Test Catalog

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)

Collection:

Preferred Specimen:

1. Pathologist to review all diagnostic slides and select a single paraffin block from the biopsy. (Submission of all positive blocks is preferred.)
2. Tumor quality: tumor with good morphology (i.e., well fixed) lacking areas of crush, mechanical distortion and over fragmentation.
3. Place corresponding paraffin block into glassine envelope, then into the plastic biohazard specimen bag and seal.

Alternate Specimen:

1. 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).
2. 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.
3. Allow slides to dry at room temperature for a minimum of one hour.
4. 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.
5. Place the plastic slide holder into the plastic biohazard specimen bag and seal.

References:

1. Van Rhijn B; et al: J Clinic Oncol. 2003 May;21(10):1912-1921.
2. Cheng L et al Future Oncol. 2009 Aug;5(6):843-57. Review.
3. 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.