Lucence has announced that its LiquidHALLMARK® ctDNA/ctRNA liquid biopsy test has received Medicare coverage approval through the Molecular Diagnostic Services (MolDX) program. Effective from October 2024, the decision establishes the test as a reimbursable diagnostic tool for personalised cancer care in the United States.
- Clinical Advantage: By combining circulating tumour DNA (ctDNA) and RNA (ctRNA), the test identifies approximately 20% more actionable biomarkers than ctDNA-only alternatives. In a prospective study of lung cancer patients, the dual-modality approach detected 54 actionable biomarkers compared to 45 by a leading competitor.
- Market Position: Lucence is currently the only provider in the US offering a combined ctDNA and ctRNA liquid biopsy with a dedicated Medicare reimbursement rate, set at USD 2,919 under code 0409U.
- Accessibility: The test is now available across a broad network of public and private healthcare facilities in the USA, Singapore, and Hong Kong, supporting minimally invasive genomic profiling.
This summary is based on a press release issued by Lucence.