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Lucence, Veterans' Affairs Health Care System Launch Liquid Biopsy Screening Study

NEW YORK – Lucence and the VA Palo Alto Health Care System are launching a prospective observational study to evaluate the use of the sequencing-based LiquidHallmark liquid biopsy assay in a screening context.

The study will compare the sensitivity and specificity of positron emission tomography-computed tomography, or PET/CT, alone versus PET/CT in combination with LiquidHallmark in detecting lung cancer nodules between 6 and 20 millimeters in size, among high-risk patients with at least one lung nodule suspected of malignancy.

Secondary trial endpoints include measuring the sensitivity and specificity of ctDNA genotyping and of DNA methylation in detecting lung cancer.

"Lung cancer is more prevalent among veterans, but outcomes are better if cancer is detected earlier," Rajesh Shah, director of interventional radiology at the VA Palo Alto Health Care System and the study's principal investigator, said in a statement. "There is a significant unmet need for a cost-effective, noninvasive assay to better identify patients with lung cancer, especially among veterans."

At the American Society of Clinical Oncology annual virtual meeting earlier this year, Lucence presented data showing LiquidHallmark's utility in guiding treatment decisions for late-stage cancer and supporting the assay's expansion into non-small cell lung cancer.

The company also recently launched a US validation study of LiquidHallmark, testing its concordance with results obtained from conventional, tissue-based profiling. That study, named Liquik, is currently recruiting up to 200 adult participants with newly diagnosed, histologically confirmed, metastatic non-squamous NSCLC.

LiquidHallmark is currently available to oncologists in the US as a laboratory-developed test.