SANTA CLARA, Calif., May 8 /PRNewswire/ --
Applied Imaging Corp. (Nasdaq: AICX) announced that it has filed a 510(k)
application with the U.S. Food and Drug Administration for its new
SlideScan(TM) system based upon its ability to detect micrometastic cells in
bone marrow specimens that have been identified using immunohistochemical
techniques. The SlideScan system is the clinical version of the company's
MDS(TM) image analysis platform.
Based on the results of extensive clinical evaluations conducted in the
U.S. and Europe, the Company has filed for clearance to market its system for
in vitro diagnostic use as an aid to pathologists in locating rare cells in
patient samples. "Our clinical trial examined the results achieved by skilled
pathologists using manual microscopic examination compared to our automated
scanning system," commented Jack Goldstein, Ph.D., Chairman & CEO. "The
results demonstrated that the Applied Imaging system is able to significantly
improve the detection of extremely rare and clinically important cells, thus
improving the accuracy of unaided pathologist diagnoses."
The company also announced the appointment of Diane C. Oates as Vice
President, Regulatory Affairs and Quality Systems. Ms. Oates has over
15 years of experience in a variety of regulatory affairs and quality
assurance roles and joins Applied Imaging most recently from Abaxis
Corporation, where she was the Vice President of Regulatory Affairs and
Quality Systems. Prior to Abaxis, Ms. Oates was with a number of leading
medical diagnostic firms, including Chiron Diagnostics, Ciba Corning and Syva
Company.
"We are delighted to have Diane join our team in this crucial quality
systems and regulatory role," said Carl Hull, President and Chief Operating
Officer. "Diane's extensive experience in clinical testing and regulatory
affairs will immediately benefit our product development efforts as we build
on the capabilities of our MDS image analysis platform for new applications in
oncology and genetic testing.
"We also look forward to Diane's contribution to the company's management
team as we further enhance the quality systems in our US and UK operations,"
added Hull. Ms. Oates earned her Bachelor's Degree in Biological Sciences at
San Francisco University and an MBA from Notre Dame.
Applied Imaging Corp., based in Santa Clara, California, is the leading
supplier of automated imaging systems utilized in cytogenetic and pathology
laboratories for the analysis of chromosomes in cancer and prenatal disorders.
The Company is expanding its efforts in scanning and imaging applications, as
well as providing key reagents, in the cancer pathology field. Applied
Imaging has installed over 1800 systems in 800 laboratories in more than
35 countries. Applied Imaging is a publicly traded company listed on the
NASDAQ Stock Market under the symbol AICX.
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, regarding, among other
matters, the Company's research and development and product development
efforts. Forward-looking statements address matters that are subject to a
number of risks and uncertainties, including the uncertainty of clinical
studies and regulatory approvals. Actual results could differ materially from
those projected in the forward-looking statement as a result of a number of
factors including the failure of the Company to successfully develop and
commercialize its micrometastasis or cytogenetic instrument businesses, and
other such factors as set forth in the Company's form 10-K for the year ended
December 31, 1999 as filed with the Securities and Exchange Commission.
For additional information on Applied Imaging via fax, please dial
1-800-PRO-INFO, (732-544-2850 outside of the U.S.), code AICX.
SOURCE Applied Imaging Corp.
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CONTACT: Carl Hull, President of Applied Imaging, 408-562-0250; or Joann Mahaffey, General Info, or Katharine Pearsall, Investor Contact, both of Financial Relations Board, 415-986-1591
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