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Cleveland Clinic leading clinical program to improve early-stage lung cancer detection

November 27, 2007

Cleveland Clinic and Riverain Medical today announced the establishment of the first study in an ongoing program to determine whether chest X-ray CAD (computer-aided detection) can improve practical early detection of lung cancer. The program is designed to determine whether chest X-ray CAD can help identify hard to detect lung cancers at an early stage when they are most treatable, leading to improved patient survival rates.

The announcement of the clinical program was made at the 93rd Scientific Assembly and Annual Meeting of the Radiological Society of North America being held November 25-30, 2007, in Chicago, IL.

"Developing early detection methods is a key to improving trea™ent of lung cancer," said Micheal Phillips, M.D., Section Head of Imaging Sciences in Cleveland Clinic's Depar™ent of Diagnostic Radiology. "As it stands now, trea™ent options are limited because identifying malignant lung tumors in their early stage is so difficult."

The evaluation of X-Ray CAD is being funded by a grant from the State of Ohio. Moulay Meziane, M.D, is the principal investigator for the five-year study that will involve 9,000 test subjects. Investigators are currently conducting retrospective studies to evaluate the performance of the CAD system and the readers using it. The participants for the clinical trial will be enrolled in early 2008.

The Significance of Chest X-ray CAD (Computer Aided Detection)

Lung cancer kills more people in the United States annually than breast, prostate and colon cancers combined.* Eighty million chest X-rays are taken each year for a variety of reasons including persistent cough, routine physical exam, pre-operative preparation and many others. ♦ Chest X-rays are then viewed and analyzed by radiologists who provide an evaluation based on a visual assessment of the chest radiograph evaluation of the results. However, without chest X-ray CAD, many lung cancers may not be found or are overlooked when lung cancer is most treatable.

With chest X-ray CAD, the software "looks at" the X-ray, identifies regions of interest (actionable/suspicious pulmonary nodules), and circles them for further analysis. The radiologist is then able to review these suspicious areas more closely and determine whether additional follow-up, such as a CT scan, is needed for further evaluation/diagnosis. Chest X-ray CAD does not expose the patient to any additional radiation exposure or require any additional action by - or involvement of - the patient; CAD is applied by the radiologist after the chest X-ray is taken. CT scans or magnetic resonance imaging (MRI) are effective diagnostic follow-up methods for chest X-rays that have suspicious findings.

In previous clinical trials, Riverain's chest X-ray CAD technology helped radiologists identify16 percent more 9-15 mm solitary pulmonary nodules that were early stage (1A) lung cancer than the radiologist would have otherwise detected without CAD. OnGuard™ is the only FDA-PMA approved chest X-ray CAD product on the market.‡‡

"Unfortunately, most lung cancers are diagnosed too late for trea™ent to potentially save lives," said Sam Finkelstein, President of Riverain Medical. "We believe that OnGuard ™ can significantly improve clinicians' ability to identify lung cancers early and have a positive impact on the rate of patient survival which amazingly hasn't improved in over 40 years."

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