SANTA CLARA, Calif., July 1 /PRNewswire/ -- Applied Imaging Corporation
(Nasdaq: AICX) announced today that it has submitted a 510(k) premarket
notification to the United States Food and Drug Administration (FDA) for its
Fetal Hemoglobin Identification kit. This kit is designed to identify red
blood cells containing fetal hemoglobin and to differentiate them from other
red blood cells.
"This submission represents another step forward in the detection and
identification of fetal red blood cells from a routine blood sample," said
Jack Goldstein, President and CEO of Applied Imaging.
Applied Imaging is engaged in an ongoing program to improve screening for
genetic and chromosomal disorders. "Currently, more than 2,300,000 prenatal
screening tests are performed in the U.S. each year," Goldstein continued.
"Despite the widespread use of prenatal screening, there are shortcomings
associated with existing methods. Invasive procedures, which include
amniocentesis, pose a risk of fetal loss of between 0.5 percent and 1.0
percent. Non-invasive blood chemistry tests, such as the triple test and the
alpha-fetoprotein test, result in a high number of false positives and have a
detection rate of approximately 60 percent. Applied Imaging's products under
development are intended to provide a more accurate, non-invasive method for
prenatal genetic screening that does not pose a risk to the fetus."
At the end of 1996, Applied Imaging submitted 510(k) notifications for its
hematological enrichment procedure and automated slide scanner. Both
applications are currently under review by the FDA.
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 prospectus dated November 7, 1996 as filed
with the Securities and Exchange Commission.
Applied Imaging Corporation develops, manufactures and markets automated
clinical analysis systems used by laboratories for the diagnosis of prenatal
and other genetic diseases. The Company markets its products worldwide and
has more than 500 customer sites in over 30 countries. Applied Imaging is a
publicly traded company listed on the Nasdaq National Market System under the
symbol AICX.
For more information on Applied Imaging via fax, please dial 800-PRO-INFO,
code AICX.
SOURCE Applied Imaging Corp.
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CONTACT: Donna Dickinson, Manager, Shareholder Services of Applied Imaging Corporation, 408-562-0250; or general information, Ann Trunko, or analysts, Kate Rajeck of Financial Relations Board, 415-986-1591, for Applied Imaging
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