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AMP releases statement on diagnostics in drug labels
Date:5/16/2011

o sell its test exclusively to one laboratory, all specimens would have to be shipped to that laboratory for testing even if the source laboratory has access to a different FDA approved or cleared test for the same analyte. Dr. Lyon expressed AMP's concern, "this would drastically increase healthcare costs and over-complicate the laboratory environment. And our greatest concern is that it could result in restricting the patient's access to one specific test, which may create additional burdens to the patient including the collection of subsequent samples, increased out-of-pocket costs, and delayed treatment."

AMP hopes that this new position statement will encourage pharmaceutical companies to reference diagnostic tests based on its molecular description and the FDA to work with industry to reinforce the appropriate labeling of its products.

AMP's specific recommendations include:

  • To promote patient safety and high quality care, AMP recommends that FDA specify that diagnostics be described by the biological description of the gene or mutation in drug labeling and that identification of recommended diagnostic testing not be by brand name. Essential performance characteristics (e.g. limit of detection) can be specified. Standardized HUGO nomenclature should be used.

  • AMP notes that The Clinical Laboratory Standards Institute (CLSI) avoids identifying products by brand name in their Guidelines.

  • Identification of diagnostic tests by brand name in drug labeling is only appropriate in the description of relevant clinical studies; AMP recommends that in the remainder of the label, pharmaceutical manufacturers reference the biological description.


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

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