ChromaVision Medical Systems Inc. (CVSN) - 500 Beiträge pro Seite

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Chromavision Medical Systems, Inc. develops, manufactures and markets an automated digital microscope system with the ability to detect, count and classify cells based on color, size and shape to assist pathologists in making critical medical decisions that can affect patient treatment. The Company`s Automated Cellular Imaging System (ACIS) combines an automated microscope with computer-based color imaging technology originally developed for the United States government`s Star Wars program. The Food and Drug Administration (FDA)-cleared ACIS device is being used by pathologists and researchers to analyze specimens placed on slides and stained with color-producing, commercially available reagents. In addition to the ACIS system, Chromavision markets a modified ACIS pathology workstation primarily to community-based hospitals and pathology groups. The Company also offers service and maintenance to ACIS customers as part of the fee-per-use pricing structure.

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Revenues (Units in Thousands of U.S. Dollars $)

Quarter 2002 2003
Q1 1,791 2,853
Q2 2,194 2,854
Q3 2,609 3,079
Q4 2,661 --

Earnings Per Share (Units in U.S. Dollars $)

Quarter 2002 2003
Q1 -0.16 -0.06
Q2 -0.16 -0.06
Q3 -0.18 -0.06
Q4 -0.07 --

http://www.investor.reuters.com/IS.aspx?ticker=CVSN&target=%…
http://www.chromavision.com/

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ChromaVision Granted 510K FDA Clearance To Market HER2 Breast Cancer Management Test
Tuesday December 30, 7:30 am ET
Automated HER2 Test Aids Physicians in Determining Treatment for Individual Cancer Patients

SAN JUAN CAPISTRANO, Calif., Dec. 30 /PRNewswire-FirstCall/ -- ChromaVision Medical Systems, Inc. (Nasdaq: CVSN - News), the leading provider of automated cell-imaging systems and manufacturer of the ACIS® digital microscope system, announced today that the U.S. Food and Drug Administration (FDA) cleared for marketing the Company`s ACIS system to perform tests used to help physicians determine an appropriate course of treatment for breast cancer patients. The ACIS is the first imaging device cleared to detect, count, and classify the presence of the HER2 protein, allowing physicians a more precise and quantitative understanding of the specific traits of individual cancer tumors. Specifically, this FDA clearance allows ACIS to be used as a complement to the DakoCytomation HercepTest(TM) in the detection and measurement of Her2/neu (c-erbB-2). This measurement is critical in assessing breast cancer patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered.

There are over 200,000 new cases of breast cancer diagnosed each year in the U.S. A large percentage of ChromaVision`s customers have already conducted internal validation studies and routinely perform HER2 testing using ACIS. This specific clearance is intended to enable broadened marketing and promotional efforts and provide the Company with the ability to make specific claims as to the prognostic and predictive value of ACIS.

Michael G. Schneider, Executive Vice President and Chief Operating Officer of ChromaVision, said, "This clearance demonstrates the cooperative efforts of ChromaVision and the FDA in introducing new innovative technology to the pathology community. We believe we are the first image analysis company to receive this clearance and it marks a milestone in the acceptance of the ACIS. When combined with our previous clearance for ER/PR, HER2 completes a set of clearances for breast cancer tests that are performed on a routine basis.

"These test results help physicians decide how to manage and treat each individual patient and assist in the prediction of patient outcomes," Schneider added. "Data in this FDA submission substantiate the ability of our ACIS system to provide superior inter-pathologist and inter-laboratory standardization and accuracy over traditional assessment by manual microscopy."

The ChromaVision ACIS system can be applied to multiple existing laboratory diagnostic and prognostic tests and is designed to greatly enhance the precision and accuracy of the physician`s characterization of disease at the cellular level utilizing color. The ACIS combines proprietary, color-based imaging technology with automated, digital microscopy to increase detection sensitivity over existing manual testing methods.

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ChromaVision rockets, sector mixed

By Ted Griffith, CBS.MarketWatch.com
Last Update: 10:05 AM ET Dec. 30, 2003

BOSTON (CBS.MW) -- Shares of ChromaVision rocketed out ahead of other biotechnology stocks in early trading Tuesday after the small company said it won regulatory clearance for a breast cancer test.


ChromaVision (CVSN: news, chart, profile) shares soared $2.47, or 200 percent, to $3.70. ChromaVision said the FDA had approved the company`s ACIS system for use in the treatment of breast cancer patients. The test helps in measuring a protein known as HER2. Assessing levels of the HER2 protein is important in deciding whether a patient should be treated with Herceptin, a breast cancer therapy from Genentech (DNA: news, chart, profile).

Overall, biotech stocks were edging lower in early dealings. The Amex Biotechnology Index (BTK: news, chart, profile) dipped 0.5 percent, and the Nasdaq Biotechnology Index (NBI: news, chart, profile) nudged down 0.1 percent.