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TrueDiagnostic argues CLFS crosswalk for 12 methylation‑based tests to 0020M
Summary
TrueDiagnostic presented a suite of 12 DNA methylation diagnostic assays across psychiatry, neurology, hepatology and other indications and asked CMS to crosswalk many to 0020M, citing shared Illumina array platform, bisulfite conversion workflow and algorithmic binary outputs.
Mike Mallon, chief scientific officer for TrueDiagnostic, presented a portfolio of 12 methylation diagnostic PLAs (0616U–0627U) that use a common wet‑lab workflow (DNA extraction, bisulfite conversion, methylation array profiling) and proprietary algorithms to report a binary positive/negative result for each indication.
He said the tests differ mainly in the number and choice of interrogated CpG loci (ranging from ~5,000 to 30,000) and in clinical indication (psychiatry, neurology, hepatology, autoimmune, COPD, Lyme disease), but argued the dominant cost drivers are analytical and post‑analytical steps (array consumables, Illumina instrumentation, skilled labor and bioinformatics). TrueDiagnostic recommended crosswalking most of the suite to PLA 0020M (epignostic CNS methylation classifier) because of platform and algorithm equivalence, while noting potential alternative comparators for some indications.
Nut graf: TrueDiagnostic emphasized that identical laboratory platform and algorithmic pipelines, even across diverse clinical uses, support a common CLFS comparator for pricing; CMS panelists asked clarifying operational questions (array use, director sign‑off and example report format) that the vendor answered during discussion.
The transcript records detailed methodological description, statements about report format (binary positive/negative) and assurances of laboratory QC and director review; panelists requested written clarifications on reflex rates to long‑read confirmation and example reports.
