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SOLID TUMOR MOLECULAR PROFILE - Fulgent Genetics...Fulgent Genetics 4978 Santa Anita Ave., Suite 205...

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Fulgent's Solid Tumor Molecular Profile targets 170 cancer-related genes carefully selected to provide comprehensive and efficient analysis of therapeutically relevant alterations as well as those being studied in current and upcoming clinical trials. Our expert curation team creates each report considering the mutational status of all tested genes, resulting in a personalized profile including recommendations for approved therapies, counter-indicated therapies, off-label options, and active trials. With this powerful tool in hand, patients and care teams are armed with the best information possible to navigate the increasingly complex battle against cancer. HIGHLIGHTS TEST DETAILS TAT: 2 weeks Sample type: FFPE *See sample requirements for details Coverage and Detection: • ≥ 5% variant allele frequency • 99% at ≥ 250x coverage • Competitive detection of a broad range of variant types • Single nucleotide variants • Small indels • Amplifications • Splice variants • Gene fusions (from 50 genes) SOLID TUMOR MOLECULAR PROFILE Comprehensive Analysis, Meaningful Results FFPE Specimens DNA and RNA Extraction Sequence Analysis Report Gene Count: 170 genes Highly selective gene list based on the latest research Simultaneous analyses of DNA and RNA RNA allows for optimal detection of gene fusions Tumor mutation burden analysis INFORMED CONSENT FOR GENETIC ANALYSIS | FLY-SomaticSolid-v3.2 | 2018
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Page 1: SOLID TUMOR MOLECULAR PROFILE - Fulgent Genetics...Fulgent Genetics 4978 Santa Anita Ave., Suite 205 Temple City, California 91780, USA SHIPPING CHECKLIST AND INSTRUCTIONS Test Requisition

Fulgent's Solid Tumor Molecular Profile targets 170 cancer-related genes carefully selected to provide comprehensive and efficient analysis of therapeutically relevant alterations as well as those being studied in current and upcoming clinical trials. Our expert curation team creates each report considering the mutational status of all tested genes, resulting in a personalized profile including recommendations for approved therapies, counter-indicated therapies, off-label options, and active trials. With this powerful tool in hand, patients and care teams are armed with the best information possible to navigate the increasingly complex battle against cancer.

HIGHLIGHTS

TEST DETAILS

TAT: 2 weeks

Sample type: FFPE*See sample requirements for details

Coverage and Detection:• ≥ 5% variant allele frequency• 99% at ≥ 250x coverage

• Competitive detection of a broad range of variant types • Single nucleotide variants • Small indels • Amplifications • Splice variants • Gene fusions (from 50 genes)

SOLID TUMOR MOLECULAR PROFILE

Comprehensive Analysis, Meaningful Results

FFPE Specimens DNA and RNAExtraction

Sequence Analysis Report

Gene Count: 170 genes

Highly selective gene list based on the latest researchSimultaneous analyses of DNA and RNA • RNA allows for optimal detection of gene fusions Tumor mutation burden analysis

INFORMED CONSENT FOR GENETIC ANALYSIS | FLY-SomaticSolid-v3.2 | 2018

Page 2: SOLID TUMOR MOLECULAR PROFILE - Fulgent Genetics...Fulgent Genetics 4978 Santa Anita Ave., Suite 205 Temple City, California 91780, USA SHIPPING CHECKLIST AND INSTRUCTIONS Test Requisition

SPECIMEN REQUIREMENTS

1 FFPE Tumor Block • Include 1 H&E slide if available

Solid Tumor Molecular Profile

Shipping Address

Fulgent Genetics 4978 Santa Anita Ave., Suite 205

Temple City, California 91780, USA

SHIPPING CHECKLIST AND INSTRUCTIONS

Test Requisition FormPatient Insurance Information

Pathology ReportsTumor Specimens

Insert slides or FFPE block into the

sample-specific container (i.e. slide box) provided in the Fulgent

specimen kit.

