Metabolomx test detects lung cancer from breath

Mountain View, CA – December 15, 2011 – Metabolomx, a diagnostic company focused on the detection of the metabolomics signature of cancer from exhaled breath, today announces publication of results from the first clinical study demonstrating a breath test that can both detect lung cancer and differentiate between types of lung cancer in humans. This seminal study, conducted at the Cleveland Clinic and led by Dr. Peter Mazzone, used Metabolomx' first-generation colorimetric sensor array, and reported accuracy exceeding 80% in lung cancer detection, comparable to computerized tomography (CT) scan. Further, the study found that Metabolomx' first-generation colorimetric sensor array could identify the subtype of lung cancer (small cell versus adenocarcinoma versus squamous cell) with accuracy approaching 90%.

The availability of a low-cost, non-invasive metabolomic breath signature for lung cancer is particularly timely given the recently announced results of the National Cancer Institute's National Lung Screening Trial (NLST) calling for wider CT screening of high-risk citizens. The breath signature, which reports active tumor metabolism, is thought to provide complementary information to CT, potentially helping clinicians distinguish benign from malignant lung nodules.

The sensor detects the unique pattern of volatile organic compounds (the "metabolic biosignature") present in exhaled breath. The article, "Exhaled Breath Analysis with a Colorimetric Sensor Array for the Identification and Characterization of Lung Cancer," is appearing in the current, online issue of the Journal of Thoracic Oncology (JTO), the official Journal of the International Association for the Study of Lung Cancer.

James R. Jett, MD, Pulmonary Medicine and Medical Oncology, National Jewish Health and Editor-in-Chief of the Journal of Thoracic Oncology, stated, "The JTO is dedicated to publishing the best in clinical research that may one day make a real difference in the care of patients. The currently reported results, should they be confirmed in additional clinical testing, provide a provocative challenge for us to look more closely at 'biosignatures,' as described in the journal article, that may be complementary to detection modalities such as CT scan. The advent of the NLST results demonstrating the value of CT heightens the need for non-invasive, low-cost companion diagnostics, and a metabolomic breath test, if born out in continuing studies, is a candidate to play that role in early lung cancer detection."

"The Cleveland Clinic results just published by the Journal of Thoracic Oncology, the reference journal for lung cancer, demonstrate the broad potential for use of breath analysis in the early detection of lung cancer," commented Paul Rhodes, PhD, Founder and CEO of Metabolomx. "These results show that the first generation of our breath test technology compares well with CT scans. Detection of the metabolomic signature of lung cancer in exhaled breath is non-invasive, rapid, and inexpensive, and will become a valuable adjunct to help assess an indeterminate CT, and may come to have a central role in early detection and differentiation of lung cancer, while lowering costs to the healthcare system."

The article was authored by Peter J. Mazzone, MD, MPH, Cleveland Clinic; Xiao-Feng Wang, PhD, Cleveland Clinic; Yaomin Xu, PhD, Cleveland Clinic; Tarek Mekhail, MD, MSc, Florida Hospital; Mary C. Beukemann, Cleveland Clinic; Jie Na, MS, Cleveland Clinic; Jonathan W. Kemling, PhD, University of Illinois, Chicago; Kenneth S. Suslick, PhD, University of Illinois, Chicago; and Madhu Sasidhar, MD, Cleveland Clinic. Initial results from this study were presented at the American College of Chest Physicians conference in November 2010.

Dr. Mazzone commented, "Our research shows that breath testing may help identify patients with lung cancer, as well as provide us with information that can help with treatment decisions, such as the type of lung cancer, its stage, and prognosis. The accuracy of these non-invasive tests can be further augmented when combined with existing clinical predictors, such as health status and age."

Metabolomx has begun trials of its next-generation sensor array system in an ongoing lung cancer study at the Cleveland Clinic. The Company expects their current generation system to be over 100 times more sensitive at detecting breath chemicals, which are often present in very low concentrations, than the system used in the published study.

The study, conducted at the Cleveland Clinic and led by Dr. Peter Mazzone, was designed to develop an exhaled breath biosignature of lung cancer using Metabolomx' colorimetric sensor array and to determine the accuracy of breath biosignatures of lung cancer characteristics with and without the inclusion of clinical risk factors. Breath samples were drawn from 229 individuals, 92 with biopsy-proven, untreated lung cancer and 137 either at a risk for developing lung cancer or with indeterminate lung nodules. Logistic prediction models were developed and statistically validated based on the color changes of the sensor. Age, sex, smoking history, and chronic obstructive pulmonary disease were incorporated in the prediction models.

• Approximately 81% accuracy for the detection of lung cancer without regard for subtype
• Approximately 83%, 85%, and 89% accuracy in discriminating patients with adenocarcinoma, squamous cell, and small cell lung cancer versus controls, demonstrating that the breath test can differentiate lung cancer subtype - the first diagnostic announced to do so.
• An ability to differentiate Stage I/II from Stage III/IV (approximately 79% accuracy) indicating the ability to identify lung cancer at the earliest stages.

Metabolomx has developed and owns all worldwide rights to the foremost breath test for cancer. By engaging some of the brightest minds in the fields of artificial and biological olfactory sensor arrays, neural processing and product development, Metabolomx has developed and tested an artificial olfactory sensor technology that recognizes the molecular fingerprint of the disease signature in breath. Metabolomx' technology is enabling the non-invasive, rapid, inexpensive and early diagnosis of lung cancer and other cancers. Metabolomx is located in Mountain View, CA. For additional information on the Company, please visit www.metabolomx.com.

Contacts

Media on behalf of Metabolomx
Justin Jackson
Michelle Szwarcberg
Burns McClellan
Tel: +1-212-213-0006
Email: jjackson@burnsmc.com
mszwarcberg@burnsmc.com