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Cyclin D1/PRAD1, technical only

Test ID: I CYCLIN TC CPT Code: 88342-TC

Expected Turnaround Time
2 days
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.

Clinical Information
Cyclin D1 is a cell cycle regulator that controls transition from G1 to S phase in normal tissues. A mutation in this protein leads to increased cell proliferation via disruption of downstream pathways, resulting in tumorigenesis. Detection by immunohistochemistry is valuable in the diagnosis and prognosis in a number of tumors including mantle cell lymphoma. Technical component only. Pathologist read not included.


Specimen Requirements


Specimen Requirements
  • Fresh Tissues: Fixative should be at a 20:1 fixative to tissue ratio, 10% neutral buffered formalin (NBF) for 6-72 hours (48-72 hours PREFERRED)
  • Formalin-fixed Paraffin Embedded Tissue (FFPE blocks): FFPE Block, Formalin Fixed
  • Unstained slides: 2 slides (3-5 μM) per stain (min 1 slide per stain), Formalin Fixed

Specimen Stability
  • Fresh Tissue Tissues: ≤ 72 Hours
  • Formalin-fixed Paraffin Embedded Tissue (FFPE blocks): Indefinite
  • Unstained slides: Indefinite

Storage Requirements

15°C to 25°C


Shipping Conditions
Ambient

Shipping Recommendations
  • Fresh Tissues: AMBIENT
  • Formalin-fixed Paraffin Embedded Tissue (FFPE blocks) and unstained slides: AMBIENT, Use a refrigerated (NOT FROZEN) gel pack in the shipment to protect from extreme temperatures. Separate gel pack from specimen.
  • Specimens may be transferred to 70% alcohol for transportation purposes after fixation in 10% NBF or B plus.

Specimen Rejection Criteria

Specimens must be fixed in 10% NBF or B plus. All other fixatives will be rejected. 


Test Details


Synonyms

BCL1, BCL-1, B-Cell Lymphoma 1 Protein, G1/S-specific cyclin-D1, CCND1


Test Method
Immunohistochemistry

Methodology Category
IHC

Regulatory Status
IVD, CE-marked

Special Considerations
  • Fresh Tissues: Specimens may be fixed in formalin for 24-72 hours by collection sites, then transferred to 70% ethanol and stored at 2-8°C for longer term storage if needed. Samples must be tested 3 months after placing in ethanol.
  • Unstained slides: Positively charged glass slides required to prevent background staining and prevent tissue loss. Slides should be left unbaked.