will impact patient access to essential tests.
The survey found that, in spite of certain tests being exempt from
the rule, it will still force many laboratories, particularly those
in hospitals, to discontinue critical tests, including those needed
to identify prescription and illegal drug use.
View the full survey results here:
https://www.myadlm.org/lp/ldts-survey
On April 29, the FDA published a
final rule on laboratory developed test regulation that will place
these tests under FDA oversight, in addition to the Centers for
Medicare & Medicaid Services (CMS) oversight that they are
already under. ADLM has long contended that labs do not have the
resources to meet the FDA's regulatory requirements on top of CMS',
and that this duplicative regulation will push many labs to stop
performing these essential tests. The FDA, on the other hand, has
emphasized that the final rule exempts certain categories of
laboratory developed tests from the agency's full review process,
though exempt tests will still be subject to other regulatory
requirements. These exempt tests include so-called grandfathered
tests that were offered prior to the publication of the rule, as
well as tests that fill an unmet need that no FDA authorized test
addresses. After the rule is phased in, which will happen over the
course of 4 years, the FDA claims that these exemptions will ensure
that patients have the same access to testing that they do in the
present.
ADLM conducted a survey to learn directly from labs whether the
FDA rule's exemptions will help or hurt their testing capabilities.
The survey went out to clinical laboratories across the U.S. and
received responses from 128 of them. In spite of the rule's
exemptions, the majority of respondents said that they do not have
the staff or resources to fulfill the FDA requirements that exempt
laboratory developed tests will still have to meet. And more than
half of the labs that won't be able to comply with these
requirements anticipate discontinuing some of their exempt
tests.
The tests that labs could end up discontinuing include essential
toxicology tests for fentanyl, methamphetamine, barbiturates, and
cocaine. These laboratory developed drug tests are crucial because,
unlike their FDA approved counterparts, they are able to detect
these drugs at their lowest concentrations. Labs can also modify
their laboratory developed tests quickly, enabling them to detect
designer drugs as soon as they emerge. This makes these tests
indispensable in the fight to curb substance abuse and overdose
deaths, which surpassed 100,000 for the third straight year in
2023.
"We appreciate that the FDA has tried to include provisions in
its final rule with the aim of preserving patient access to
laboratory developed tests," said ADLM President Dr. Octavia Peck Palmer. "But the fact still remains
that clinical labs are not medical device manufacturers, nor are
laboratory developed tests the mass manufactured devices that the
FDA currently regulates. This means that the FDA's regulatory
framework is simply not appropriate for laboratory developed tests,
and the results of ADLM's survey demonstrate that placing these
tests under FDA oversight will only hinder patient care and
critical public health initiatives."
About laboratory developed tests
A laboratory developed test is a new or significantly modified
test that is developed, validated, and used within a single
clinical laboratory in response to a specific patient care need.
Most laboratory developed tests are created because there is not
already a Food and Drug Administration-approved test available, and
they are often used to diagnose rare conditions, such as inherited
genetic disorders. These tests are typically not advertised or sold
as kits to other testing facilities.
The only labs that are allowed to perform laboratory developed
tests are those that are considered high-complexity labs under the
Clinical Laboratory Improvement Amendments, which are administered
by the Centers for Medicare & Medicaid Services (CMS). These
high-complexity labs are subject to rigorous oversight under CMS,
and they are routinely inspected to ensure that they provide highly
accurate testing.
About the Association for Diagnostics & Laboratory
Medicine (ADLM)
Dedicated to achieving better health through laboratory
medicine, ADLM (formerly AACC) brings together more than 70,000
clinical laboratory professionals, physicians, research scientists,
and business leaders from around the world focused on clinical
chemistry, molecular diagnostics, mass spectrometry, translational
medicine, lab management, and other areas of progressing laboratory
science. Since 1948, ADLM has worked to advance the common
interests of the field, providing programs that advance scientific
collaboration, knowledge, expertise, and innovation. For more
information, visit www.myadlm.org.
Christine DeLong
ADLM
Associate Director, Communications & PR
(p) 202.835.8722
cdelong@myadlm.org
Molly Polen
ADLM
Senior Director, Communications & PR
(p) 202.420.7612
(c) 703.598.0472
mpolen@myadlm.org
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SOURCE Association for Diagnostics & Laboratory Medicine
(ADLM)