1. What is OnGuard?

a. OnGuard is a computer-aided detection, software solution for the detection of solitary pulmonary nodules from 9 to 30mm.

 2. How does OnGuard work?

a. The OnGuard uses a sophisticated algorithm that works by analyzing a chest X-ray for regions that resemble solitary pulmonary nodules. To accomplish this, OnGuard detects and segments objects it considers to be candidate nodules. OnGuard analyzes the objects by computing features (measurements) to characterize each of the candidate regions. Regions with descriptions with attributes are similar to a solitary pulmonary nodule are marked with a circle as regions of interest by the software.

3. What do you mean when you say “Pattern Recognition”?

a. Pattern recognition is a discipline of the information sciences. It combines engineering, mathematics, statistics and computer science disciplines along with computer science to analyze patterns. Patterns constitute regularities – predictable behavior – within data. In the context of OnGuard, we seek to detect patterns indicative of solitary pulmonary nodules within the chest X-ray images.

4. What is the clinical benefit?

a. A multi-reader, multi-case study was conducted by researchers at Georgetown University as part of the FDA-PMA approval process. The independent set of images used for the study contained normal cases and truth confirmed cancer. The study demonstrated that a reader aided with OnGuard was statistically superior to the unaided reader using the area under the localized receiver operating characteristic curve.

i. OnGuard 5.1 Reader Study for FDA PMA Approval 2009

b. The clinical benefits are an increase in the nodule detection rate due to a reduction in oversight errors. Studies have shown the use of OnGuard can result in as much as 30 - 50% improvement in detection rates of missed cancers.

i. Li F, Engelmann R, Metz CE et al: Lung Cancers Missed on Chest Radiographs: Results Obtained with a Commercial Computer-aided Detection Program. Radiology: Volume 246: Number 1, January 2008.

ii. White CS, Flukinger T, Jeudy J, and Chen JJ. Use of a Computer Aided Detection System to Detect Missed Lung Cancer at Chest Radiography Radiology 252, 2009.

5. Is OnGuard on a dedicated review station?

a. No, the OnGuard image is stored as part of the original patient study and is available immediately available for review on the existing PACS review station with the original study.

 6. Will it work with my PACS? Will it work with all PACS?

a. OnGuard is fully DICOM compliant and will work on all PACS systems.

 7. How does OnGuard affect workflow?

a. Individual results vary, and speed increases as one becomes accustomed to reading with OnGuard. Generally, we would anticipate that CAD requires only a few additional seconds.

 8. Where is OnGuard available for sale?

a. OnGuard 5.1 is available in U.S., Canada, and EU.