Breakthrough Device to Assist in Detection of Cancer and Infectious Disease Cleared By FDA.

SAN JUAN CAPISTRANO, Calif.--(BUSINESS WIRE)--July 29, 1999--

Automated Cellular Imaging System (ACIS(tm)) from ChromaVision

300 Percent More Sensitive than Existing Testing Methods

Potential to Aid in Earlier Disease Detection and Significantly

Improve Millions of Diagnostic Tests Performed Annually

ChromaVision Medical Systems Inc. (Nasdaq NM:CVSN) Thursday announced that the U.S. Food and Drug Administration (FDA) cleared for marketing a powerful new tool that may help physicians detect cancer, infectious diseases and genetic conditions earlier and more accurately, potentially leading to improved patient treatment.

The ACIS system from ChromaVision, which can be applied to a vast number of existing laboratory diagnostic tests, is designed to greatly enhance a physician's ability to detect disease at the cellular level utilizing color. The ACIS combines proprietary, color-based imaging technology with automated microscopy to increase detection sensitivity more than 300 percent over existing manual testing methods.

The FDA clearance obtained is for use of the ChromaVision Automated Cellular Imaging System, or ACIS(tm), with a widely used staining method called immunohistochemistry (IHC). Immunohistochemistry is commonly used in the evaluation of numerous disease conditions. This single clearance enables the commercialization of five ACIS tests scheduled for release in 1999 and paves the way for rapid introduction of future ACIS tests.

"While pathologists are accurate in many situations in detecting cancerous or diseased cells, the human eye is subject to significant limitations. Specifically with the detection of rare tumor cells or micrometastases, pathologists may underestimate or miss entirely cancer cells that can be detected by a system like the ACIS," says Dr. Michael F. Press, M.D., Ph.D., Professor, Department of Pathology, University of Southern California, Kenneth Norris Jr. Comprehensive Cancer Center. "The ability of the ACIS system to detect suspected tumor cells in remote areas of the body at a relatively early stage allows specific patient treatment, resulting in a lower chance of disease reoccurrence and ultimately, a better chance of survival."

Used in conjunction with the IHC class of stains, the ACIS system is able to "red flag" abnormal cells, by detecting acute color differences. This enhanced sensitivity enables the system to detect one abnormal cell among 100 million normal cells in a specific application that identifies suspected tumor cells. In a clinical study designed to diagnose the presence of cancer micrometastases in bone marrow, 44 percent of the slides initially called negative by traditional manual review were correctly identified as positive by a pathologist using the ACIS. The review of the slides with the ACIS system resulted in a 300 percent increase in sensitivity to detect tumor cells over traditional manual methods. Results from related studies performed in the trial demonstrated 100 percent accuracy for pathologists using the ACIS to identify tumor cells in bone marrow samples.

More than one billion slide-based diagnostic procedures are performed in the U.S. each year. Currently, pathologists manually compare samples of human cells or tissue for characteristic patterns or color variations that suggest the presence of disease. While the human eye is superb at pattern recognition, it is limited in distinguishing subtle variations in color. As a result, some lab tests are highly subjective and results may vary depending upon who interprets the test, potentially leading to inaccurate positive or negative conclusions.

Using color as the primary means of analyzing samples, the ACIS helps the pathologist achieve an unprecedented level of accuracy and objectivity in the detection of disease at the cellular level. For example, when reading a test to measure the overexpression of the HER2 protein in breast cancer patients, the pathologist is challenged to quantify the level of brown stain present in a tissue sample from the patient. The ACIS system has the ability to discriminate and reliably score 255 levels of color intensity versus only 4 color levels detectable by the human eye. Quantification of the HER2 protein is used to determine which patients would most benefit by treatment with a newly approved therapeutic drug, Herceptin(R), developed by Genentech (NYSE:DNA). Current manual visual assessment of the overexpression of the HER2 protein is semi-quantitative and subject to interpretation.

ChromaVision tests scheduled for release this year include the detection of cancer micrometastases in bone marrow and sentinel lymph nodes, HER2 protein expression, and estrogen and progesterone receptors in breast cancer patients and Cytomegalovirus antigenemia, a common virus that can cause life-threatening disease in immune-compromised patients.

"As a pathologist, I have devoted my career to increasing the accuracy of laboratory diagnostics to guide therapy in critical clinical decisions," commented Douglas S. Harrington, M.D., CEO and President of ChromaVision. "I am confident the ACIS system has the potential to assist the pathologist in virtually all areas of diagnostic medicine where slide-based tests are used to guide therapy. Color is used in some form in all slide-based testing to identify cells of interest. This creates an extremely broad pipeline of tests for ChromaVision."

This is the second FDA clearance for ChromaVision. The first 510(k) clearance was obtained in July of 1997 for an application used to screen blood for certain types of malignancies.

About ChromaVision Medical Systems

ChromaVision Medical Systems manufactures and markets an advanced cellular imaging system designed to improve the detection, diagnosis and treatment of cellular disease. ChromaVision currently markets its products to physicians and researchers in university medical centers and commercial laboratories throughout the world.

ChromaVision Medical Systems Inc. (Nasdaq NM:CVSN) is a Safeguard Scientifics, Inc. (NYSE:SFE) partnership company and was originally formed by XL Vision, Inc.

For more information on ChromaVision Medical Systems, Inc., please visit the Company's web site at http://www.chromavision.com.

The statements contained herein regarding ChromaVision Medical Systems Inc. contain forward-looking statements that involve risks and uncertainty. Future events and the Company's actual results could differ materially from the results reflected in these forward-looking statements. Factors that might cause such a difference include, but are not limited to, uncertainty of success in developing any new diagnostic test, failure to obtain FDA clearance or approval for particular applications and dependence on third parties for clinical testing.

ACIS is a Trademark of ChromaVision Medical Systems Inc.