Study will examine the use of non-invasive liquid biopsy in combination with imaging tools for lung cancer screening in high risk patients
PALO ALTO, Calif. TK—In partnership with the VA Palo Alto Healthcare System, precision oncology company Lucence is launching its first early detection study in the US evaluating the use of its liquid biopsy technology in a screening context. The study, led by Rajesh Shah, MD of Stanford University, will test the feasibility of using non-invasive liquid biopsy in patients at high-risk for lung cancer as a screening tool in combination with positron emission tomography–computed tomography (PET/CT).
The prospective, observational study, Liquid Biopsy in Combination with PET/CT Versus PET/CT alone in Diagnosis of Small Lung Nodules will compare the sensitivity and specificity of PET/CT in combination with liquid biopsy in detecting lung cancer in nodules six to 20 millimeters in size compared to PET/CT alone. The study will enroll high risk patients who have at least one lung nodule deemed suspicious for cancer. Secondary endpoints include sensitivity and specificity of ctDNA genotyping and sensitivity and specificity of DNA methylation in detecting lung cancer. DNA methylation has emerged as a promising biomarker for early detection of lung cancer.
“Lung cancer is more prevalent among Veterans, but outcomes are better if cancer is detected earlier. There is a significant unmet need for a cost-effective, noninvasive assay to better identify patients with lung cancer, especially among Veterans,” said Dr. Rajesh Shah, MD, Director of Interventional Radiology and Associate Chief of Radiology at the VA Palo Alto Health Care System and the study’s Principal Investigator.
Lung cancer is the second most commonly diagnosed cancer and the most common cause of cancer-related deaths in the United States. Early detection of lung cancer has been shown to reduce mortality by 20%. The current standard of care for screening individuals at high risk of lung cancer is low dose computed tomography followed by additional invasive testing, such as percutaneous biopsy, bronchoscopy, or surgical procedure, if nodules are present. The expansion in early screening has led to an increase in patients with false positives who must then undergo uncomfortable and potentially complicating invasive tissue biopsies. A sensitive and specific non-invasive blood test for lung cancer screening could reduce costs and morbidity associated with unnecessary biopsy. This study is a significant step towards determining the feasibility of that approach on a large scale.
“A non-invasive liquid biopsy screening test that enables physicians to eliminate unnecessary invasive tests could both improve outcomes and the patient experience while reducing costs,” said Min-Han Tan, MBBS, PhD, Founding CEO of Lucence. “We are excited to initiate this study —the first study examining the use of Lucence’s AmpliMark technology for early detection of cancer in the United States—with the VA Palo Alto Healthcare System to continue to develop evidence for liquid biopsy’s utility across the patient journey. We are proud to be partnering with Dr. Shah and the VA Palo Alto to serve such an important population.”
Earlier this year, Lucence launched LIQUIK, Liquid Biopsy for Detection of Actionable Genomic Biomarkers in Patients With Advanced Non-Small Cell Lung Cancer, examining the use of the company’s amplicon-based LiquidHALLMARK® liquid biopsy assay versus tissue biopsy in detecting guideline-recommended biomarkers in lung cancer. LiquidHALLMARK is currently available to US oncologists as a laboratory developed test.