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Overview
ข้อมูลทั่วไป Specimen
ข้อมูลสิ่งส่งตรวจ Performance
ข้อมูลการทดสอบ Clinical & Interpretation
ข้อมูลทางคลินิก
 
Test Code (รหัสการทดสอบ):
LAB68
Order Name (ชื่อการทดสอบ):
Oncomine 50 genes COMBO Tissue (FFPE) + Blood
 
Specimen / Container (สิ่งส่งตรวจ/ภาชนะ):
Cell Free : Blood/ Streck 10 mL, 2 tubes
FFPE : Tissue/Formalin-fixed paraffin-embedded (FFPE) block
 
Turnaround Time (ระยะเวลารอผล):
Oncomine Precision Panel (50 genes) - Cell-Free reported within 5 days
Oncomine Precision Panel (50 genes) - FFPE  reported within 14 days 
 
Useful For (ประโยชน์การทดสอบ):
This test is beneficial for patients who have both blood samples and FFPE tissue samples, and aimed to testing for targeted therapy in both types of samples. 
The assay detects SNVs, InDels, CNVs, and gene fusions across 50 key genes in both blood and FFPE samples, providing comprehensive biomarker detection for optimizing cancer treatment.

Gene list:
DNA Hotspots: AKT1, AKT2, AKT3, ALK, AR, ARAF, BRAF, CDK4, CDKN2A, CHEK2, CTNNB1, EGFR, ERBB2, ERBB3, ERBB4, ESR1, FGFR1, FGFR2, FGFR3, FGFR4, FLT3, GNA11, GNAQ, GNAS, HRAS, IDH1, IDH2, KIT, KRAS, MAP2K1, MAP2K2, MET, MTOR, NRAS, NTRK1, NTRK2, NTRK3, PDGFRA, PIK3CA, PTEN, RAF1, RET, ROS1, SMO, TP53.

Copy Number Variation (CNVs): ALK, AR, CD274, CDKN2A, EGFR, ERBB2, FGFR1, FGFR2, FGFR3, KRAS, MET, PIK3CA, PTEN.

Inter-genetic fusions: ALK, BRAF, ESR1, FGFR1, FGFR2, FGFR3, MET, NRG1, NTRK1, NTRK2, NTRK3, NUTM1, RET, ROS1, RSPO2, RSPO3.

Intra-genetic fusions: AR, EGFR, MET.
 
Methodology (วิธีการทดสอบ):
Next generation sequencing (NGS), Target sequencing
 
AliasesName (ชื่อเรียกอื่นๆ) :
Cell-free DNA,
cfDNA,
ctDNA,
Liquid biopsy,  
FFPE tissue mutation
 
 
 
Test Code (รหัสการทดสอบ):
LAB68
Order Name (ชื่อการทดสอบ):
Oncomine 50 genes COMBO Tissue (FFPE) + Blood
 
Collection Specimen Or Container (สิ่งส่งตรวจ/ภาชนะ):
Cell Free : Blood/ Streck 10 mL, 2 tubes
FFPE : Tissue/Formalin-fixed paraffin-embedded (FFPE) block
 
Specimen Testing Type (สิ่งส่งตรวจที่ใช้ในการทดสอบ):
Cell Free : Whole blood 10 mL Streck tube, 2 tubes
FFPE : Tissue, Formalin-fixed paraffin-embedded (FFPE) block, 5 x 10 µm FFPE tissue section, 25 – 300 mm², 7 slides/ribbons
(required ≥ 10% Neoplastic cell content, preferable ≥30% Neoplastic cell content)
 
Sub Mission Container (ภาชนะส่งตรวจ):
Cell Free : Streck tube
FFPE : Tissue/Formalin-fixed paraffin-embedded (FFPE) block
 
Rejection Criteria (เกณฑ์ปฏิเสธสิ่งส่งตรวจ):
Neoplastic cell content <10%
 
Specimen Stabillity (ความคงตัวของสิ่งส่งตรวจ):
FFPE : Ambient for 1 month
Blood : Ambient temperature < 7 days
 
 
 
Test Code (รหัสการทดสอบ):
LAB68
Order Name (ชื่อการทดสอบ):
Oncomine 50 genes COMBO Tissue (FFPE) + Blood
 
Turnaround Time (ระยะเวลารอผล):
Oncomine Precision Panel (50 genes) - Cell-Free reported within 5 days
Oncomine Precision Panel (50 genes) - FFPE  reported within 14 days 
 
Performing Location (หน่วยงานที่ทำการทดสอบ):
Clinical Genomics Tel. 14252
 
Specimen Retention Time (ระยะเวลาเก็บสิ่งส่งตรวจ):
Cell Free : 1 Day
FFPE : 1 month
 
 
 
Test Code (รหัสการทดสอบ):
LAB68
Order Name (ชื่อการทดสอบ):
Oncomine 50 genes COMBO Tissue (FFPE) + Blood
 
 
Clinical Information (ข้อมูลทางคลินิก):
The Oncomine Precision Assay enables simultaneous detection of hotspot mutations (substitutions, insertions, and deletions), copy number variations (CNVs), and gene fusions across 50 cancer driver genes such as EGFR, BRAF, KRAS, ALK, ROS1, NTRK and RET. The biomarkeres in the panel have been identified as frequently mutated in multiple cancer types including non-small cell lung, breast, Melanoma, kidney, bladder, Head and neck, pancreatic, thyroid, small cell lung and others.
 
Clinical Reference (เอกสารอ้างอิง):
1. https://www.thermofisher.com/order/catalog/product/A46291 (Retrieved 16 Sep 2024)