Lucence announced today that Palmetto GBA, a Medicare administrative contractor and leader in evaluating molecular diagnostic technology through its laboratory technology assessment group for the Molecular Diagnostics Services program (MolDX), has finalized a foundational Local Coverage Determination (LCD) for the LiquidHALLMARK assay. The LCD covers all nine NCCN guideline-recommended molecular biomarkers in advanced lung cancer patients using LiquidHALLMARK.
LiquidHALLMARK is Lucence’s next-generation sequencing (NGS) liquid biopsy test, which helps oncologists identify biomarkers in advanced cancer patients that may inform their treatment decisions. The policy provides for Medicare reimbursement for LiquidHALLMARK tests furnished to most Medicare fee-for-service patients with lung cancer who meet clinical criteria.
Dr Min-Han Tan, Founding CEO, remarked on the significance of this milestone, saying, “Over 150,000 lung cancer patients over the age of 65 are diagnosed every year in the United States. We are grateful that LiquidHALLMARK will be accessible to more patients in need, and confident that our technology can help inform treatment decisions in the fight against cancer.”
The LiquidHALLMARK test has shown 94.5-100% concordance with tissue-based profiling across nine guideline-recommended biomarkers in the interim results of LIQUIK, a prospective multi-center trial . In this head-to-head study, LiquidHALLMARK identified 24 out of 34 tissue-confirmed guideline-recommended biomarkers, versus 21 by an FDA-approved liquid biopsy test.
- Dawar et al. (2022 Oct 20-22). Amplicon-Based Liquid Biopsy Platform Complements Tissue Genotyping in Detection of Guideline-Recommended Biomarkers in Metastatic NSCLC [Poster]. International Society of Liquid Biopsy 4th Annual Congress, Miami, United States.