NEW YORK – Precision oncology company Lucence said Tuesday that it has begun the first US validation study of its sequencing-based LiquidHallmark liquid biopsy assay versus tissue biopsy in detecting guideline-recommended biomarkers in lung cancer.
The multicenter prospective trial will enroll 200 treatment-naive newly diagnosed metastatic non-squamous non-small cell lung cancer patients and will assess the concordance of LiquidHallmark with conventional tissue-based profiling for nine clinically relevant genes — EGFR, ALK, RET, ROS1, NTRK fusions, MET, BRAF, ERBB2 and KRAS.
Lucence's assay uses an amplicon-based next-generation sequencing technology called AmpliMark. The test is designed to detect mutations in plasma circulating tumor DNA — single nucleotide variants (including cis-trans), insertions and deletions, copy number variations, microsatellite instability, and fusions — across 80 genes. It also detects virus-associated DNA sequences. According to the company, LiquidHallmark has demonstrated 99 percent sensitivity at a detection limit of 0.1 percent variant allele frequency for certain specific variants.
Lucence said the study has enrolled its first patient and will continue enrollment across seven study sites nationwide.
"Building evidence to support the clinical utility and sensitivity of our test will enable us to make LiquidHallmark's high-resolution, target-rich insights more widely available to patients across the country," CEO Min-Han Tan said in a statement.
The firm's Palo Alto laboratory received CLIA certification late last year, and its assay is currently available to US oncologists as a laboratory-developed test.