Lung nodules are a diagnostic challenge in the United States with an estimated yearly incidence of 1.6 million. There are significant costs, morbidity and mortality associated with the invasive biopsies needed to determine which nodules are cancerous.
“Integrated Diagnostics pioneered the liquid biopsy approach to lung nodules based on proteomic (protein) analyses of blood plasma samples from hundreds of patients with nodules,” stated CEO Dr. Albert Luderer. “This research resulted in the discovery of several lung cancer-associated changes in a patient’s plasma proteome.” The original findings were published in Science Translational Medicine and the Journal of Thoracic Oncology, and collectively demonstrated that specific protein changes could be detected in early stage lung cancer and utilized to exclude cancer in patients with benign nodules.
The newly clinical validation represents the performance of the second generation diagnostic test of Integrated Diagnostic’s original published work and is termed Xpresys Lung 2 (‘XL2’). The validation study confirmed the high accuracy of XL2 in identifying benign nodules in patients with a pretest probability of malignancy of 50% and less.
According to Co-authors Paul Kearney, PhD and Steven Springmeyer, MD, “to establish a high level of evidence, we conducted two prospective studies, one for discovery and the other for validation, that focused only on Stage 1A lung nodules. This is incredibly important as these are the lung nodules that are the hardest to assess. We integrated clinical risk factors and found that the proteomic signal was additive to the clinical risk factors. So in a real sense, XL2 is providing physicians with a molecular insight that they have never had before.”
“The outcomes of the PANOPTIC prospective, multi-center, observational trial are significant as they validate a new approach leveraging the proteome –– to accurately distinguish between benign and malignant nodules to rule out early stage lung cancer,” added senior author Dr. Peter Mazzone, MD, MPH, Cleveland Clinic, Director of the Lung Cancer Program and Lung Cancer Screening Program for the Respiratory Institute. “Through this large-scale research, we have shown that this may provide the needed objective assessment of lung nodules to better determine the best treatment path forward, which could reduce or avoid invasive biopsy or surgery procedures and create improved patient outcomes.”