Landmark Indi(R) Publication Shows Xpresys(R) Lung Helps Identify Benign Lung Nodules

SEATTLE, WA--(Marketwired - Jan 29, 2015) - Indi (Integrated Diagnostics®) today announced that the Journal of Thoracic Oncology (JTO) has published positive results from a landmark clinical validation study, which shows Xpresys Lung, a clinical laboratory-based molecular blood test service, helps identify benign lung nodules with high probability -- potentially helping avoid unnecessary invasive testing for lung cancer. The findings, published online, show 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. This result reproduces the performance demonstrated in earlier research published in Science Translational Medicine. In October the company announced managed care contracts providing 200 million covered lives with access to Xpresys Lung.

"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," said Anil Vachani, M.D., assistant professor of medicine, University of Pennsylvania and lead author of the study. "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."

The 2013 American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice Guidelines cite data showing that biopsies have a false negative rate of 10-70 percent -- and that surgeries have a false positive rate of 18-34 percent. These numbers suggest that tens of thousands of patients each year undergo unnecessary invasive procedures on benign nodules.

"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," said Albert A. Luderer, Ph.D., chief executive officer, Indi. "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."

The current study is a retrospective, multi-center analysis of 141 blood samples from patients 40 years or older with lung-nodules ranging from eight to 30 mm in diameter. Researchers used the classifier, Xpresys Lung, which comprises five diagnostic proteins from multiple pathways associated with lung cancer and six normalization proteins, in a blind analysis of these independent plasma samples. The test measures the relative abundance of these proteins using a highly sensitive analytic technique called multiple reaction monitoring mass spectroscopy (MRM-mass spec).

All study samples came from patients with either benign nodules or early-stage non-small cell lung cancer (NSCLC), matched for nodule size, age, gender and clinical site. The sample matching strategy yielded a classifier whose results are independent of a patient's age, smoking history, chronic obstructive pulmonary disease (COPD) diagnosis, or nodule size. Therefore the resulting classifier has the potential to complement each of these risk factors that are currently used in the clinical assessment of lung nodules.

"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," said Pierre P. Massion, M.D., Ingram Professor of Cancer Research, Vanderbilt University Medical Center and one of the principle investigators of the study.

The JTO paper is titled, "Validation of a Multi-Protein Plasma Classifier to Identify Benign Lung Nodules." Additional data from two studies supporting the technology behind Xpresys Lung were published in Science Translational Medicine on October 16, 2013. Click here to access the full study.

Current Procedure for Managing Lung Nodules

Each year millions of patients undergoing CT (computed tomography) scans are found to have pulmonary nodules. Patients whose 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 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.

In contrast, when physicians initially assess their patient's nodule to have a higher probability of lung cancer, they often undergo biopsies or surgeries to identify cancer. However, these invasive procedures often end up identifying the nodules as benign or turn out to be non-diagnostic, meaning that many patients may undergo costly, invasive procedures that turn out to be unnecessary.

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