SANTA CLARA, Calif., Jan. 13 /PRNewswire-FirstCall/ -- Applied Imaging
Corp. (Nasdaq: AICX) today announced that it has received 510(k) clearance
from the U.S. Food and Drug Administration (FDA) to market its Ariol(TM)
HerSight(TM) application to assist in detecting overexpression of the HER2
protein in breast cancer patients. This application utilizes Applied Imaging's
Ariol system to assist in the analysis of a complex test that is an important
factor in the evaluation and selection of certain breast cancer patients to
receive Genentech's Herceptin(R) (Trastuzumab) therapy. Herceptin is a
targeted therapeutic treatment indicated for women with metastatic breast
cancer whose tumors overexpress the HER2 protein.
Ariol Hersight, when used in conjunction with the DAKO HercepTest(R), is
now indicated for use in assessing breast cancer patients for whom Herceptin
therapy is being considered. Special testing is required to identify those
women who are HER2-positive and candidates for treatment with Herceptin. The
Ariol Hersight application aids physicians in determining whether the HER2
protein is over-expressed in breast cancer tissues that are being evaluated in
routine laboratory settings.
"We are very pleased to receive FDA clearance for our Ariol Hersight
application. This is an important validation of our work in developing
automated microscopy applications to assist pathologists in the interpretation
of complex cancer tests. Hersight and other Ariol applications under
development address the pressing clinical challenge of how best to assess
which breast cancer patients should receive a powerful targeted therapeutic
agent," commented Carl Hull, Chief Executive Officer of Applied Imaging.
"The Ariol system has been designed to bring our proprietary quantitative
immunomicroscopy technologies to bear on precisely these types of clinical
decisions. We will continue to develop new Ariol applications to meet the
needs of targeted therapeutics that are expected to be introduced in coming
years," added Hull.
According to the World Health Organization, there were over 1 million new
cases of breast cancer diagnosed worldwide during 2000. Breast cancer
accounted for 15% of all cancer deaths among women. The American Cancer
Society estimates that over 215,000 new cases of breast cancer will be
diagnosed in the United States during 2004 and that breast cancer will cause
the death of over 40,000 American women this year. HER2 protein overexpression
or gene amplification affects about 25% of breast cancer patients and results
in a more aggressive form of the disease.
NOTE: Herceptin(R) and HercepTest(R) are registered trademarks of
Genentech, Inc.
About Applied Imaging
Applied Imaging Corp., based in Santa Clara, California, is the leading
supplier of automated imaging systems utilized in genetics and pathology
laboratories throughout the world for the analysis of chromosomes in cancer
and prenatal disorders. The Company markets a range of imaging systems for
fluorescence and brightfield microscopy applications, including the Company's
Ariol(TM), MDS(TM), SPOT(TM), CytoVision(R), PowerGene(R) and QUIPS(R) product
lines. Applied Imaging has installed in excess of 3,000 systems in over 1,000
laboratories in more than 60 countries.
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, regarding, among other
matters, the outlook for the Company's Ariol HerSight application, the
development of additional applications for the Company's Ariol system and
possible submissions and clearances by the FDA. Forward-looking statements
address matters that are subject to a number of risks, uncertainties and other
factors, detailed in the Company's periodic filings with the Securities and
Exchange Commission including, but not limited to, those risks and
uncertainties listed in the section entitled "Management's Discussion and
Analysis of Financial Condition and Results of Operations - Factors Affecting
Future Results," in Applied Imaging's annual report on Form 10-K for the year
ended December 31, 2002. The forward-looking statements are made as of
January 13, 2004, and Applied Imaging is under no obligation to revise or
update the forward-looking statements.
For additional information on Applied Imaging, visit the Company's Web
site at http://www.aicorp.com .
SOURCE Applied Imaging Corp.
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Related links:
http://www.aicorp.com
CONTACT:
Barry Hotchkies, CFO of Applied Imaging
Corp., +1-408-562-0250; or Jocelyn Hunter of Financial Relations
Board, +1-415-248-3433, for Applied Imaging Corp.
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