SANTA CLARA, Calif., Nov. 15 /PRNewswire/ --
Applied Imaging Corp. (Nasdaq: AICX) announced the introduction of its
PathVysion(TM) Digital Scoring Application that provides the first automated
imaging capability to assist in detecting amplification of the Her-2/neu gene.
This application utilizes the Applied Imaging MDS(TM) system to automate the
analysis of a complex fluorescent assay that is an important factor in the
selection of certain breast cancer patients to receive Genentech's
Herceptin(R) therapy.
The PathVysion Application analyzes results of the PathVysion HER-2 DNA
Probe Kit developed by Vysis, Inc. to detect amplification of the Her-2/neu
gene in breast cancer tissue using fluorescence in-situ hybridization (FISH)
techniques.
"I am very pleased to announce that we have achieved another critical
milestone for the Company. Our PathVysion Application adds significant
capability to the range of applications available on our MDS system,"
commented Carl Hull, Applied Imaging CEO. "We are fulfilling an increasing
market demand for FISH-based tests. As one example of this demand, Genentech
announced in their third quarter analyst conference call that 18% of all tests
being run for Herceptin selection are now FISH-based compared to 5% a year
ago."
"A study in the current edition of the Cancer Control Journal indicates
that a consensus is emerging to support the use of both immunohistochemistry
(IHC) and FISH assays to determine whether Herceptin should be offered to
patients. We believe that our MDS system is the only imaging system on the
market capable of supporting the analysis of both IHC and FISH-based assays,"
continued Mr. Hull. "The PathVysion Application complements our release
earlier this year of a suite of key breast cancer applications that aid
pathologists with the interpretation of various IHC assays."
The PathVysion Application introduced today is being released to clinical
and research sites for research use, pending application to the Food and Drug
Administration for full clearance of the application for routine clinical use.
NOTE: PathVysion is a trademark of Vysis, Inc. used under license by
Applied Imaging Corp. Herceptin is a registered trademark 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 for the analysis of chromosomes in cancer and prenatal disorders.
The Company is expanding its efforts in scanning and imaging applications in
the cancer pathology field. Applied Imaging has installed over 2,000 systems
in 1,000 laboratories in more than 35 countries. The Company markets a range
of clinical and research imaging systems for fluorescence and brightfield
microscopy analysis, including the Company's MDS(TM), CytoVision(R),
PowerGene(R) and QUIPS(R) product lines.
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, regarding, among other
matters, the submission and clearance of applications to the Food and Drug
Administration for the applications discussed in this Press Release and the
continued acceptance of the MDS(TM) system. Forward-looking statements
address matters that are subject to a number of risks and uncertainties that
could cause actual results to differ materially, including the uncertainty of
future sales performance and other factors as are set forth in the Company's
form 10-K for the year ended December 31, 2000 as filed with the Securities
and Exchange Commission.
For additional information on Applied Imaging via fax, please dial
800-PRO-INFO, (732-544-2850 outside of the U.S.), code AICX, or visit the
Company's web site at http://www.aicorp.com.
SOURCE Applied Imaging Corporation
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Related links:
http://www.aicorp.com
CONTACT:
Barry Hotchkies, CFO of Applied Imaging
Corporation, +1-408-562-0250; or Investors/Media, Liz Saghi, or
General, Pam Roberts, +1-415-986-1591, both of FRB/Weber
Shandwick, for Applied Imaging Corporation
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