Click for my article in Clinical Chemistry’s 2020 Special Issue on Molecular Diagnostics entitled “Current Policy Challenges in Genomic Medicine.” An excerpt is below: “Background: Molecular genetic testing has raised a variety of policy issues, ranging from privacy to reimbursement. Recently, payment policies have become of paramount importance as Medicare implemented the first significant change to test pricing since 1984 and announced a broad national coverage policy for the use of next-generation sequencing (NGS) in cancer patients that contains significant restrictions. Regulatory and oversight concerns have been important topics for discussion as the US Food and Drug Administration (FDA), Congress, and stakeholders have focused on new approaches to regulation of laboratory-developed tests (LDTs). Patents on gene sequences and relationships between genetic variants and clinical phenotypes have been points of contention … Two Supreme Court cases invalidated patents on gene sequences and biological relationships, ushering in the era of NGS and precision medicine. … [A] … legislative proposal threatens to … restore gene patents as barriers to progress …” http://clinchem.aaccjnls.org/content/early/2019/10/31/clinchem.2019.308775