AMP lays out clinical utility standard for molecular Dx

The Association for Molecular Pathology has published a 14-page report its leaders hope will reset the conversation payers, policymakers, and medical guideline panels have when assessing the clinical utility of molecular diagnostics in oncology and inherited diseases. The key to AMP’s approach is to broaden the standard for what is considered a clinically useful molecular diagnostic test.

“We tried to take an inclusive approach and look at patients, providers, and clinicians, and we tried to address clinical utility from all those standpoints,” says Elaine Lyon, PhD, co-chair of the AMP Framework for the Evidence Needed to Demonstrate Clinical Utility Task Force. The panel met for two years to develop the document, “The Spectrum of Clinical Utilities in Molecular Pathology Testing Procedures for Inherited Conditions and Cancer: A Report of the Association for Molecular Pathology” (Joseph L, et al. J Mol Diagn. 2016;18[5]:605–619).

My latest in CAP TODAY’s “Put It on the Board” section. Read the whole shebang.