TEST NAME

SPECIMEN/REQUIREMENT

Breast Cancer Prognostic Test

ProSigna Test

Paraffin block (FFPE) OR 10μm FFPE sections X 6

RNA extraction and RNA QC

For sample QC prior to ProSigna Test

Predictive Immunohistochemistry Marker for Immunotherapies

Dako PD-L1 PharmDx 22C3 IHC for Pembrolizumab

Paraffin block (FFPE) /

4μm x 5 unstained slides on coated slides or Platinumpro coated slide and H&E stain x 1

Dako PD-L1 PharmDx IHC 28-8

Ventana PD-L1 SP263 for Nivolumab / Durvalumab

Ventana PD-L1 SP142 for Atezolizumab

Paraffin block (FFPE) /

4μm x 5 unstained slides on Platinumpro coated slide and H&E stain x 1

Molecular Test Package for the 1^st Line Treatment of NSCLS

Comprehensive Package for NSCLC 1:
EGFR mutation + ALK IHC + ROS1 FISH Test + BRAF V600E mutation + MET exon 14-skipping mutation + RET FISH Test + PD-L1 IHC (clone 22C3)

Paraffin block (FFPE) OR
4-5μm x 15 unstained slides on uncoated/ Platinum slide, 4μm x 5 unstained slides on Platinum slides and H&E stain x 1

Pharmacogenetics Tests Package for NSCLC

NSCLC Package for minority actionable mutations
(First-line)  (^#)
BRAF V600E mutation + MET exon 14-skipping mutation + RET FISH Test

Paraffin block (FFPE) OR

4-5μm x 15 unstained slides on uncoated/ Platinum slide, 4μm x 5 unstained slides on Platinum slides and H&E stain x 1

NSCLC EGFR Test Package 1  (^#):
EGFR mutation + ALK IHC + ROS1 FISH + PD-L1 IHC 22C3

NSCLC EGFR Test Package 2  (^#):
EGFR Mutation + ALK IHC Test + ROS1 FISH Test

NSCLC EGFR Test Package 3  (^#):
EGFR Mutation + ALK IHC Test

NSCLC EGFR Test Package 4  (^#):
EGFR Mutation + ROS1 FISH + BRAF V600E mutation

EGFR (exons 18-21) Mutation Test (FDA approved)

Paraffin block (FFPE) OR
5μm x 15 unstained slides and H&E stain x 1

EGFR (exons 18-21) Mutation Test on pleural fluid

Fresh pleural fluid
* Advance booking is required.

EGFR (exons 18-21)
Mutation Test on peripheral blood (FDA approved)

4 x 3mL Peripheral blood with EDTA anti-coagulant
* Advance booking is required.

EGFR T790M Mutation Test on peripheral blood (by Digital PCR)

2x 10mL Peripheral blood in Streck BCT

HER2 exon 20 mutation

Paraffin block (FFPE) OR

5μm x 15 unstained slides and H&E stain x 1

MET Mutation Test (Exon 14 splice site alteration)

BRAF V600E Mutation Test (by Sanger sequencing)

ALK Translocation Test by FISH (FDA approved)

Paraffin block (FFPE) OR

4μm x 5 unstained slides on charged slides and H&E stain x 1

ALK Immunohistochemistry (with report)

RET Translocation Test by FISH

ROS1 Translocation Test by FISH

MET Amplification Test by FISH

Pharmacogenetics Tests Package for mCRC

KRAS Mutation + NRAS Mutation Test

Paraffin block (FFPE) OR 5μm x 15 unstained slides and H&E stain x 1

KRAS (codons 12, 13, 61, 117, 146) Mutation Test

NRAS (codons 12, 13, 61, 117, 146) Mutation Test

BRAF V600E Mutation Test (by Sanger sequencing)

Microsatellite instability molecular Test (Bethesda Panel) + IHC for 4 mismatch repair proteins

1. Paraffin block (FFPE) OR 5μm x 15 unstained slides and H&E stain x 1

2. FFPE block of non-tumoral tissue is required.

Microsatellite instability molecular Test (Bethesda Panel)

IHC of 4 mismatch repair proteins (MMR)

Paraffin block (FFPE) OR 4μm x 8 unstained slides on charged slides and H&E stain x 1

Pharmacogenetics Tests Package for Ovarian Cancer

BRCA1 and BRCA2 mutation test on primary tumor

Paraffin block (FFPE) OR 5μm x 15 unstained slides and H&E stain x 1

Germline BRCA1 and BRCA2 test (Mutation + Deletion)

2 x 3mL Peripheral blood with EDTA anti-coagulant

Molecular Tests for Endometrial Cancer

Package for Endometrial Cancer:
POLE exonuclease (6 exons) + MMR IHC + p53 IHC

Paraffin block (FFPE) OR

5μm x 15 unstained slides and H&E stain x 1

POLE Exonuclease Domain Mutation Test

Molecular Tests for Urothelial Cancer

FGFR gene mutations/Translocations by Qiagen FGFR RGQ Test

Paraffin block (FFPE) OR
5μm x 15 unstained slides and H&E stain x 1

Molecular Tests for Thyroid Cancer

Germline RET Mutation Test

2 vials of 3mL peripheral blood in EDTA blood collection tube. Special consent required.

