CertNDx Bladder Cancer Assay:
Use: Aid in the staging and grading of bladder cancers
Methodology: FGFR3 status is determined by Real-Time PCR analysis for mutations located in Exons 7, 10 and 15 of the FGFR3 gene. Ki-67 status is assessed by immunohistochemistry with computer assisted image analysis.
CPT Codes: 83890, 83896, 83900, 83901, 83907, 83912, 88342, 88363
Tumor Volume: Block containing at least 1 mm2 tumor cells (Minimum 20% tumor:normal tissue ratio)
- Pathologist to review all diagnostic slides and select a single paraffin block from the biopsy. (Submission of all positive blocks is preferred.)
- Tumor quality: tumor with good morphology (i.e., well fixed) lacking areas of crush, mechanical distortion and over fragmentation.
- Place corresponding paraffin block into glassine envelope, then into the plastic biohazard specimen bag and seal.
- If block cannot be sent, select block as above, perform minimal facing, and cut five (5) consecutive 5 μm serial sections (avoid “chatter” and uneven thickness).
- Center one section on each glass slide (cannot be less than 5 mm from any edge), numbered 1-5 (with a graphite pencil) corresponding to serial sections respectively, avoiding wrinkles, folds or tears.
- Allow slides to dry at room temperature for a minimum of one hour.
- Place the five (5) slides into the plastic slide holder provided in the Block/Slide Mailer, insert small foam piece or tissue (to immobilize slides) before firmly pressing the top to close.
- Place the plastic slide holder into the plastic biohazard specimen bag and seal.
- Van Rhijn B; et al: J Clinic Oncol. 2003 May;21(10):1912-1921.
- Cheng L et al Future Oncol. 2009 Aug;5(6):843-57. Review.
- Burger M et al Eur Urol. 2008 Oct;54(4):835-43. Epub 2007 Dec 26.
This product is a laboratory-developed test (LDT) provided as a service to physicians. This product is not an in-vitro diagnostic (IV) kit and is not sold directly to patients or to other laboratories.