CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
November 2015—Biocare Medical announced the availability of CK HMW + p63 + AMACR (RM) as an in vitro diagnostic double stain for multiplex immunohistochemistry. This patented antibody cocktail may be useful in the evaluation of normal prostate glands, prostatic intraepithelial neoplasia, and prostatic adenocarcinoma.
Previously, this product was available for research use only with CK 5/14, p63, and P504S. This updated version has replaced the P504S rabbit polyclonal antibody with alpha-methylacyl CoA racemase, the equivalent rabbit monoclonal antibody, which will reduce lot-to-lot variability and nonspecific background. CK 5/14 has been replaced with high molecular weight cytokeratin clone 34E12, 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 prostatic intraepithelial neoplasia, prostate adenocarcinoma, and normal prostate glands.
The introduction of this as an IVD product allows clinical laboratories to use this double stain without the additional validation and disclaimer needed to previously run this double stain as a laboratory-developed test.
Biocare Medical, 800-799-9499