Prostate cancer diagnostic solutions

Prostate cancer is a major public health concern. Prostate cancer is the fourth most common cancer in both sexes combined and the second most common cancer in men1. Approximately 1 man in 7 will be diagnosed with prostate cancer in his lifetime2. Approximately 70% of prostate cancer cases are low risk, yet up to 90% are treated aggressively.3

We offer a wide menu of immunohistochemistry (IHC) assays.  Our portfolio of products delivers the high sensitivity and specificity you need.

Our antibodies are ready to use on the fully automated VENTANA BenchMark IHC/ISH staining platforms, reducing the time-to-result and resources required with manual or semi-automated solutions. We have a robust assay development program focusing on immunohistochemical staining, clinical reagents, cancer diagnostic assays, and much more.

Immunohistochemical staining with Basal Cell Cocktail 34ßE12 + p63
Basal Cell Cocktail (34ßE12 + p63)

VENTANA Basal Cell Cocktail (34βE12+p63) is an antibody cocktail of p63 (4A4) and keratin (34βE12). It may be used to aid in the differentiation of benign lesions with basal cells from malignant prostate lesions lacking basal cells. For more than 15 years, basal cells have been the immunohistochemical cornerstone in the diagnosis of prostate cancer4,5

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Immunohistochemical staining with Basal Cell Cocktail 34ßE12 + p63
p504s (SP116) Rabbit Monoclonal Primary Antibody

p504s (SP116) Rabbit Monoclonal Primary Antibody is directed against the p504s enzyme (also known as alpha-Methylacyl Coenzyme A racemase or AMACR). p504s is found to be overexpressed in human prostatic carcinoma, and exhibits a granular, cytoplasmic staining pattern in malignant glands and cells.15

Publications demonstrate the utility of p504s as an aid to the pathologist in recognizing small foci prostatic carcinoma when used to complement an absence of basal cell staining.16 This can be achieved in a dual stain with the Basal Cell Cocktail (34βE12 + p63) to optimize the use of limited available tissue on small focal cancer biopsies.17

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ihc detection: NKX3.1 (EP356) Rabbit Monoclonal Primary Antibody
NKX3.1 (EP356) Rabbit Monoclonal Primary Antibody

NKX3.1 (EP356) Rabbit Monoclonal Primary Antibody is a sensitive and specific antibody for the detection of NKX3.1 protein. Publications demonstrate that the reliable detection of NKX3.1 may have utility in a number of clinical applications in prostatic carcinoma and breast carcinomas.9

  • Prostatic carcinoma: There is a high frequency of NKX3.1 expression in prostatic adenocarcinoma with greater than 98% sensitivity and specificity.10,11
  • Gurel et al., demonstrated that nearly all cases of metastatic prostate adenocarcinoma were stained by NKX3.1.11
  • Gurel and Chuang showed that nearly all cases of urothelial carcinoma were negative for NKX3.1.11,12
  • NKX3.1-positive prostate carcinoma cells exhibit nuclear staining.11

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Clinical reagents and assays include the p63 (4A4) Mouse Monoclonal Primary Antibody
p63 (4A4) Mouse Monoclonal Primary Antibody

The VENTANA p63 antibody is directed against the p63 molecule, which is highly expressed in the nuclei of human prostatic basal cells and urothelial tissues. This powerful tool can aid the pathologist in the differential diagnosis of prostate cancer in conjunction with morphological findings. Delivering consistently strong nuclear staining, the VENTANA p63 antibody may be used to aid in the differentiation of benign and malignant prostatic lesions.18-20

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ERG (ERP3864) Rabbit Monoclonal Primary Antibody

The ERG (EPR3864) Rabbit Monoclonal Primary Antibody is capable of detecting: Truncated ERG resulting from TMPRSS2:ERG (or other ERG gene fusions) wildtype ERG (most notably expressed in vessel endothelium)

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Reference List

2. American Cancer Society. What are the key statistics about prostate cancer? American Cancer Society Website. Revised 14 Dec 2012. Accessed 9 Nov 2012.
3. Hayes et al. Active Surveillance Compared With Initial Treatment for Men With Low-Risk Prostate Cancer A Decision Analysis. JAMA. 2010; 304(21): 2373-2380. doi:10.1001/jama.2010.1720.
4. Brawer MK, Peehl DM, Stamey TA, Bostwick DG. Keratin immunoreactivity in the benign and neoplastic human prostate. Cancer Res1985; 45(8):3663-7.
5. Hedrick L, Epstein JI. Use of keratin 903 as an adjunct in the diagnosis of prostate carcinoma. Am J Surg Pathol 1989; 13(5):389-96.
6. Shah R B, et al. The diagnostic use of ERG in resolving an “atypical glands suspicious for cancer” diagnosis in prostate biopsies beyond that provided by basal cell and α-methylacyl-CoAracemase markers. Human pathology. 2013; 44(5): 786 -794.
7. Weischenfeldt et al. Integrative Genomic Analyses Reveal an Androgen-Driven Somatic Alteration Landscape in Early-Onset Prostate Cancer. Cancer Cell. 2013; 23:159-170.
8. Park, K et al. Antibody-based detection of ERG rearrangement-positive prostate cancer. Neoplasia. 2010; 12(7): 590.
9. Asch-Kendrick R, et al. NKX3.1 is expressed in ER-positive and AR-positive primary breast carcinomas. J Clin Pathol. 2014; 67:768-71.
10. NKX3.1 (EP356) Package Insert
11. Gurel B, et al. NKX3.1 as a marker of prostatic origin in metastatic tumors. Am J Surg Pathol. 2010; 34:1097-1105.
12. Chuang A, et al. Immunohistochemical differentiation of high-grade prostate carcinoma from urothelial carcinoma. Am J Surg Pathol. 2007; 31:1246-55.
13. Went PT, Sauter G, Oberholzer M, Bubendorf L. Abundant expression of AMACR in many distinct tumor types. Pathol 2006; 38(5):426-32.
14. Dorer R, Odze RD. AMACR immunostaining is useful in detecting dysplastic epithelium in Barrett’s esophagus, ulcerative colitis, and Crohn’s disease. Am J Surg Pathol 2006; 30(7):871-7.
15. Jiang J et al. Using an AMACR (P504S/34βE12/p63 Cocktail for the Detection of Small Focal Prostate Carcinoma in Needle Biopsy Specimens. Am J Clin Pathol. 2005; 123:231-236.
16. Epstein, J I. Diagnosis of limited adenocarcinoma of the prostate. Histopathology. 2012; 60:28-40.
17. Ng, V W et al. Is Triple Immunostaining With 34βE12, p63, and Racemase in Prostate Cancer Advantageous? A Tissue Microarray Study. Am J Clin Pathol. 2007; 127:248-253.
18. Weinstein MH, et al. Diagnostic utility of immunohistochemical staining for p63, a sensitive marker of prostatic basal cells. Mod Pathol 2002; 15:1302-1308.
19. Harton AM, et al. p63 immunocytochemistry improves accuracy of diagnosis with fine-needle aspiration of the breast. AM J Clin Pathol 2007;128:80-85.
20. Parsons et al. p63 protein expression is rare in prostate adenocarcinoma: implications for cancer diagnosis and carcinogenesis. Urology. 2001; 58:619-24.



Prostate cancer disease state

Learn about the prostate cancer disease state, including global incidence, tissue diagnostics and testing guidelines.

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