INDI® ANNOUNCES Xpresys® LUNG HAS POTENTIAL TO REDUCE UNNECESSARY SURGERIES BY 32% ACCORDING TO CLINICAL UTILITY STUDY PUBLISHED IN LUNG
SEATTLE, NOVEMBER 8, 2015 – Indi (Integrated Diagnostics®) a molecular diagnostics company pioneering the use of blood-based proteomic tests, today announced publication of a new clinical utility study in the journal LUNG suggesting Xpresys Lung has the potential to reduce unnecessary surgeries on indeterminate lung nodules by 32 percent. Xpresys Lung is a breakthrough, molecular diagnostic blood test designed to provide physicians with an objective tool to address a major medical dilemma—the management of indeterminate lung nodules.
The prospective-retrospective study of 475 patients from 12 geographically diverse sites in the United States sought to determine the ability of Xpresys Lung to assist physicians to better identify indeterminate lung nodules that are likely benign. Researchers prospectively collected blood samples from patients over age 40 with nodules size 8-30 mm, prior to a pathological diagnosis of benignity or cancer. Subsequently, each patient’s procedures and outcomes were compared with the result of their blood test. The analysis assumed each patient whose Xpresys test result was “likely benign” would not undergo surgery or other invasive testing. The results suggested use of the test would reduce unnecessary surgeries (on nodules that turned out to be benign) by 32 percent and invasive procedures by 31.8 percent.
“Diagnosing indeterminate lung nodules between 8 and 30 mm is difficult,” said Anil Vachani, M.D., associate professor of medicine, University of Pennsylvania and lead author of the study. “There is a need for non-invasive tools for assessing these nodules that are independent of traditional diagnostic tools such as age, smoking history and nodule size. This study suggests use of this particular blood test could reduce unnecessary surgeries and other invasive procedures, by allowing physicians to manage their patient’s nodules more conservatively.”
Conservative management of lung nodules – sometimes referred to as ‘watchful waiting’ – involves repeated CT scans over a two-year period to monitor the progress of patients whose nodules are initially deemed likely to be benign. If the clinician’s initial assessment of the patient's lung nodule is later found to be incorrect, then the cancers are usually discovered early in the follow up period and remain at an early enough stage for therapeutic intervention.
“This clinical utility study suggests widespread use of Xpresys Lung prior to the use of invasive procedures would allow many more patients to be put into ‘watchful waiting’,” said Albert A. Luderer, Ph.D., chief executive officer, Indi. “We believe doing so would significantly reduce the cost, risk, and patient anxiety associated with unnecessary treatment of benign nodules. Our hope is the use of Xpresys Lung will make it easier for pulmonologists to follow existing clinical guidelines and put more of their patients into watchful waiting.”
Estimates of the number of patients with pulmonary nodules range from 150,000 to one million per year in the U.S. alone – most of which turn out to be benign. The incidence of these nodules is likely to rise given the recommendation by the US Preventive Services Task Force (USPSTF) to screen high risk smokers and former smokers with annual CT scans.
The title of the paper in the journal LUNG is “Clinical Utility of a Plasma Protein Classifier for Indeterminate Lung Nodules.” Xpresys Lung is also supported by a chart review study published in CHEST in 2015; a clinical validation study published in The Journal of Thoracic Oncology in 2015; and two studies published in Science Translational Medicine in 2013. Xpresys Lung is offered as a clinical laboratory developed test out of Indi’s Seattle laboratory. The laboratory is certified by CLIA (The U.S. Clinical Laboratory Improvement Amendments) and the College of American Pathologists.
Indi (Integrated Diagnostics) is redefining molecular diagnostics and creating powerful new tools for physicians to non-invasively assess and more effectively manage complex diseases to improve patient outcomes, reduce complications, and lessen costs to the healthcare system. With the company’s first breakthrough test, Xpresys Lung, which measures multiple blood proteins and identifies lung nodules with a high probability of being benign, physicians have the potential to reduce risks and the need for unnecessary invasive procedures.
The company was co-founded in October 2009 by systems-biology pioneer Dr. Lee Hood, a recipient of the National Medal of Science from the U.S. government. His groundbreaking research is based on a systems biology approach, which measures hundreds of protein biomarkers found in blood to report on the physiological state of the body’s 50 major organs, such as the lungs.
Backers include Albany Capital, Alexandria Real Estate Equities, Baird Capital, CD-Venture GmbH, InterWest Partners, Life Sciences Alternative Financing and the Wellcome Trust. Foundational intellectual property is exclusively licensed from the Institute for Systems Biology and Caltech. Learn more at www.indidx.com
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