1

General Specifications: • Adequate specimen volume must be submitted to ensure the highest quality of analysis. • Minimum: 20% tumor cell content

10 Unstained Slides • Positively charged, unbaked • 4 - 5 microns sections • Tissue surface area: ≥ 5mm x 5mm • Include 1 H&E slide if available

Label samples with patient-specific

identifiers and place into the specimen kit.

2Insert specimen kit and the required paperwork

into the provided shipping bag.

3Seal the shipping bag

and apply the the appropriate shipping labels. Ship promptly.

4

HQ | 4978 Santa Anita Ave., Suite 205, Temple City, California, 91780 P | (+1) 626-350-0537 F | (+1) 626-454-1667W | FulgentGenetics.com E | [email protected]

CLIA | 05D2043189 CA | CLF 00342581 CAP | 8042697 D# | FLY-SomaticSolid-v3.22018 © Fulgent Genetics. All rights reserved.

OR

Page 3: SOLID TUMOR MOLECULAR PROFILE - Fulgent Genetics...Fulgent Genetics 4978 Santa Anita Ave., Suite 205 Temple City, California 91780, USA SHIPPING CHECKLIST AND INSTRUCTIONS Test Requisition

SOLID TUMOR MOLECULAR PROFILE

Comprehensive Analysis, Meaningful Results

FULL GENE LIST: 170

ABL1, AKT1, AKT2, AKT3, ALK, APC, AR, ARID1A, ATM, ATR, AXL, BAP1, BARD1, BCL2, BCL6, BRAF, BRCA1, BRCA2, BRIP1, BTK, CARD11, CCND1, CCND2, CCND3, CCNE1, CD79A, CD79B, CDH1, CDK12, CDK4, CDK6, CDKN2A, CEBPA, CHEK1, CHEK2, CREBBP, CSF1R, CTNNB1, DDR2, DNMT3A, EGFR, EML4, EP300, ERBB2, ERBB3, ERBB4, ERCC1, ERCC2, ERG, ESR1, ETS1, ETV1, ETV4, ETV5, EWSR1, EZH2, FAM175A, FANCI, FANCL, FBXW7, FGF1, FGF10, FGF14, FGF19, FGF2, FGF23, FGF3, FGF4, FGF5, FGF6, FGF7, FGF8, FGF9, FGFR1, FGFR2, FGFR3, FGFR4, FLI1, FLT1, FLT3, FOXL2, GEN1, GNA11, GNAQ, GNAS, HNF1A, HRAS, IDH1, IDH2, INPP4B, JAK2, JAK3, KDR, KIF5B, KIT, KMT2A, KRAS, LAMP1, MAP2K1, MAP2K2, MCL1, MDM2, MDM4, MET, MLH1, MLLT3, MPL, MRE11A, MSH2, MSH3, MSH6, MTOR, MUTYH, MYC, MYCL1, MYCN, MYD88, NBN, NF1, NOTCH1, NOTCH2, NOTCH3, NPM1, NRAS, NRG1, NTRK1, NTRK2, NTRK3, PALB2, PAX3, PAX7, PDGFRA, PDGFRB, PIK3CA, PIK3CB, PIK3CD, PIK3CG, PIK3R1, PMS2, PPARG, PPP2R2A, PTCH1, PTEN, PTPN11, RAD51, RAD51B, RAD51C, RAD51D, RAD54L, RAF1, RB1, RET, RICTOR, ROS1, RPS6KB1, SLX4, SMAD4, SMARCB1, SMO, SRC, STK11, TERT, TET2, TFRC, TMPRSS2, TP53, TSC1, TSC2, VHL, XRCC2

HQ | 4978 Santa Anita Ave., Suite 205, Temple City, California, 91780 P | (+1) 626-350-0537 F | (+1) 626-454-1667W | FulgentGenetics.com E | [email protected]

CLIA | 05D2043189 CA | CLF 00342581 CAP | 8042697 D# | FLY-SomaticGL-v2.12018 © Fulgent Genetics. All rights reserved.