Somatic RET Mutation Test

Paraffin block (FFPE) OR
5μm x 15 unstained slides and H&E stain x 1

RET Translocation Test by FISH

Paraffin block (FFPE) OR
4μm x 5 unstained slides and H&E stain x 1

Molecular Tests for Lymphoma / Lymphoproliferative Disorders

Package for Lymphoma 1:
MYC + BCL2 and BCL6 Translocation Test by FISH

Paraffin block (FFPE) OR
4μm x 8 unstained slides on charged slides and H&E stain x 1

Package for Lymphoma 2 (Reflex):
MYC Translocation Test by FISH
   +/- BCL2 and BCL6 Translocation Test

        by FISH Reflex BCL2 and BCL6

        break-apart will be performed when
        MYC break-apart FISH was positive

Paraffin block (FFPE) OR
4μm x 8 unstained slides on charged slides and H&E stain x 1

TCR-beta / gamma Clonality Test

Paraffin block (FFPE) OR

5μm x 15 unstained slides and

H&E stain x 1 / 3ml EDTA PB / BM

IgH Clonality Test

IgK + IgL Clonality Test

MYC Translocation Test by FISH

Paraffin block (FFPE) OR

4μm x 5 unstained slides on charged slides and H&E stain x 1

BCL2 Translocation Test by FISH

BCL6 Translocation Test by FISH

CCND1 Translocation Test by FISH

DUSP22-IRF4 Translocation Test by FISH

MALT1 Translocation Test by FISH

MYD88 L265P Mutation Test (by Sanger sequencing)

Paraffin block (FFPE) OR

5μm x 15 unstained slides and

H&E stain x 1 / 3ml EDTA PB / BM

Next Generation Sequencing panels for solid cancers

CUHK Somatic Mutation v3 Test for Solid Cancers with immuno-oncology package:
Consists of CUHK Somatic Mutation v3 Test, PD-L1 IHC test and MSI/dMMR test

Paraffin block (FFPE) OR
5µm x 25 unstained slides on charged slides. (*1)

CUHK Somatic Mutation v3 Test for Solid Cancers

Paraffin block (FFPE) OR
5µm x 20 unstained slides on charged slides. (*1)

Focus mutation panel for solid cancers (Tissue)

Roche Avenio surveilliance mutation panel for solid cancers on peripheral blood

2x 10mL peripheral blood in Streck BCT.

Illumina pan cancer RNA-seq (1385 genes)

Paraffin block (FFPE) OR
5µm x 20 unstained slides on charged slides. (*1)

RNA fusion panel (15 genes)
(15 genes including ALK, ROS1, RET, MET, BRAF, EGFR, FGFR1, FGFR2, FGFR3, NTRK1, NTRK2, NTRK3, PDGFRA, NRG, RAF1)

Gene Mutation / PCR Tests for Solid Cancers (by Gene Name)

ALK Mutation Test (Exon 22-25)

Paraffin block (FFPE) OR
5μm x 15 unstained slides and H&E stain x 1

BCOR exon 15 internal tandem duplication

BRAF V600E Mutation Test (by Sanger sequencing)

Somatic BRCA1 and BRCA2 mutation test

CTNNB1 exon 3 mutation test

DICER1 (exon 26 and exon 27) mutation test

EGFR (exons 18-21) Mutation Test (FDA approved)

EGFR (exons 18-21) Mutation Test on pleural fluid

Fresh pleural fluid
* Advance booking is required.

EGFR (exons 18-21)
Mutation Test on peripheral blood (FDA approved)

4 x 3mL Peripheral blood with EDTA anti-coagulant
* Advance booking is required.

EGFR T790M Mutation Test on peripheral blood
(by Digital PCR)

2 x 10mL peripheral blood in Streck BCT

FGFR gene mutations/Translocations by Qiagen FGFR RGQ Test

Paraffin block (FFPE) OR
5μm x 15 unstained slides and H&E stain x 1

FH mutation test

FOXL2 (codon 134) mutation test

Germline BRCA1 and BRCA2 test (Mutation + Deletion)

2 x 3mL Peripheral blood with EDTA anti-coagulant

Germline RET Mutation Test

2 vials of 3mL peripheral blood in EDTA blood collection tube. Special consent required.

