SANTA CLARA, Calif., March 24 /PRNewswire-FirstCall/ -- Applied Imaging
Corp. (Nasdaq: AICX) today announced that it has received 510(k) clearance
from the U.S. Food & Drug Administration (FDA) to market its automated
applications for Estrogen Receptor (ER) and Progesterone Receptor (PR)
analysis in breast cancer patients. These applications utilize Applied
Imaging's Ariol(TM) system to assist in the analysis of tests that are
important factors in the selection of certain breast cancer patients to
receive hormonal therapies such as Tamoxifen. Along with the previously
cleared Her-2/neu application, ER and PR comprise the most commonly used panel
of immunohistochemistry tests for breast cancer assessment in the clinical
pathology laboratory.
The ER and PR results are used as an aid in the management, prognosis and
prediction of therapy outcomes for breast cancer patients. ER and PR are
hormone receptors found in cancer cells and are two examples of the clinical
importance of biomarkers in the assessment of cancer patient status. Unlike
normal breast cells, cancer cells arising in the breast do not always have
receptors for estrogen. Breast cancers that have estrogen receptors are said
to be "estrogen receptor-positive," with cancer cell growth under the control
of estrogen. Such cancers are often susceptible to treatment with the drug
tamoxifen, because tamoxifen works by blocking the interaction between
estrogen and the estrogen receptor.
"We are very pleased to receive additional FDA clearances for our Ariol
system. This is validation of our work in developing automated microscopy
applications to assist pathologists in the interpretation of complex cancer
tests. FDA clearances for applications such as ER and PR hormone receptors for
breast cancer are important to our success in the clinical pathology market,"
commented Carl Hull, Chief Executive Officer of Applied Imaging.
"The Ariol system provides automated imaging solutions to assist the
pathologist and oncologist in assessing tests that are important in helping to
select breast cancer patients to receive specific targeted therapeutic agents.
We anticipate the development of additional Ariol applications designed to
meet the requirements of future biomarkers as they are transitioned from
research and drug discovery into the clinical lab environment," continued
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.
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 ER and PR applications, our ability to
succeed in the clinical pathology market, the future development of additional
applications for the Company's Ariol system and possible submissions to 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 March 24, 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 website
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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