DPC Receives FDA Approval for Marketing Total Immunoreactive PSA Assays for Prostate Cancer Detection.

Business Editors & Health/Medical Writers

LOS ANGELES--(BW HealthWire)--June 26, 2001

Diagnostic Products Corporation (NYSE:DP) today announced that it has received FDA approval to market four of its assays for prostate-specific antigen (PSA) -- IMMULITE PSA, IMMULITE 2000 PSA, IMMULITE Third Generation PSA, and IMMULITE 2000 Third Generation PSA -- with the indication of prostate cancer detection.

The assays are intended for in vitro diagnostic use with the IMMULITE and IMMULITE 2000 immunoassay analyzers for the quantitative measurement of PSA in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. They are further indicated as an adjunctive test to aid in the management of prostate cancer patients.

"We are gratified with the FDA approval that allows us to market our PSA assays for prostate cancer detection," said Michael Ziering, president and chief executive officer of DPC. "In the case of our Third Generation PSA assay, DPC can now meet all of our customers' requirements for a routine PSA assay with a single kit." The assay is available on both the IMMULITE and IMMULITE 2000 platforms.

"This highly sensitive assay is also the only clinically proven ultrasensitive PSA assay for the early detection of recurrent prostate cancer following radical prostatectomy. In addition, it is well suited for the routine monitoring of radiation- or hormone-treated patients. We also offer extended-range PSA assays for routine measurement on the IMMULITE and IMMULITE 2000 platforms for those who prefer them."

Correlation among the four assays is excellent.

The American Cancer Society has recommended that both a PSA blood test and a digital rectal examination be offered annually, beginning at age 50, to men who have at least a 10-year life expectancy, as well as to younger men who are at high risk. Patients should be given information regarding potential risks and benefits of early detection and treatment. Men in high-risk groups, such as those with two or more affected first-degree relatives, may consider screening at a younger age, perhaps 40 or 45.

DPC offers a total of 14 tumor markers on the IMMULITE and IMMULITE 2000 platforms, 10 of which have been approved by the U.S. FDA. This represents the broadest tumor marker menu of any in vitro diagnostics company.

For more information on the IMMULITE family of automated chemiluminescent immunoassay systems, call 800/372-1782, fax [phone], or e-mail [e-mail].

Founded in 1971, DPC is the global leader dedicated exclusively to immunodiagnostic testing. The company's product menu includes more than 400 tests to measure hormones, drugs and other medically important substances present at infinitesimal concentrations in body fluids and tissues. 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 domestically and in more than 100 countries worldwide. Additional company information can be found on the Corporate Web site at www.dpcweb.com.

Statements in this news release related to collaborative relationships, other aspects of product development, or that otherwise relate to future periods, are forward-looking statements within the meaning of Sections 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions that may not prove accurate. Actual results could differ materially from those anticipated due to risks inherent in the regulated market. These risks, including those related to the time or results of pending or uncertainties regarding the legal standards applicable to biotechnology patents, and actions by the U.S. Food and Drug Administration or the U.S. Patent and Trademark Office, are discussed in the company's most recent annual report on Form 10-K and in other SEC filings.