Assay Development

Assay Development

AMP members members are dedicated to the development and implementation of molecular pathology testing in a manner consistent with the highest standards established by the Clinical Laboratory Improvement Amendments (CLIA), the College of American Pathologists (CAP), the American College of Medical Genetics (ACMG), and the Food & Drug Administration (FDA). AMP members populate the majority of clinical molecular diagnostics laboratories in the United States, and their efforts are central to the generation of novel, high quality, molecular tests that are applied daily in medical decision-making. Assays designed within these laboratories are used for diagnosis, prognosis and patient management in all medical areas including cancer, infectious diseases, heritable disorders, and histocompatibility testing.

Laboratory Developed Tests
In recent years, there has been increased attention on the oversight of laboratory developed tests (LDTs) among policy makers, manufacturers, regulators and the laboratory community. These discussions include proposed changes to the current oversight mechanisms for LDTs, such as the creation of registries, expansion of FDA enforcement, strengthening of the CLIA program, and others. AMP believes that current mechanisms are sufficient in ensuring patient safety and broad access to high quality tests and, in January 2010, published a statement elucidating our position on the issue. Read the AMP position on LDTs.


Corporate Partners