SOURCE: Integrated Diagnostics

Integrated Diagnostics

June 22, 2015 12:24 ET

Widespread Overtreatment of Benign Lung Nodules Seen in Landmark Chart Review Study

Biopsy and Surgery for Small Lung Nodules Is Often Unnecessary According to Study in CHEST

SEATTLE, WA--(Marketwired - Jun 22, 2015) - Indi (Integrated Diagnostics®) today announced CHEST has published a landmark chart review study, suggesting widespread overtreatment of benign lung nodules in the indeterminate range of 8 to 20 mm. The retrospective study of 377 patients sought to describe how pulmonologists typically manage these patients in their standard practice and to estimate the prevalence of cancer. The findings show a relatively low overall rate of cancer among these nodules (25 percent), but a high rate of invasive procedures. Thirty-five percent of the patients in the retrospective review who underwent surgery turned out to have benign nodules. Forty-four percent of patients initially deemed at low risk by some models for malignancy nevertheless underwent an invasive procedure -- suggesting that some pulmonologists may not be adhering to existing guidelines for managing nodules (ACCP guidelines suggest CT surveillance for patients deemed have less than 5% risk of cancer).

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 recent recommendation by the US Preventive Services Task Force (USPSTF) to screen high risk smokers and former smokers with annual CT scans.

"Indeterminate lung nodules (between 8 and 20 mm) are difficult to diagnose," said Gerard Silvestri, M.D., Hillenbrand Professor of thoracic oncology, Medical University of South Carolina, and one of the principal investigators of the study. "Typically, nodules smaller than those are treated conservatively, while larger ones are treated more aggressively. This is the first study of its kind to focus on this middle group. The results indicate there is significant variation in how lung nodules are managed. Further, when we went back and calculated the patients risk of having lung cancer at presentation, those in the low risk group had similar rates of surgery as those in high risk groups. We concluded that some patients with indeterminate lung nodules may be too aggressively treated."

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.

The retrospective study was funded by Indi, the maker of Xpresys Lung, a non-invasive, clinical laboratory-based, molecular blood test service designed to help physicians identify benign lung nodules with high probability. A separate, recent clinical validation study of the laboratory-developed test showed when the test indicates a nodule is likely benign, the result is correct between 84 and 98 percent of the time -- with each nodule receiving an individual score based on its molecular signature.

"The chart review study suggests many more patients should be put into 'watchful waiting,'" said Albert A. Luderer, Ph.D., chief executive officer, Indi. "Xpresys Lung is designed specifically to help pulmonologists evaluate whether to put more of their patients into watchful waiting with confidence. We believe doing so will reduce over-treatment, lower costs and risks, and lessen patient anxiety. Our hope is the use of Xpresys Lung will make it easier for pulmonologists to follow established clinical guidelines."

The chart review study is a multicenter, community-based chart review of patients aged 40 - 89 years with indeterminate pulmonary nodules presenting to 18 geographically representative outpatient pulmonary clinics across the U.S. Nodule size was restricted to 8 - 20 mm because management decisions in this size range are the most challenging.

"In the coming years, we are likely to see a significant rise in the number of indeterminate lung nodules due to new recommendations from the USPSTF to screen high risk individuals with annual low dose CT scans," said Nichole T. Tanner, MD, assistant professor, Medical University of South Carolina and lead author of the study. "My hope is this study will play an important role in raising awareness of the importance of managing these patients and those with incidentally detected nodules in closer accordance with established guidelines and ensure that only those patients with concerning findings are subjected to the risks associated with invasive procedures."

The paper is titled, "Management of Pulmonary Nodules by Community Pulmonologists: A Multicenter Observational Study."

Xpresys Lung is supported by a landmark clinical validation study published in The Journal of Thoracic Oncology in January 2015 and two studies published in Science Translational Medicine on October 2013. Click here to access the STM study.

About Indi

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, who recently received 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 Baird Capital, 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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