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AMP presents at FDA meeting on regulating diagnostics
Date:7/20/2010

sed 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,
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Contact: Mary Steele Williams
mwilliams@amp.org
301-634-7921
Association for Molecular Pathology
Source:Eurekalert

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