Indi (Integrated Diagnostics®), a company creating innovative molecular diagnostics and tools to effectively manage complicated diseases in a non-invasive manner, has published its latest results from a landmark clinical validation study in the Journal of Thoracic Oncology (JTO) titled “Validation of a Multi-Protein Plasma Classifier to Identify Benign Lung Nodules”. These data shows the company’s Xpresys Lung has the potentially to avoid excessive invasive testing for lung cancer.
Patients whose lung nodules are initially deemed likely to be benign are generally followed up by CT scans performed over a two-year interval. If the clinician’s initial evaluation of the patient’s nodules is found to be incorrect, then lung cancers are discovered early in the follow up period and can receive an adequate therapeutic intervention. However, if the initial diagnostic is more complicated, and the patient’s nodule is though to have an increased probability of being classified as lung cancer, a series of invasive biopsies or surgeries will follow. Nonetheless, many times the results identify nodules as benign or the procedures end up being non-diagnostic, which means that these patients undergo costly invasive procedures that are actually unnecessary.
Xpresys Lung is a clinical molecular blood test that can measure several different blood proteins, identifying lung nodules that have a high probability of being benign, thus reducing invasive diagnostic procedures’ associated risks.
The test includes 5 diagnostic proteins from different pathways related to lung cancer, along with 6 normalization proteins, and can quantify these proteins through a very sensitive technique, called multiple reaction monitoring mass spectroscopy (MRM-mass spec).
The results published online, demonstrate that Xpresys Lung has an 84 to 98% accuracy of detecting a benign lung nodule, and can individually assess every nodule with its own particular molecular signature. The research team used Xpresys Lung to preform a retrospective, multi-center analysis of 141 blood samples taken from patients (older than 40 years of age), who were found to have lung-nodules between 8 to 30 mm in diameter. Importantly, all samples derived from patients who had either benign nodules or early-stage non-small cell lung cancer (NSCLC), classified by nodule size, patient age, gender and clinical site. Importantly, these new results support earlier findings published in Science Translational Medicine.
“It is widely understood that a large percentage of patients with indeterminate lung nodules undergo unnecessary invasive testing due to the difficulty of diagnosing these nodules with current protocols,” Anil Vachani, M.D., assistant professor of medicine, University of Pennsylvania and lead author of the study said in a company’s press release. “This is the first clinical validation study of a non-invasive tool that physicians can use to aid diagnosis of these patients – who are often taken on a diagnostic odyssey that may include procedures such as lung biopsies and even surgery. The study results suggest this classifier may be an important new tool for pulmonologists seeking to identify which indeterminate nodules are benign.”
According to the 2013 American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice Guidelines, there is an extremely elevated rate (10-70%) of false negative biopsies of lung nodules, along with a false positive rate of 18-34% when surgeries are preformed. This means that an unacceptable number of patients undergo avoidable invasive procedures of lung nodules every year.
“Each year in the U.S. alone, approximately 3,000,000 people present with lung nodules; over a half a million fall into the indeterminate range,” Albert A. Luderer, Ph.D., chief executive officer, Indi, added in the press release. “Current estimates suggest the majority of these nodules turn out to be benign. Xpresys Lung is designed to reduce the risks and costs these patients face by allowing more pulmonologists to diagnose their patients as likely benign. Today’s research makes a strong case for expanded access to Xpresys Lung as a tool to help reduce over-treatment, lower costs and risks, and aid in reducing patient anxiety.”
“Strengths of the study include the use of independent samples from geographically dispersed centers with diverse patient populations, including two not participating in the classifier’s discovery studies,” concluded Pierre P. Massion, M.D., Ingram Professor of Cancer Research, Vanderbilt University Medical Center and one of the principle investigators of the study.