AMP offers laboratory perspective on reporting of incidental findings

AMP offers laboratory perspective on reporting of incidental findings

The Association for Molecular Pathology (AMP), a nonprofit organization serving molecular laboratory professionals, has announced that The Journal of Molecular Diagnostics is today publishing a Special Article titled, “Reporting Incidental Findings in Genomic Scale Clinical Sequencing—A Clinical Laboratory Perspective.” This paper offers new and important perspectives from the laboratory highlighting the need for increased understanding and transparency of complex genomic testing. It also outlines important recommendations, including the need for laboratories to establish clear and patient-friendly policies for delivering ancillary information generated from genome-wide genetic tests.

The AMP Incidental Findings Working Group, including authors of this paper, have closely followed the incidental findings debate since early 2013 when the American College of Medical Genetics (ACMG) published its guidelines on incidental findings reporting. These recommendations primarily focused on the content of secondary information obtained from genetic tests, and not the pitfalls of technology limitations, which has placed a significant burden on laboratories to educate patients as well as physicians about the strengths and limitations of genetic testing.

Laboratory regulation also plays an important role in how incidental findings are reported. Clinical Laboratory Improvements Amendments (CLIA) regulations, proficiency testing, lab accreditation, and other quality measures oversee and govern laboratories and the tests that they develop. If the U.S. Food and Drug Administration (FDA) steps in, as proposed in its recent draft framework, that could make access to important tests challenging.