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LabCorp presents NIST 2+ MASH assay and proposes adjusted crosswalk price
Summary
LabCorp described PLA X259U (NIST2+), an ELISA and RT‑qPCR algorithm that reports a single MASH fibrosis/activity score and asked CMS to crosswalk from an earlier PLA while subtracting legacy components to set a final rate of $226.60.
Marge Connolly, strategic director of diagnostics research and development at LabCorp, presented PLA X259U (NIST2+), a combined ELISA and RT‑qPCR test that reports a single algorithmic score intended to classify metabolic dysfunction‑associated steatohepatitis (MASH) activity and fibrosis.
Connolly described testing steps: measurement of YKL‑40 (CHI3L1) by ELISA, quantification of miR‑34a by RT‑qPCR, and an algorithm that adjusts for a patient’s sex to produce a single reportable risk/fibrosis score. She said the NIST2+ assay is an optimized successor to a previous NIST4 test that removed HbA1c and alpha‑2 macroglobulin from the panel and that LabCorp proposed subtracting those historical component rates ($25.10) from the predecessor PLA to arrive at $226.60.
Nut graf: LabCorp argued that the optimized biomarker set and algorithm increase the assay’s ability to detect MASH with fibrosis and that rate‑setting should reflect the current two‑marker algorithm rather than the earlier four‑component test. The presenter invited questions on methodology and comparators.
The transcript shows an exchange of clarifying slides and no formal challenge from the panel in the recorded segment; CMS panelists acknowledged the presentation and moved to the next speaker.
