Indi(R) Announces Availability of Xpresys(TM) Lung Blood Test With Potential to Help Physicians Identify More Lung Nodules as Likely Benign and More Patients as Possible Candidates for Active Surveillance Instead of Invasive Procedures

SEATTLE, WA--(Marketwired - Oct 28, 2013) - Indi (Integrated Diagnostics), an emerging leader in molecular diagnostics, today announced the availability of Xpresys Lung, a protein expression blood test with the potential to help physicians diagnose more lung nodules as likely benign, thereby increasing the number of patients who can confidently choose serial CT scans of their nodules ("active surveillance"), instead of invasive procedures like surgery and biopsy, that carry significant risks and costs. As they developed the test, researchers at Indi followed an innovative strategy: Xpresys Lung is designed ONLY to assist physicians in identifying lung nodules likely to be benign, and is NOT intended to assist physicians with the identification of lung cancer.

The non-invasive blood test measures the relative abundance of proteins from multiple disease pathways associated with lung cancer, using a highly sensitive analytic technique called multiple reaction monitoring mass spectroscopy (MRM-mass spec). A retrospective validation study suggests that the test could allow physicians to recommend active surveillance to more of their patients. This laboratory-based analytical method offers objective molecular information about lung nodules (round lesions up to 30 mm) that physicians may use in addition to traditional independent predictors for assessing lung nodules (such as age, smoking history, nodule size and location). The test was designed to help physicians and their patients choose the most appropriate course of action based on a personalized assessment of their nodules using their Xpresys Lung test score in tandem with traditional assessment factors. Data from two studies supporting the technology behind Xpresys Lung were published in Science Translational Medicine (STM) on October 16, 2013.

"At Indi, our hope is that Xpresys Lung can provide objective molecular information about patients' lung nodules that will allow their physician to more frequently recommend serial CT scan follow-up, thereby avoiding costly and risky invasive procedures," said Kenneth C. Fang, M.D., chief medical officer, Indi and board certified pulmonologist. "Every year millions of patients have CT scans that find one or more lung nodules -- each one of these raises concern about cancer. Most turn out to be benign. But, identifying which nodules are at low probability for lung cancer is difficult. We believe Xpresys Lung may play an important role in reducing this diagnostic dilemma."

Xpresys Lung is intended for use with patients 40 years of age or older, who have lung nodules ranging from 8 - 30 mm in size. The test is intended to measure the relative abundance of 11 proteins across multiple lung cancer disease pathways such as inflammation, cell proliferation and cell death, to identify nodules that are likely benign. Retrospective validation data demonstrate that Xpresys Lung is not correlated with nodule size, smoking history or age -- the independent predictors traditionally used to assess the probability of lung cancer. That means the test provides complementary information that physicians may use in addition to existing diagnostic and probability assessment tools. The test identifies nodules as either "likely benign" or "indeterminate." When a patient's test score identifies their nodule as "likely benign" that result has been shown to correlate highly with clinical outcome according to a multi-center retrospective validation study (pending manuscript). The designation of "likely benign" suggests that the patient's physician may be able to recommend a course of active surveillance.

Active surveillance is a lung nodule management process that includes monitoring of a patient's nodules using CT scans at regular intervals, generally over the course of two years. Patients receive regular check-ups and typically only undergo more invasive procedures if their nodules grow. Among patients with nodules 8 - 30 mm in size, it is estimated that up to 80 percent turn out to be benign. Among patients with nodules who undergo surgical procedures, up to 34 percent end up with benign pathological findings¹. Those figures suggest that many patients receive procedures that may be unnecessary and that they may be better served by active surveillance.

"Instead of following the traditional diagnostic strategy of seeking to identify disease, the approach we took with Indi's first test is to help physicians identify patients whose lung nodules are likely to be benign," said Albert A. Luderer, Ph.D., chief executive officer, Indi. "We believe the identification of a protein blood signature that may help identify likely benign lung nodules is an important step in helping physicians and their patients avoid unnecessary diagnostic procedures -- thereby reducing costs, risks and the personal toll that comes with the diagnosis of a serious disease like lung cancer. Indi is dedicated to providing physicians and their patients with diagnostic tools that provide useful answers for managing complex diseases like lung cancer."

Validation Study Published in Science Translational Medicine (STM)

The STM paper described how researchers, in the process of developing the test, sought to assess the diagnostic power of 371 potential lung cancer biomarkers in millions of different combinations before settling on the diagnostic classifier (set of biomarkers) that their data indicated was most effective.

Indi researchers collected plasma samples from 143 patients from three sites to study the diagnostic value of various combinations of biomarkers. They came from patients with either benign nodules or Stage IA lung cancer, 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 or nodule size.

The group of proteins deemed to have the best performance was validated in a second study that utilized an independent set of 104 plasma samples (52 with cancer; 52 benign), including successful validation of the classifier at a completely new hospital site. As with the earlier study, each malignant sample was matched with a benign sample of the same age, gender, nodule size and participating clinical site. In this study, the classifier was found to have a high negative predictive value (NPV) -- meaning that patients whose test results identify protein markers at concentrations suggesting that their nodule is "likely benign" may have a high probability of that classification being correct. Subsequent unpublished validation studies have shown similar, high NPV scores, depending on the patient's test score.

About Indi

Indi (Integrated Diagnostics) is creating powerful new tools to help physicians manage complex diseases with a non-invasive blood test. The company's first test, Xpresys Lung, measures multiple blood proteins linked to pulmonary nodules. The aim of the test is to help physicians identify patients whose nodules are likely to be benign, eliminating the risks they face from biopsies and surgeries. www.IndiDx.com

The company, co-founded in October 2009 by systems-biology pioneer Dr. Lee Hood, is conceptually based on a systems view of disease where pathophysiology arises from disease-perturbed networks of proteins, genes, and other molecules. Investors include InterWest Partners and The Wellcome Trust. Foundational intellectual property is exclusively licensed from the Institute for Systems Biology and Caltech. Learn more at www.indidx.com

Reference:
1. Gould et al. Evaluation of Individuals With Pulmonary Nodules: When Is It Lung Cancer? Diagnosis and Management of Lung Cancer, 3rd ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. CHEST 2013; 143(5)(Suppl):e93S-e120S