IVD CK HMW + p63 + AMACR (RM) Available from Biocare Medical

Concord, CA, August 27, 2015 – Biocare Medical is proud to announce the availability of CK HMW + p63 + AMACR (RM) as an IVD double-stain for Multiplex IHC™. This patented antibody cocktail may be useful in the evaluation of normal prostate glands, prostatic intraepithelial neoplasia (PIN) and prostatic adenocarcinoma (1,2).

Previously, this product was available as an RUO with CK 5/14, p63 and P504S. This updated version has replaced the P504S rabbit polyclonal antibody with AMACR, the equivalent rabbit monoclonal antibody, which will reduce lot-to-lot variability and non-specific background. CK 5/14 has been replaced with high molecular weight cytokeratin clone 34βE12, which is directed to CK1, 5, 10, 14, and specifically stains basal cells in prostate specimens. This updated mixture of antibodies was selected to provide specific and sensitive staining of PIN, prostate adenocarcinoma and normal prostate glands.

The introduction of this as an IVD (in vitro diagnostic) product will now allow clinical laboratories to utilize this double stain without the additional validation and disclaimer needed to previously run this double stain as a LDT (lab developed test). An IVD label also provides reasonable assurance of the product’s safety and effectiveness.

Biocare Medical is an innovator in developing world-class IHC antibodies and reagents for clinical cancer diagnostics. With the patented IVD CK HMW + p63 + AMACR (RM) Multiplex IHC™ now available, Biocare has improved upon the original groundbreaking prostate double-stain, also a Biocare exclusive development.

About CK HMW + p63 + AMACR (RM)
Studies have shown that combinations of CK HMW [34βE12], p63, and/or AMACR may be useful in the evaluation of normal prostate glands, prostatic intraepithelial neoplasia (PIN) and prostatic adenocarcinoma (3). In prostate, CK HMW [34βE12] has been shown to be a useful marker of basal cells of normal glands and PIN, a precursor lesion to prostatic adenocarcinoma; whereas invasive prostatic adenocarcinoma typically lacks a basal cell layer (3-5). p63, a homolog of the tumor suppressor p53, has been detected in nuclei of the basal epithelium in normal prostate glands; however, it was not expressed in malignant tumors of the prostate (6). α-Methylacyl coenzyme A racemase (AMACR), also known as P504S, has been shown to be a specific marker of prostatic adenocarcinoma (7-10). Additionally, prostate glands involved in PIN have been found to express AMACR, whereas AMACR was nearly undetectable in benign glands (10-11).
U.S. Patent 8,603,765 and patents pending

Prostate cancer stained with CK HMW + p63 + AMACR (RM)
Prostate cancer stained with CK HMW + p63 + AMACR (RM)

About Biocare Medical
Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry (IHC) instrumentation and the full range of reagents for IHC and ISH lab testing. Biocare Medical is the market leader in simultaneous Multiplex IHC detection and antibody development, which aids in the assessment of clinical cases and accelerates turnaround time. The company’s customers include clinical histology laboratories, pharmaceutical companies, CROs, and biotechnology companies as well as academic, government, military, and other non-profit laboratories. Biocare Medical offers an expanding portfolio of integrated products to address the rapidly growing cancer and infectious disease diagnostic and research markets using tissue immunostaining and in situ hybridization methods. Biocare Medical is headquartered and has manufacturing facilities in Concord, California, and has a global distribution network. For more information, please visit www.biocare.net.

References
1. Shah RB, et al. Am J Clin Pathol. 2004 Oct; 122(4):517-23. 2. Sung MT, et al. Hum Pathol. 2007 Feb; 38(2):332-41. 3. Bostwick DG, Qian J. Mod Pathol. 2004 Mar; 17(3):360-79. 4. Humphrey PA. J Clin Pathol. 2007 Jan; 60(1):35-42. 5. Shah RB, et al. Am J Surg Pathol. 2002 Sep; 26(9):1161-8. 6. Signoretti S, et al. 2000 Dec; 157(6):1769-75. 7. Xu J, et al. Cancer Res. 2000 Mar 15; 60(6):1677-82. 8. Rubin MA, et al. JAMA. 2002 Apr 3; 287(13):1662-70. 9. Luo J, et al. Cancer Res. 2002 Apr 15; 62(8):2220-6. 10. Zhou M, et al. Am J Surg Pathol. 2002 Jul; 26(7):926-31. 11. Wu CL, et al. Hum Pathol. 2004 Aug; 35(8):1008-13.