ChromaVision Completes Clinical Trials; Submits 510k to Expand Clinical Applications.

SAN JUAN CAPISTRANO, Calif.--(BW HealthWire)--Nov. 23, 1998-- ChromaVision Medical Systems Inc. (Nasdaq NM:CVSN), a leading cellular imaging diagnostics company and manufacturer of the Automated Cellular Imaging System (ACIS(TM)), Monday announced the successful conclusion of its international multi-center clinical study documenting the efficacy of its ACIS for use with the immunohistochemical (IHC) staining method.

Immunohistochemical stains are widely employed in slide-based tests used to diagnose or monitor numerous conditions including cancer and infectious disease. The study demonstrated the ability of the ACIS to enhance diagnostic accuracy and consistency for slide-based tests using the IHC staining method. The clearance of this 510(k) application would expand the spectrum of clinical tests that can be performed on the ACIS and enable development of many new tests. As an example, the IHC method of staining is used to determine overexpression of the HER2 protein, significant in guiding therapy with the newly approved drug for Breast Cancer, Herceptin(R), developed by Genentech (NYSE:GNE). The ACIS technology can provide an objective way of measuring the cutoff used to determine patients who would most benefit from this therapy. This filing represents a significant step toward accelerating commercialization of the ACIS as a multi-application platform.

Commenting on the results, ChromaVision Chief Science Officer Kenneth D. Bauer, Ph.D., said, "The clinical trials set out to show that the ACIS provides a clinically valuable tool for automated IHC analysis. Our results, in fact, reveal that ChromaVision's technology provides extraordinary sensitivity for the detection of extremely rare and clinically important cells. The findings indicate not only that the ACIS holds great potential to enhance the performance of an array of current laboratory assays, but may also serve a fundamental role in providing the technical base for highly sensitive and clinically significant future diagnostic applications."

According to ChromaVision Chief Executive Officer Douglas S. Harrington, M.D., "The results of the trials and the 510(k) application represent an important milestone in the commercialization of the ACIS as well as confirmation of the versatility and broad applicability of the technology. Our ACIS technology creates a new level of diagnostic accuracy to help physicians guide therapy for patients afflicted with life threatening or debilitating conditions."

Dr. Harrington continued, "The trials also yielded a number of discoveries which resulted in the filing of additional patents and caused us to expand the scope and length of the trial to document the value of these new technologies. Resulting enhancements to the ACIS include unparalleled improvements in sensitivity, reproducibility, and accuracy and establishment of new design guidelines which supersede the human standard."

ChromaVision's first 510(k) application received FDA clearance in June of 1997. This initial clearance involves the use of biochemical stains used with the ACIS to screen blood for certain malignancies, specifically, a certain form of leukemia.

About ChromaVision Medical Systems

ChromaVision Medical Systems manufactures and markets an advanced cellular imaging system designed to advance the detection, diagnosis, and treatment of cellular disease. The Automated Cellular Imaging System (ACIS) combines a proprietary, color-based imaging technology with automated microscopy to bring unprecedented sensitivity, accuracy and reproducibility to cancer, infectious disease and genetic cell-based diagnostics. ChromaVision currently markets its products to research centers, university medical centers and commercial laboratories throughout the world.

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

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.