Lucence has launched a validation study in the US for its amplicon-based LiquidHALLMARK liquid biopsy assay to identify biomarkers in lung cancer.

A next-generation sequencing (NGS) assay, LiquidHALLMARK is intended for ultrasensitive biomarker detection.

Leveraging AmpliMark’s sequencing technology, the assay assesses plasma circulating tumour deoxyribonucleic acid (DNA) mutations in 80 genes, including fusions in ten genes.

With a molecular barcode and error-correction technology, AmpliMark is meant to enhance the sensitivity of liquid biopsy test for single nucleotide variants and fusion genes.

Named ‘Liquid Biopsy for Detection of Actionable Genomic Biomarkers in Patients With Advanced Non-Small Cell Lung Cancer’ (LIQUIK), the validation study will compare LiquidHALLMARK against standard tissue-based biopsy.

The study plans to enrol 200 recently diagnosed metastatic non-squamous cell lung cancer (NSCLC) patients who are treatment-naive.

The primary endpoint of the study will compare LiquidHALLMARK to tissue NGS for mutation profile data in the participants having at least one out of EGFR, ALK, RET, ROS1, NTRK fusions, MET, BRAF, ERBB2 and KRAS genes identified through tissue biopsy.

LIQUIK has already enrolled the first subject and will continue to include more participants across seven sites in the country.

Lucence founding CEO Dr Min-Han Tan said: “The launch of our first prospective multi-centre study in the US brings us one step closer to advancing precision cancer care for the benefit of patients everywhere.

“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.”

Lucence noted that the assay offers a sensitivity of 99% at a detection limit of 0.1% variant allele frequency. It targets single nucleotide variants, insertions and deletions, copy number variations, microsatellite instability, fusions, and viruses.

Available as a laboratory-developed test to US oncologists, LiquidHALLMARK targets were detected in 15 cancers.

Liquid biopsy is an NCCN Guidelines-recommended method for testing NSCLC cases where tissue biopsy is not practicable.