PALO ALTO, CA January 2, 2025 — Lucence announced a decision by the Molecular Diagnostic Services (MolDX) Program allowing for Medicare coverage of its LiquidHALLMARK® ctDNA/ctRNA liquid biopsy test, effective October 2, 2024. This decision marks a critical step toward making advanced, minimally invasive diagnostic solutions more accessible, enabling personalized cancer care for more U.S. patients.
The MolDX Program, administered by Palmetto GBA, rigorously evaluates molecular tests for clinical utility, analytical validity, and medical necessity. The MolDX coverage decision signifies that LiquidHALLMARK® ctDNA/ctRNA liquid biopsy testing meets standards for Medicare coverage, and will promote broader access to this important tool.
Dr. Min-Han Tan, Founding CEO and Medical Director of Lucence, highlighted the importance of this achievement: “Securing a positive MolDX coverage decision will improve patient access to the LiquidHALLMARK® ctDNA/ctRNA liquid biopsy test, advancing availability of liquid biopsies beyond ctDNA-only tests. With this decision, we hope that more patients can benefit from advanced ctDNA/ctRNA testing.”
In a prospective multicenter study of 151 patients examining, among other things, non-inferiority of NSCLC G9 biomarker detection by LiquidHALLMARK versus a market competitor, an estimated 20% more (54 versus 45) actionable biomarkers were identified in 54 of 68 patients using LiquidHallmark ctDNA/ctRNA versus the ctDNA-only the market competitor [1].
The MolDx coverage decision positions Lucence as the only company in the USA with a combination (ctDNA and ctRNA) liquid biopsy test, with potential quantifiable Medicare reimbursement (USD 2,919) under code 0409U [2].
Lucence’s LiquidHALLMARK® tests are currently available at most private and public hospitals and clinics in the USA, Singapore, and Hong Kong.
[1] Samol et al. (2023 Dec 1-3). LiquidHallmark detects more tissue-confirmed guideline recommended biomarkers in lung cancer than Guardant360 in a prospective multicenter study [Poster]. 2023 North American Conference on Lung Cancer, Chicago, IL.
[2] DEX registry accessed on 16 December 2024.
About Lucence
Lucence is a precision oncology company focused on bringing clarity to cancer care. Our ultrasensitive liquid biopsy tests are based on proprietary AmpliMark™ sequencing technology and data analytics for earlier detection and effective treatment. Lucence operates twin CLIA-licensed, CAP-accredited laboratories in California and Singapore. For more information, visit www.lucence.com
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