Liquid biopsy for any solid tumor type

NeoLAB™ Solid Tumor MonitorCell-free circulating tumor DNA analysis

2 • NeoGenomics Laboratories

NeoLAB Solid Tumor Monitor Cell-free circulating tumor DNA analysisNow available, a tool to manage solid tumor disease using real-time mutation data without the risk or cost of biopsy.Minimally-invasive disease monitoring is becoming an increasingly urgent priority in precision medicine. NeoGenomics offers the NeoLAB Solid Tumor Monitor to enable patients with metastatic solid tumor cancers to avoid repeat biopsies and yet still benefit from an assessment of the current mutation profile of their tumor. This liquid biopsy test analyzes cell-free circulating tumor DNA (ctDNA) in the plasma from a small sample of peripheral blood.

Testing Indications:• Monitor therapy response and

molecular resistance

• Reveal emergence of new and potentially targetable clones

• Detect minimal residual disease

• Predict relapse

Applies to patients with: • Any type of solid tumor

• Metastatic disease

• FFPE solid tumor sample available for one-time baseline testing

Advantages of Monitoring with NeoLAB Solid Tumor • Testing assesses the current mutation profile

rather than historical data from an archived sample

• Issues of intra-and intertumor heterogeneity and sampling bias do not apply to circulating tumor DNA

• It creates opportunity for detection of low-level clones and clonal evolution

• Monitoring can be more frequent and is more flexible with a simple blood draw

• Quantitative results allow observation of trends of increase or decrease in the abnormal population

Genes Tested (48)• ABL1 • AKT1 • ALK • APC• ATM• BRAF • CDH1• CDKN2A• CSF1R• CTNNB1 • EGFR• ERBB2• ERBB4 • FBXW7• FGFR1• FGFR2

• FGFR3• FLT3• GNA11• GNAQ• GNAS• HNF1A• HRAS • IDH1• JAK2• JAK3• KDR• KIT• KRAS• MET• MLH1• MPL

• NOTCH1• NPM1• NRAS• PDGFRA • PIK3CA• PTEN • PTPN11• RB1• RET • SMAD4• SMARCB1• SMO• SRC• STK11• TP53• VHL

NeoGenomics Laboratories • 3

Testing Requirements and Process

Assay NotesA broad base of 48 high-priority gene targets is used in all Monitor tests regardless of which mutations were originally detected in the patient’s tumor. This allows detection of arising clones that may create resistance to current therapies or reveal options for additional targeted therapies. Assay sensitivity and rates of correlation between plasma and tumor markers vary by type and stage of tumor, markers analyzed, and methods used.

Applying NeoLAB Solid Tumor Monitor ResultsPositive: A trend in percentage of mutant allele frequency as increasing or decreasing over time may be observed. The trend can provide an early indication of response to therapy or clonal evolution of resistant populations that may precipitate a change in therapy. However, absolute values of mutant allele frequency in an individual Monitor result should not be taken as representative of tumor burden. Negative: Results may affirm therapy effectiveness and absence of detectable minimal residual disease. Negative results should be interpreted within the context of all available clinical information as abnormalities may be present at low levels below this assay’s detection limit.

Patient has metastatic disease at time of blood draw

Patient’s tumor has previously tested positive for mutation(s)

with one of the other solid tumor tests at NeoGenomics

SpecimenFFPE tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives. Fine needle aspirate (FNA): See website for complete details.

SpecimenPeripheral blood: 2 x 6 mL EDTA tubes (total 12 mL) or10 mL in EDTA tube.

SpecimenPeripheral blood: 2 x 6 mL EDTA tubes (total 12 mL) or10 mL in EDTA tube.

NO YES

NeoLAB™ Solid Tumor

Monitor(TAT 14 days)

NeoLAB™ Solid Tumor

Monitor(TAT 14 days)

NeoTYPE® Precision Profile

(TAT 14 days)

12701 Commonwealth Dr., Suite 9Fort Myers, FL 33913 Phone: 866.776.5907/ Fax: 239.690.4237 neogenomics.com© 2018 NeoGenomics Laboratories, Inc. All Rights Reserved. All other trademarks are the property of their respective owners.Rev. 040618

Other NeoLAB Liquid Biopsy Options• AML Profile• BTK Inhibitor Acquired Resistance Panel• MDS/CMML Profile • Myeloid Disorders Profile• EGFR T790M• FLT3 Mutation Analysis • IDH1 Mutation Analysis • IDH2 Mutation Analysis • Inv(16), CBFB-MYH11 Translocation • KIT (c-KIT) Mutation Analysis • KRAS Mutation Analysis • NPM1 Mutation Analysis • NRAS Mutation Analysis • PML-RARA Translocation, t(15;17) • Prostate – Liquid Biopsy

• RUNX1-RUNX1T1 (AML1-ETO) Translocation, t(8;21)

References1. Brock G, Castellanos-Rizaldos E, Hu L, et al. Liquid biopsy for cancer screening, patient stratification and monitoring.

Transl Cancer Res. 2015;4(3):280-290.2. Ignatiadis M, Lee M, Jeffrey SS. Circulating tumor cells and circulating tumor DNA: Challenges and opportunities on

the path to clinical utility. Clin Canc Res. 2015;21(1)4786-4800. 3. Karachaliou J, Mayo-de-las-Casas C, Molino-Vila MA, Rosell R. Real-time liquid biopsies become a reality in cancer

treatment. Ann Transl Med. 2015. 3(3):36+.4. Diaz LA, Bardelli A. Liquid biopsies: Genotyping circulating tumor DNA. J Clin Onc. 2014. 32(6):579-586.

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.

Committed to research as the means to improve patient care, we provide Pharma Services for pharmaceutical companies, in vitro diagnostic manufacturers, and academic scientist-clinicians. We promote joint publications with our client physicians. NeoGenomics welcomes your inquiries for collaborations. Please contact us for more information.