Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Get email alerts on the Liquid Biopsy topic
No spam. Unsubscribe anytime.
BioCore urges crosswalks for plasma liquid biopsy and MRD assays, citing distinct workflow complexity
Summary
BioCore recommended crosswalking a plasma-focused liquid biopsy (0562U) to a more complex comparator and sought gap-fill for whole-genome-based MRD assays (0646U/0647U), arguing the assays’ WGS workflows and variant classes are not reflected in prior CMS crosswalks.
Taylor Jensen, vice president and head of science for oncology at BioCore, told the CMS panel that 0562U (a plasma-focused liquid biopsy) and their MRD tests rely on complex next-generation sequencing workflows and recommended different crosswalks than prior CMS determinations.
Jensen said the PgDx plasma-focused assay measures single-nucleotide variants, indels, copy-number alterations and fusions across many genes and argued that it should be crosswalked to 20388U rather than the previously used 81445 because of broader variant classes and workflow complexity. On MRD, he described 0646U as a baseline MRD assay that uses whole-genome sequencing of tumor tissue, white blood cells and plasma to generate a patient-specific fingerprint, and 0647U as the longitudinal monitoring complement, and he said no comparable CDLT exists for the WGS-based workflow.
Why it matters: CMS crosswalks determine Medicare payment for new laboratory-developed tests. BioCore asked the panel to recognize analytic complexity—beyond simple gene counts—when selecting comparator codes and to allow gap-fill where no analog exists.
Panel discussion focused on sequencing depth, specimen types and operational resource demands. A panel member asked about read depth and the effect on per-test cost; Jensen said tumor sequencing is performed at ~80x, buffy coat ~40x and cell-free DNA around 40x and described a cumulative sequencing burden distinct from deeply sequencing a few targeted loci. Jensen told the panel the company believes these resource and content differences justify crosswalks or gap-fill treatment.
