The FDA cleared Datar Cancer Genetics’ CellDx-Tissue assay, a dual DNA/RNA comprehensive genomic profiling test designed for solid tumors using formalin-fixed, paraffin-embedded tissue. The test runs targeted next-generation sequencing across 517 genes for variants and ERBB2 amplification, and uses RNA to call ALK, RET, and ROS1 fusions, enabling broader molecular decision support as targeted therapies evolve. Meanwhile, Personalis shares jumped after CMS expanded Medicare coverage for its NeXT Personal minimal residual disease assay to include immunotherapy monitoring across late-stage solid tumors. The decision—supported by evidence from a study with Spain’s Vall d’Hebron Institute of Oncology—extends NeXT Personal’s role beyond recurrence monitoring into active treatment management. Together, the actions reflect a regulatory-to-reimbursement pipeline that is increasingly important for liquid biopsy and tissue profiling companies, where coverage determines adoption and the speed of clinical uptake.
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