Diagnostic Products Corporation Released from FDA's Application Integrity Policy
07 September 2005 - 10:00PM
Business Wire
Diagnostic Products Corporation (NYSE:DP) reported that they have
received a letter from the U.S. Food and Drug Administration (FDA)
lifting the Application Integrity Policy (AIP). The original
restriction suspended the FDA's review of pending diagnostic test
applications DPC submitted and deferred scientific review of any
future submissions until the AIP issue was resolved. "We are very
happy to have this issue successfully resolved," stated Michael
Ziering, CEO of Diagnostic Products Corporation. About Diagnostic
Products Corporation Diagnostic Products Corporation, founded in
1971, is the global leader dedicated exclusively to
immunodiagnostics. DPC's product menu includes over 75 immunoassays
and more than 360 specific allergens and allergy panels. In
addition, DPC addresses the chemistry and laboratory automation
testing needs of its customers through partnerships with
manufacturers of chemistry systems and reagents. The combined
chemistry and immunoassay menu is one of the largest and most
diversified available, covering most laboratory tests requested.
DPC also designs and manufactures automated laboratory
instrumentation, which provides fast, accurate results while
reducing labor and reagent costs. DPC sells its products to
hospitals, clinics and laboratories in more than 100 countries.
Additional Company information can be found on DPC's website at
www.dpcweb.com. Except for the historical information contained
herein, this press release contains forward-looking statements that
involve risks and uncertainties that could cause actual results to
differ materially. These factors include the effects of
governmental or other actions relating to the FDA's decision that
its Application Integrity Policy should be applied to the Company
or relating to the Company's Chinese affiliate; the rate of
customer demand for the Company's products; the Company's ability
to successfully market new and existing products; its dependence on
certain suppliers; domestic and foreign government regulation; its
ability to keep abreast of technological innovations and to
translate them into new products; competition; political and
economic instability in certain markets including the movements of
foreign currencies relative to the dollar; and other risks and
uncertainties disclosed from time to time in the Company's SEC
reports and filings.
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