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Lucence LiquidHallmark Assay Gets Medicare Coverage for Advanced Solid Tumors

This article has been updated to clarify what the LCD covers and to note that the LCD pertains to Lucence, not Lucence Diagnostics, which is a separate business entity.

NEW YORK – Lucence announced this week that it received Medicare coverage for its LiquidHallmark blood-based assay for patients with all types of advanced, recurrent, relapsed, refractory or metastatic solid tumors.

The decision was supported by data from the prospective multicenter LIQUIK-01 study, which compared LiquidHallmark to tissue biopsy results in patients with advanced non-small cell lung cancer (NSCLC) and to Guardant Health's own liquid biopsy test, Guardant360.

LiquidHallmark is a next-generation sequencing (NGS) assay that enables comprehensive genomic profiling of circulating cell-free DNA by detecting clinically actionable mutations in 80 genes, according to information provided by MolDx, the technical assessment program administered by Medicare contractor Palmetto.

In a poster presented at the recent North America Conference on Lung Cancer, Lucence reported that the assay showed at least 93 percent concordance with tissue-based NGS across nine NSCLC biomarkers.

According to the presentation, LiquidHallmark also detected more tissue-confirmed and guideline-recommended biomarkers than Guardant360 among 151 patients with metastatic NSCLC. Specifically, LiquidHallmark detected 52 such biomarkers, compared to 45 via Guardant360.

The MolDx local coverage determination (LCD) for LiquidHallmark, L38043, also covers Guardant360, and states that "other liquid biopsies will be covered for the same indications if they display similar performance in their intended used applications to Guardant360."

Lucence CEO Min-Han Tan said in a statement that the coverage decision "broadens the accessibility of LiquidHallmark to a wider patient demographic, reinforcing our commitment to personalized cancer care."

Last year, MolDx agreed to cover LiquidHallmark under the same LCD for all guideline-recommended molecular biomarkers in advanced lung cancer only.