DPC has received FDA approval to market four of its PSA assays for prostate cancer detection. IMMULITE^® PSA, IMMULITE^® 2000 PSA, IMMULITE Third Generation PSA, and IMMULITE 2000 Third Generation PSA are now approved for the quantitative measurement of serum PSA 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 also 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 CEO 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.” Published reports indicate that this assay has sensitivity suitable for the determination of PSA values encountered in early biochemical recurrence following radical prostatectomy, and in the low ranges of interest in treatment modalities such as intermittent androgen deprivation (IAD) therapy that are currently being investigated. (See the main article "DPC's Third Generation PSA Assay: The Clinician's Choice for PSA Testing.") In addition, it is well suited for monitoring radiation- or hormone-treated patients. DPC offers the IMMULITE PSA and IMMULITE 2000 PSA extended-range assays for those who prefer them for routine measurement.

These four DPC assays were used in the World Health Organization’s international collaborative study that established the first international standards for total (immunoreactive) and free PSA.²⁹ The assays are essentially equimolar for complexed (PSA-ACT) and free PSA, and show good correlation with each other.

DPC offers a total of 14 tumor marker assays on the IMMULITE and IMMULITE 2000 platforms, ten of which have been approved by the US FDA. This represents the broadest tumor marker menu available from any in vitro diagnostics company.

Reference

29. Rafferty B, Rigsby P, Rose M, Stamey T, Gaines Das R. Reference reagents for prostate-specific antigen (PSA): establishment of the first international standards for free PSA and PSA (90:10). Clin Chem 2000;46(9):1310-7.