SANTA CLARA, Calif., June 15 /PRNewswire/ -- Applied Imaging
(Nasdaq: AICX), a leading developer of cytogenetic systems for the diagnosis
of genetic disorders announced today that it received 510K clearance from the
U.S. Food and Drug Administration (FDA) to market its WINSCAN(TM) Automated
Imaging System for the identification and enumeration of nucleated red blood
cells from peripheral blood.
WINSCAN(TM) automatically scans slides made from peripheral blood and
locates and stores color images of the nucleated red blood cells in the
sample. The Company intends to incorporate WINSCAN(TM) into the upcoming
clinical trials of its proprietary method for the isolation and identification
of fetal nucleated red blood cells from the peripheral blood of pregnant
women.
Jack Goldstein, Ph.D., President and Chief Executive Officer of Applied
Imaging, stated, "This is our second FDA notification resulting from 510K
submissions made by the Company in late 1996 and 1997. It represents another
major milestone in our program to screen for genetic abnormalities by
isolating fetal cells from a routine maternal sample. This new test is being
developed to improve current prenatal screening by providing an accurate,
cost-effective procedure while reducing the risk of miscarriage associated
with invasive prenatal testing."
Applied Imaging Corporation, based in Santa Clara, Calif., develops
manufactures and markets automated clinical analysis systems used by
laboratories for the diagnosis of prenatal and other genetic disorders. The
company markets its products worldwide. Applied Imaging is developing a
proprietary prenatal test for screening of genetic abnormalities by isolating
fetal cells from a routing maternal sample. This new test is designed to
improve current prenatal screening techniques by providing an accurate and
cost effective procedure without the risk of miscarriage associated with
invasive prenatal testing.
The foregoing contains forward-looking statements within the meaning of
Section 27A of the Securities Act and Section 21E of the Securities Exchange
Act. Actual results could differ materially from those projected in the
forward-looking statements as a result of a number of factors, including the
failure of the Company to successfully develop or commercialize its prenatal
screening system, lack of regulatory approval, and the factors set forth in
"Risk Factors" in the Company's Form 10K for the year ended December 31, 1997,
as filed with the Securities and Exchange Commission.
Applied Imaging is a publicly traded company listed on the Nasdaq National
Market System under the symbol AICX.
SOURCE Applied Imaging Corp.
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CONTACT: Jack Goldstein, President and CEO, or Investor Relations, Mike Braden, 408-562-0250, both of Applied Imaging Corporation; or General Info, Ann Trunko, or Investor Contact, Kate Rajeck, 415-986-1591, both of the Financial Relations Board
NOTE TO EDITORS: For more information on Applied Imaging via fax at no cost, Dial 800-PRO-INFO, or 908-544-2850 outside U.S., ticker symbol is AICX
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