SMALL VARIANT DETECTION (SNVS AND INDELS): 148

AKT1, AKT2, AKT3, ALK, APC, AR, ARID1A, ATM, ATR, BAP1, BARD1, BCL2, BCL6, BRAF, BRCA1, BRCA2, BRIP1, BTK, CARD11, CCND1, CCND2, CCNE1, CD79A, CD79B, CDH1, CDK12, CDK4, CDK6, CDKN2A, CEBPA, CHEK1, CHEK2, CREBBP, CSF1R, CTNNB1, DDR2, DNMT3A, EGFR, EP300, ERBB2, ERBB3, ERBB4, ERCC1, ERCC2, ERG, ESR1, EZH2, FAM175A, FANCI, FANCL, FBXW7, FGF1, FGF10, FGF14, FGF2, FGF23, FGF3, FGF4, FGF5, FGF6, FGF7, FGF8, FGF9, FGFR1, FGFR2, FGFR3, FGFR4, FLT1, FLT3, FOXL2, GEN1, GNA11, GNAQ, GNAS, HNF1A, HRAS, IDH1, IDH2, INPP4B, JAK2, JAK3, KDR, KIT, KMT2A, KRAS, MAP2K1, MAP2K2, MCL1, MDM2, MDM4, MET, MLH1, MLLT3, MPL, MRE11A, MSH2, MSH3, MSH6, MTOR, MUTYH, MYC, MYCL1, MYCN, MYD88, NBN, NF1, NOTCH1, NOTCH2, NOTCH3, NPM1, NRAS, NRG1, PALB2, PDGFRA, PDGFRB, PIK3CA, PIK3CB, PIK3CD, PIK3CG, PIK3R1, PMS2, PPP2R2A, PTCH1, PTEN, PTPN11, RAD51, RAD51B, RAD51C, RAD51D, RAD54L, RB1, RET, RICTOR, ROS1, RPS6KB1, SLX4, SMAD4, SMARCB1, SMO, SRC, STK11, TERT, TET2, TP53, TSC1, TSC2, VHL, XRCC2

AKT2, ALK, AR, ATM, BRAF, BRCA1, BRCA2, CCND1, CCND3, CCNE1, CDK4, CDK6, CHEK1, CHEK2, EGFR, ERBB2, ERBB3, ERCC1, ERCC2, ESR1, FGF1, FGF10, FGF14, FGF19, FGF2, FGF23, FGF3, FGF4, FGF5, FGF6, FGF7, FGF8, FGF9, FGFR1, FGFR2, FGFR3, FGFR4, JAK2, KIT, KRAS, LAMP1, MDM2, MDM4, MET, MYC, MYCL1, MYCN, NRAS, NRG1, PDGFRA, PDGFRB, PIK3CA, PIK3CB, PTEN, RAF1, RET, RICTOR, RPS6KB1, TFRC

AMPLIFICATION DETECTION: 59

GENE FUSION AND SPLICE VARIANT DETECTION: 55

ABL1, AKT3, ALK, AR, AXL, BCL2, BRAF, BRCA1, BRCA2, CDK4, CSF1R, EGFR, EML4, ERBB2, ERG, ESR1, ETS1, ETV1, ETV4, ETV5, EWSR1, FGFR1, FGFR2, FGFR3, FGFR4, FLI1, FLT1, FLT3, JAK2, KDR, KIF5B, KIT, KMT2A, MET, MLLT3, MSH2, MYC, NOTCH1, NOTCH2, NOTCH3, NRG1, NTRK1, NTRK2, NTRK3, PAX3, PAX7, PDGFRA, PDGFRB, PIK3CA, PPARG, RAF1, RET, ROS1, RPS6KB1, TMPRSS2


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