AMP presents at FDA meeting on regulating diagnostics

College Park, MD (July 20, 2010): The Association for Molecular Pathology (AMP) participated in the
Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) public
meeting on the oversight of laboratory developed tests (LDTs). Dr. Karen Mann, President of AMP,
served on the second panel of the meeting titled, Clinical Laboratory Challenges. Additionally, Dr.
Elaine Lyon, Chair of the AMP Professional Relations Committee, presented public comments.
“AMP believes that LDTs are an essential and central component of medical practice,” said Dr. Lyon,
“Without LDTs, the practice of medicine that we know today would be severely reduced in scope.”

LDTs continue to play essential and formative roles in delivery of preventative care, diagnosis, and
disease management, and AMP believes that only high quality, clinically and analytically valid diagnostic
tests should be performed in clinical laboratories. Also, all laboratories should meet CLIA standards,
adhere to established guidelines, and seek appropriate certifications and accreditations.

AMP believes that a regulatory model should not interfere with the practice of medicine, and it is
important to recognize the value of the current oversight system for enabling clinical laboratories to
rapidly incorporate new findings into practice and to modify existing laboratory tests and their usage in
accordance with advances in our understanding of clinical utility and disease pathogenesis. Dr. Lyon
noted, “Nimble innovation in new test development is crucial to our ability to respond to emerging public
health challenges, which was evident during the 2009 H1N1 influenza outbreak.”

There is a lack of review of current and proposed oversight models. In its remarks, AMP encouraged the
FDA to collect data and assess the effectiveness of existing oversight models prior to implementing new
approaches, as it will be extremely important to demonstrate that any proposed oversight system would
lead to improved health outcomes.

AMP believes that LDTs in all disciplines of laboratory medicine should be subject to the same oversight
mechanisms, and that molecular or genetic tests should not singled out for heightened scrutiny simply due
to the heritable nature of nucleic acids. AMP does agree that some tests may require greater scrutiny and
may warrant additional regulatory review. An LDT that may require further regulation is one that:

  • Uses a non-transparent algorithm with multiple markers that cannot be elucidated by other test
    developers, or
  • Relies on technology that is not easily replicated by multiple laboratories, and for which
    • a false result would cause significant morbidity or mortality, or
    • a false result could have a widespread adverse effect for public health

However, Dr. Lyon expressed concern about the impact on low volume tests, “We feel it’s important to
recognize the potential impact of increased oversight on infrequent or low volume tests. Overzealous
regulation of such tests could prove to be overly burdensome and cost prohibitive for laboratories
developing and offering important but infrequently utilized tests.”

To advance the field of molecular pathology, any new oversight policy should also work to address the
barriers to test development. Specifically, AMP believes the recognition and implementation of advances
in medical research may be hindered by a lack of certified reference materials and encourages the
government to support the development of these materials at the National Institute of Standards and
Technology. Dr. Lyon explained, “Molecular assays provide the cutting edge for many individualized
therapies in oncology, transplantation, infectious disease and genetics, but the production of certified
reference materials has fallen far behind the technical capabilities of these assays which are needed to
ensure sensitivity, specificity and reproducibility of intra- and inter-laboratory test results.”

A major hurdle for laboratories is the reimbursement of diagnostic tests. Escalating costs for test
development, performance, interpretation and reporting, compounded with additional costs to satisfy new regulatory requirements could result in the elimination of important clinical tests. In considering
revisions to the current oversight processes, AMP urged FDA to realize the potential ramifications on test
availability due to economic considerations.

Lastly, AMP recommended that the FDA convene an external advisory committee composed of
individuals with expertise in the relevant diagnostic areas to assist in identifying the appropriate risk
classifications. Dr. Lyon said, “There is much debate in the community about the criteria used to group
LDTs into low, medium and high risk categories. An external advisory committee would be a very
valuable tool for the FDA as it works to make these determinations.”

Dr. Lyon concluded, “As the FDA considers its approach to regulating LDTs, AMP encourages the
agency to consider the unanticipated effects that significant modifications to the current oversight system
could represent for clinical laboratories.” These unanticipated effects include the possibility that
laboratories may be compelled to discontinue services and/or potentially lose flexibility to rapidly
introduce and continually improve tests, all of which would adversely impact delivery of effective care to
our patients.

In holding this meeting, AMP believes that the FDA has taken an important step forward and AMP looks
forward to partnering with the FDA and continuing to work with the Agency for the benefit of patients.

About AMP:

The Association for Molecular Pathology (AMP) is an international medical professional association
dedicated to the advancement, practice, and science of clinical molecular laboratory medicine and
translational research based on the applications of molecular biology, genetics and genomics. For more
information, please visit:

The material in this press release comes from the originating research organization. Content may be edited for style and length. Have a question? Let us know.


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