POLE mutation-FFPE (Idylla)

Specimen / Container (สิ่งส่งตรวจ/ภาชนะ):

Tissue/ Formalin-fixed paraffin-embedded (FFPE) block

Document required:
For BH: Consent for Genomic Medicine Testing
For B2B: Consent for Genomic Medicine Testing, Please click LINK

Turnaround Time (ระยะเวลารอผล):

From tissue preparation to report within 5 days

Useful For (ประโยชน์การทดสอบ):

POLE Mutation Assay is a fully automated PCR-based assay performed on Biocartis Idylla TM System for the qualitative detection of POLE pathogenic mutations; it includes 17 mutations in exon 9, 11, 13, 14 of POLE. The identification of POLE variants is crucial for stratifying endometrial carcinoma into molecularly distinct subgroups, each associated with divergent clinical outcomes. This assay thereby contributes to the personalized approach in the management of endometrial cancer.

Methodology (วิธีการทดสอบ):

Real-time PCR - Idylla™ System

AliasesName (ชื่อเรียกอื่นๆ) :

POLE ultramutated

Test Code (รหัสการทดสอบ):

092-10-0110

Order Name (ชื่อการทดสอบ):

POLE mutation-FFPE (Idylla)

Collection Specimen Or Container (สิ่งส่งตรวจ/ภาชนะ):

Tissue/ Formalin-fixed paraffin-embedded (FFPE) block

Document required:
For BH: Consent for Genomic Medicine Testing
For B2B: Consent for Genomic Medicine Testing, Please click LINK

Specimen Testing Type (สิ่งส่งตรวจที่ใช้ในการทดสอบ):

Tissue, Formalin-fixed paraffin-embedded (FFPE) block
50-600 mm² (5µm) or 25-300 mm² (10µm), 2 slides/ribbons
required ≥ 10% Neoplastic cell content

Sub Mission Container (ภาชนะส่งตรวจ):

Tissue/Formalin-fixed paraffin-embedded (FFPE) block

Rejection Criteria (เกณฑ์ปฏิเสธสิ่งส่งตรวจ):

Neoplastic cell content <10%

Specimen Stabillity (ความคงตัวของสิ่งส่งตรวจ):

FFPE Tissue section, Ambient for 1 month

Test Code (รหัสการทดสอบ):

092-10-0110

Order Name (ชื่อการทดสอบ):

POLE mutation-FFPE (Idylla)

Method detail (วิธีการทดสอบ):

Real-time PCR - Idylla™ System

Turnaround Time (ระยะเวลารอผล):

From tissue preparation to report within 5 days

Performing Location (หน่วยงานที่ทำการทดสอบ):

Laboratory – Clinical Genomics Tel 14252, 14596

Specimen Retention Time (ระยะเวลาเก็บสิ่งส่งตรวจ):

1 month

Test Code (รหัสการทดสอบ):

092-10-0110

Order Name (ชื่อการทดสอบ):

POLE mutation-FFPE (Idylla)

Clinical Information (ข้อมูลทางคลินิก):

The POLE mutation test is a targeted molecular assay designed to detect pathogenic mutations within the exonuclease domains of POLE from formalin-fixed paraffin-embedded tissue. POLE encode essential catalytic and proofreading subunits of DNA polymerases ε, which maintain genomic integrity during DNA replication. This diagnostic test is critical for molecular stratification of endometrial carcinomas, offering valuable prognostic insights and informing personalized treatment approaches.

Clinical Reference (เอกสารอ้างอิง):

1. Levine, D., The Cancer Genome Atlas Research Network. Integrated genomic characterization of endometrial carcinoma. Nature 497, 67–73 (2013). https://doi.org/10.1038/nature12113
2. Ma, X., Dong, L., Liu, X. et al. POLE/POLD1 mutation and tumor immunotherapy. J Exp Clin Cancer Res 41, 216 (2022). https://doi.org/10.1186/s13046-022-02422-1