u/Incognew01

The author argues Medicare's MolDX program proposed an LCD recognizing genome-wide structural variant testing as a clinical category, placing optical genome mapping (OGM) alongside karyotyping and microarray for the first time, which would open reimbursement. New York's approval of OGM at the University of Rochester is claimed to drive adoption at other academic centers, and Bionano's Purigen OGM-Dx HemeOne is described as one of the few genome-wide assays with completed analytical validation, ready to run once MolDX finalizes coverage. The author expects updated AML and constitutional disorder data at fall conferences to strengthen the case against karyotyping, with the market having priced in none of this. Main risk implied is dependence on MolDX finalizing coverage and clinical adoption materializing.