Biopsy-Free Tests for Disease Diagnosis and Monitoring

NeoLAB™ for Hematologic Diseases

Cell-free DNA/RNA analysis on plasma

2 • NeoGenomics Laboratories

Cell-free circulating tumor DNA/RNA analysis on plasma to reduce the need for bone marrow biopsy procedures

NeoLAB Liquid Biopsy for Hematologic Diseases

Benefits of NeoLAB cell-free hematologic tumor analysis• Sensitive assessment of therapy effectiveness and disease progress

• Allows more frequent monitoring due to non-invasive collection method

• Removes potential for missing patchy disease in marrow collection;plasma is homogeneous

• Spares patients an invasive, uncomfortable, and expensive procedure

Test InformationNeoLAB™ cell-free plasma DNA/RNA testing for hematologic diseases provides a better testing alternative that doesn’t require bone marrow samples. Our scientists and others pioneered this work in hematologic disease over the past 10+ years, and now it is available for clinical use through a simple blood draw and routine shipping to our licensed, accredited molecular laboratory.

This line of testing is based on the principle that hematopoietic cells in bone marrow are immersed in blood. Since cancer cells have high turnover, they pour their DNA/RNA into circulation as cell-free DNA/RNA. Our new tests use proprietary methods to extract these circulating nucleic acids and analyze them using next generation sequencing and other advanced methods in order to evaluate molecular abnormalities present in hematological cancers.

Clinical Applications• Screening for diagnostic mutations in

suspected myeloid disorders to determineif bone marrow biopsy is absolutelynecessary

• Monitoring disease status andresponse to therapy

• Predicting early relapse• When bone marrow sample is inadequate

(dry tap, insufficient quantity) or unavailable• When bone marrow biopsy procedure is

contraindicated (especially with fragile andpediatric patients)

NeoGenomics Laboratories • 3

Ordering InformationSpecimen options: Peripheral blood: 2 x 6 mL EDTA tubes (total 12 mL) or 10 mL in EDTA tube

Storage and transportation: Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Ship same day as drawn whenever possible; specimens <72 hours old preferred.

Turnaround Time: 7-14 days. Varies by test.

Available NeoLAB Liquid Biopsy plasma-based testsMultiplex NeoLAB Profiles

AML Profile

ASXL1 BCOR BRAF

CEBPA CSF3R DNMT3A

ETV6 EZH2 FLT3

HRAS IDH1 IDH2

JAK2 V617F JAK2 Exon 12+14

KIT KMT2A (MLL) KRAS

NPM1 NRAS PDGFRA

PHF6 PTPN11 RUNX1

SETBP1 STAG2 TET2

TP53WT1

BTK Inhibitor Acquired Resistance Panel

BTK PLC-Gamma-2

MDS/CMML Profile

ASXL1 BCOR BCORL1 BRAF

CBL CEBPA CUX1 DNMT3A

ETV6 EZH2 FLT3 HRAS

IDH1 IDH2 JAK2 V617F JAK2 Exon 12+14

KIT KRAS NPM1 NRAS

PDGFRA PTEN PTPN11 RUNX1

SETBP1 SF3B1 SRSF2 STAG2

TET2 TP53 U2AF1 ZRSR2

Myeloid Disorders Profile

ABL1 ASXL1 ATRX BCOR BCORL1 BRAF

CALR CBL CBLB CBLC CDKN2A CEBPA

CSF3R CUX1 DNMT3A ETV6 EZH2 FBXW7

FLT3 GATA1 GATA2 GNAS HRAS IDH1

IDH2 IKZF1 JAK2 V617F JAK2 Exon 12+14 JAK3 KDM6A

KIT KRAS KMT2A(MLL) MPL MYD88 NOTCH1

NPM1 NRAS PDGFRA PHF6 PTEN PTPN11

RAD21 RUNX1 SETBP1 SF3B1 SMC1A SMC3

SRSF2 STAG2 TET2 TP53 U2AF1 WT1

ZRSR2

Single Gene NeoLABsFLT3 Mutation Analysis IDH1 Mutation AnalysisIDH2 Mutation Analysisinv(16), CBFB-MYH11 Translocation

KIT (c-KIT) Mutation AnalysisKRAS Mutation AnalysisNPM1 Mutation AnalysisNRAS Mutation Analysis

PML-RARA Translocation, t(15;17)RUNX1-RUNX1T1 (AML1-ETO) Translocation, t(8;21)

Note: These NeoLABs are provided for hematologic disease indications only. Please do not submit samples from patients with solid tumors.

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M, Bhalla K, Ot tmann O, Giles F, Albitar M. Leukemia. 2006;20(11):1989-91. 15. Hemizygous/homozygous and heterozygous JAK2 mutation detected in plasma of patients with myeloproliferative diseases: correlation

with clinical behaviour. Ma W, Kantarjian H, Verstovsek S, Jilani I, Gorre M, Giles F, Cor tes J, O’Brien S, Keating M, Albitar M. Br J Haematol. 2006;134(3):341-3.

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18. Use of plasma DNA in detection of loss of heterozygosity in patients with multiple myeloma. Ahmed M, Giles F, Joe Y, Weber DM, Jilani I, Manshouri T, Giralt S, De Lima M, Keating M, Albitar M. Eur J Haematol. 2003;71(3):174-8.

19. Bet ter detection of FLT3 internal tandem duplication using peripheral blood plasma DNA. Jilani I, Estey E, Manshuri T, Caligiuri M, Keating M, Giles F, Thomas D, Kantarjian H, Albitar M. Leukemia. 2003;17(1):114-9.

NeoGenomics Laboratories is a specialized oncology reference laboratory providing the latest technologies, testing partnership opportunities, and interactive education to the oncology and pathology communities. We offer the complete spectrum of diagnostic services in molecular testing, FISH, cytogenetics, flow cytometry, and immunohistochemistry through our nation-wide network of CAP-accredited, CLIA-certified laboratories.

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