H3F3A (exon 2) mutation test

Paraffin block (FFPE) OR
5μm x 15 unstained slides and
H&E stain x 1

H3F3B (exon 2) mutation test

HER2 exon 20 mutation

HRAS gene hotspot mutation detection (exon 2, 3 and 4)

IDH1 Mutation Test

IDH1 and IDH2 hotspot mutation detection

KIT Mutation Test (Exon 9, 11, 13, 17 and 18)

KIT & PDGFRA Mutation Test

KRAS (codons 12, 13, 61, 117, 146) Mutation Test

MET Mutation Test (Exon 14 splice site alteration)

MGMT Promoter Hypermethylation Test

Microsatellite instability molecular Test (Bethesda Panel)

1. Paraffin block (FFPE) OR 5μm x 15 unstained slides and H&E stain x 1
2. FFPE block of non-tumoral tissue is required.

MYOD1 exon 1 mutation test

Paraffin block (FFPE) OR
5μm x 15 unstained slides and
H&E stain x 1

NRAS (codons 12, 13, 61, 117, 146) Mutation Test

PIK3CA gene hotspot mutation detection
(Exon 7, 9 and 20)

POLE Exonuclease Domain Mutation Test

Somatic RET Mutation Test

FISH Tests for Sarcomas or Solid Cancers (by Gene Name)

ALK Translocation Test by FISH (FDA approved)

Paraffin block (FFPE) OR

4μm x 5 unstained slides on charged slides and H&E stain x 1

BRAF Translocation Test by FISH

HER2 FISH (FDA approved)

RET Translocation Test by FISH

ROS1 Translocation Test by FISH

MET Amplification Test by FISH

1p/19q Test by FISH

MYCN Amplification Test by FISH

NTRK1 Translocation Test by FISH

NTRK2 Translocation Test by FISH

NTRK3 Translocation Test by FISH

BCOR Translocation Test by FISH

CIC4 Translocation Test by FISH

CSF1 Translocation Test by FISH

EWSR1 Translocation Test by FISH

ETV6 Translocation Test by FISH

CDK4 Amplification Test by FISH

COL1A1-PDGFB Dual-Color Dual-Fusion Test by FISH

DDIT3 Translocation Test by FISH

DUSP22-IRF4 Translocation Test by FISH

DUX-CIC4 Fusion Test by FISH

FGFR2 Translocation Test by FISH

FGFR3 Translocation Test by FISH

FOXO1 Translocation Test by FISH

FUS Translocation Test by FISH

HMGA2 Translocation Test by FISH

MAML2 Translocation Test by FISH

MDM2 Amplification Test by FISH

MEGA5 Translocation Test by FISH

MYB Translocation Test by FISH

MYBL1 Translocation Test by FISH

NR4A3 Translocation Test by FISH

PLGA1 Translocation Test by FISH

SS18 Translocation Test by FISH

TFE3 Translocation Test by FISH

TGFBR3 Translocation Test by FISH

USP6 Translocation Test by FISH

YWHAE Translocation Test by FISH

Molecular Tests for Solid Cancer Fusion Transcripts (by RT-PCR)

EWSR1-FLI1,EWSR1-ERG
     for Ewing Sarcoma

Paraffin block (FFPE) OR

5μm x 15 unstained slides and

H&E stain x 1

ASPSL-TFE3
     for Alveolar Soft Part Sarcoma

BRD4-NUT BRD3-NUT
     for NUT Midline Carcinoma

COL1A1-PDGFB
     for Dermatofibrosarcoma
      Protuberans,Giant Cell Fibroblastoma

ETV6-NTRK3
     for Congenital/Infantile Fibrosarcoma,  
     Congenital MesoblasticNephroma

EWSR1-ATF1,EWSR1-CREB1
     for Clear Cell Sarcoma

FUS-CREB3L2, FUS-CREB3L1
     for Low-Grade Fibromyxoid Sarcoma

MECT1-MAML2
     for Mucoepidermoid Carcinoma

MYB-NFIB
     for Adenoid Cystic Carcinoma

NR3A3-EWS
    for Extraskeletal Myxoid
     Chondrosarcoma

PAX3-FOXO1A, PAX7-FOXO1A
     for Alveolar Rhabdomyosarcoma

SYT-SSX1,SYT-SSX2
     for Synovial Sarcoma

TPM3-ALK, TPM4-ALK, CLTC-ALK, RANBP2-ALK
     for Inflammatory myofibroblastic tumor

Molecular Tests for Sarcoma (by FISH)

EWSR1 Translocation test (FISH)

Tissue Block

DDIT3 Translocation test (FISH)

Tissue Block

FOXO1 Translocation test (FISH)

Tissue Block

FUS Translocation test (FISH)

Tissue Block

SS18 Translocation test (FISH)

Tissue Block

CDK4 Amplification Test (FISH) for liposarcoma

Tissue Block

MDM2 Amplification (FISH)

Tissue Block

TFE3 Translocation Test (FISH)

Tissue Block

Other Molecular Tests

cobas HPV test for Thinprep specimen
(FDA-approved for detection of 14 HR HPV + HPV16/18 genotyping)

4 mL PreservCyt (ThinPrep) specimen

HPV genotyping for FFPE specimens

Paraffin block (FFPE) OR
5μm x 15 unstained slides and H&E stain x 1

PCR for Mycobacterium leprae (Leprosy)

Paraffin block (FFPE) OR
5μm x 15 unstained slides

Mycobacterium Tuberculosis real-time PCR test

Remarks:

1. For (^#) items in the NSCLC Package can be ordered sequentially.

2. For (*1) items, frozen tissues are also accepted. Please contact UPS (Tel: 3505 3949) for further arrangement.

3. Please call 3505-3949 for advance booking.