(PR NEWSWIRE) ChromaVision Granted 510K FDA Clearance To Market HER2 Breast Can
er Management Test
ChromaVision Granted 510K FDA Clearance To Market HER2 Breast Cancer Management
est
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), the leading provider of
automated cell-imaging systems and manufacturer of the ACIS(R) 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(R) (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.
About ChromaVision Medical Systems, Inc.
ChromaVision Medical Systems, Inc., based in San Juan Capistrano,
California, develops innovative medical systems to improve anatomic pathology
diagnostics through accuracy, standardization and quantitation.
ChromaVision's ACIS(R) (pronounced a-sis) or automated cellular imaging system
is a unique patented technology that detects, counts and classifies cells of
clinical interest based on color, size and shape to assist pathologists in
making critical medical decisions. Peer-reviewed clinical data and
publications have demonstrated that the ACIS digital microscope and
proprietary software can considerably improve accuracy and consistency over
other methods of laboratory testing. ChromaVision's mission is to improve the
quality and reduce the cost of patient care, and speed drug discovery. Many
of the top clinical laboratories, hospitals, university medical centers and
biopharmaceutical companies in the United States and Europe have adopted the
company's technology.
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, the performance and
acceptance of the Company's system in the market place, the Company's ability
to expand and maintain a successful sales and marketing organization,
continuation of favorable third party payer reimbursement for tests performed
using the Company's system, the ability to obtain additional financing for our
business on favorable terms or at all, unanticipated expenses or liabilities
or other adverse events affecting cash flow, uncertainty of success in
developing any new software applications, failure to obtain FDA clearance or
approval for particular applications, and dependence on third parties for
collaboration in developing new tests and in distributing the Company's
systems and tests performed on the system. Recent experience with respect to
ACIS placements, new contracts for placements, revenues and results of
operations may not be indicative of future results for the reasons set forth
above.
For further information, please contact: Investors, Matt Clawson of Allen
& Caron, Inc., +1-949-474-4300, for ChromaVision Medical Systems, Inc.;
or Stephen Dixon, Executive V.P., CFO of ChromaVision Medical Systems, Inc.,
+1-949-443-3355.
SOURCE ChromaVision Medical Systems, Inc.
-0- 12/30/2003
/CONTACT: Investors, Matt Clawson of Allen & Caron, Inc.,
+1-949-474-4300, for ChromaVision Medical Systems, Inc.; or Stephen Dixon,
Executive V.P., CFO of ChromaVision Medical Systems, Inc., +1-949-443-3355/
/Photo: NewsCom: newscom.com
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/Web site: chromavision.com /
(CVSN)
CO: ChromaVision Medical Systems, Inc.
ST: California
IN: HEA MTC BIO
SU: PDT
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