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The IHC Prostate Multiplex assay is intended for the qualitative identification of Keratin 5/14, p63 protein and P504S by two-color immunohistochemistry (IHC). Keratin 5 and Keratin 14 are expressed in the basal cells of normal prostate glands and prostatic intraepithelial neoplasia (PIN), a precursor lesion to prostatic adenocarcinoma; however, expression of Keratin 5 or Keratin 14 is not seen in invasive prostatic adenocarcinoma. p63 is detected in nuclei of the basal epithelium in normal prostate glands and prostatic intraepithelial neoplasia (PIN), and is not seen in the vast majority of adenocarcinomas of the prostate. Alpha-Methyl Acyl-CoA-Racemase (AMACR or Racemase) is the gene product of P504S, a peroxisomal and mitochondrial enzyme that plays a role in bile acid synthesis and oxidation of branched chain fatty acids. By immunohistochemistry, AMACR/P504S is very frequently expressed in prostatic adenocarcinoma. Prostate glands involved in prostatic intraepithelial neoplasia (PIN) have also been found to express AMACR/P504S, whereas in most cases, AMACR/P504S is negative in benign glands. Together, the presence of Racemase expression in atypical glands, and the absence of basal cells (negative staining for p63, Keratins 5 and 14) can aid in the diagnosis of prostatic adenocarcinoma.
Organ: Genitourinary Tumors
Disease State: Mesothelioma vs. Adenocarcinoma
CPT Code(s): 88344. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
• Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR - • 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm