Prostate CancerMore Choices in PSA Tests

Each year almost 700,000 new cases of prostate cancer are diagnosed worldwide, and approximately 221,000 deaths occur annually due to prostate cancer. Siemens Healthcare Diagnostics offers a full menu of Prostate Specific Antigen (PSA) tests that aid in the detection, monitoring and management of prostate cancer. In addition to traditional PSA tests, the Siemens portfolio of PSA assays includes unique Complexed PSA and Third Generation PSA assays that are alternatives to conventional testing.

Laboratorians

Siemens can equip your cancer center, hospital, or reference laboratory with the full menu of in vitro PSA tests demanded by today’s healthcare professionals, including Complexed PSA and 3rd Generation PSA assays that are alternatives to traditional PSA tests. The Siemens portfolio of PSA assays provides your healthcare clients with more choices to aid in prostate cancer detection, monitoring, and follow-up.

The Siemens Portfolio of PSA Assays

PSA tests run on ADVIA Centaur^®, IMMULITE^® and Dimension^® systems ensure cost-effectiveness and fast turnaround times.

ADVIA Centaur CP	ADVIA Centaur XP	IMMULITE 2000XPi	Dimension EXL™ with LOCI^®	Dimension Vista^®	Dimension^® Rxl Max^® / Xpand^® Plus
PSA	PSA	PSA	PSA	PSA	PSA
fPSA¹	fPSA¹	fPSA	fPSA	fPSA	fPSA
Complexed PSA	Complexed PSA	-	-	-	-

Product availability may vary from country to country and is subject to varying regulatory requirements.

1. Under development. Not available for sale.

PSA Test

PSA testing is clinically accepted by the NACB and EGTM for both detection and monitoring.¹

Quantitatively measures prostate specific antigen in serum
Classic screening method to aid in the detection of prostate cancer
Used in conjunction with a digital rectal examination (DRE)

3rd Generation PSA Test²

Our 3rd Generation PSA assay aids in the detection of prostate cancer and is used as an adjunctive test to aid in the management of prostate cancer patients.

Provides information on possible relapse in facilitating patient management
Provides an early indication of disease status after treatment when used in conjunction with other clinical information³
Approved for prostate cancer detection in conjunction with a digital rectal examination (DRE)

Free PSA Test

Our fPSA assay helps guide decision-making in men aged 50 years or older who have DRE findings not suspicious of cancer who are in the diagnostic gray zone (4.0–10 ng/mL).

Percent free PSA assessment may help to reduce unnecessary biopsies^4,5
It helps to differentiate cancer from benign prostatic hyperplasia
Percent free PSA is lower in prostate cancer than in benign prostate hyperplasia4,5

Complexed PSA Test

The Siemens proprietary Complexed PSA is an alternative to traditional PSA testing for frontline detection.

PSA complexed with alpha-1-antichymotrypsin (ACT) comprises a higher proportion of PSA in men with prostate cancer^6-8
It is recommended as a frontline detection test
It is used in conjunction with a digital rectal examination (DRE)

Assay Ranges and Performance Characteristics

System	Assay	Reportable Range
ADVIA Centaur CP/XP	PSA	0.01 ng/mL - 100 ng/mL
	Complexed PSA	0.03 ng/mL - 100 ng/mL
	FPSA*	0.01 ng/mL - 25 ng/mL
IMMULITE 2000/2000 XPi	PSA	0.04 ng/mL - 150 ng/mL
	FPSA	0.07 ng/mL - 25 ng/mL
	3rd Generation PSA**	0.005 ng/mL - 20 ng/mL
Dimension RxL Max^®/Xpand^® Plus/EXL™	PSA	0.13 ng/mL - 100 ng/mL
	FPSA	0.06 ng/mL - 45 ng/mL
Dimension Vista^®	PSA	0.010 ng/mL - 100 ng/mL
	FPSA	0.015 ng/mL - 20 ng/mL

* Under development. Not available for sale on the ADVIA Centaur CP

** 3rd Generation PSA not available on the IMMULITE 2000/2000 XPi Systems

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Education & Training

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NACB Laboratory Medicine Practice Guidelines. Use of Tumor Markers in Testicular, Prostate, Colorectal, Breast and Ovarian Cancers. 2009.

The IMMULITE Third Generation PSA assay has not been evaluated and approved by the FDA for use with the IMMULITE Free PSA assay in the percent free PSA calculations.

Shen, et al. Ultrasensitive serum prostate specific antigen nadir accurately predicts the risk of early relapse after radical prostatectomy. J of Urol 2005; 173; 777-780.

Catalona WJ, Partin AW, Slawin KM, Brawer MK, Flanigan RC, Patel A, Richie JP, deKernion JB, Walsh PC, Scardino PT, Lange PH, Subong EN, Parson RE, Gasior GH, Loveland KG, Southwick PC. Use of the percentage of free prostate-specific antigen to enhance differentiation of prostate cancer from benign prostatic disease: a prospective multicenter clinical trial. JAMA. 1998 May 20;279(19):1542-7.

Lilja, et al. Significance of different molecular forms of serum PSA. Urol C Clin North Am 1993; 20:681:686.

Brawer MK, Cheli CD, Neaman IE, Goldblatt J, Smith C, Schwartz MK, Bruzek D J,Morris DL, Sokoll LJ, Chan DW, Yeung KK, Partin AW, Allard WJ. Complexed prostate specific antigen provides significant enhancement of specificity compared with total prostate specific antigen for detecting prostate cancer. J Urol. 2000 Nov;164(5):1671-2.

Lilja H, Christtensson A, Matikainen M-T, et al. Prostate-specific antigen occurs predominantly in complex alpha-1-antichymotrypsin. Clin Chem 1991 ; 7 :1618-25.

Stenman UH, Leinonen J, Alfthan H, et al. A complex between prostate-specific antigen and alpha-1-antichymotrypsin is the major form of prostate-specific antigen in serum of patients with prostatic cancer: Assay of the complex improves clinical sensitivity for cancer. Cancer Res 1991; 51: 222-6.