SANTA CLARA, Calif., Dec. 18 /PRNewswire/ -- Applied Imaging
(Nasdaq: AICX), a leading developer of cytogenetic systems for the diagnosis
of chromosomal disorders, announced today that it has received notification
from the US Food and Drug Administration (FDA) that the company may market its
ENRICH Kit for use in the isolation of mononuclear cells from circulating
whole blood.
The Company intends to incorporate the ENRICH technology into its
proprietary method for the isolation of fetal nucleated red blood cells from
maternal peripheral blood in upcoming clinical trails. ENRICH is the
Company's first reagent resulting from its ongoing fetal cell detection
research programs.
"This is our first successful FDA notification resulting from a series of
three 510(k) submissions made by the company in late-1996 and 1997. It
represents a step forward in our program to screen for genetic abnormalities
by isolating fetal cells from a routine maternal blood sample," said Jack
Goldstein, Ph.D., President and Chief Executive Officer of Applied Imaging.
"This new test is being developed to improve current prenatal screening
techniques by providing an accurate and cost effective procedure while
reducing the risk of miscarriage associated with invasive prenatal testing,"
added Dr. Goldstein.
Applied Imaging Corporation 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 and
has installed approximately 1100 instruments in more than 500 customer sites
in over 30 countries.
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
failure to successfully develop the company's prenatal screening system,
receipt of FDA approvals for other components of such system, clinical
acceptance of such system, financial or other limitations and the factors set
forth in "Additional Risk Factors" in the Company's Form 10-K for the year
ended December 31, 1996, as filed with the Securities and Exchange Commission.
NOTE: For more information about Applied Imaging, visit the AICX web site
at http://www.aicorp.com.
SOURCE Applied Imaging Corp.
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Related links:
http://www.aicorp.com
CONTACT:
Carl W. Hull of Applied Imaging,
408-562-0250; or Paula Berg, general information, or Kate Rajeck,
analysts, of Financial Relations Board, 415-986-1591, for Applied
Imaging
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