LiquidBiopsy LIQUIDBIOPSY. Automated Rare Template Isolation Platform

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1 LiquidBiopsy LIQUIDBIOPSY Automated Rare Template Isolation Platform

2 Enabling cancer research with highly multiplexed molecular analysis of serially collected blood samples The LiquidBiopsy Platform simplifies the isolation, enumeration, and molecular analysis of rare cells and cell-free DNA (cfdna) from whole-blood samples. Achieving high target cell recovery and exceptional purity, the platform enables downstream molecular characterization of rare cells using next-generation sequencing (NGS), FISH and IHC. Sample-to-Sequence Multi-Template Analysis: Analyze ctcdna, cfdna, and Germline DNA from a Single Blood Sample Mutation analysis has traditionally been performed only on tissue biopsy material. However, many tumors are difficult to biopsy, are accessible only using fine needle aspirates (producing little usable material), or are located either in unknown sites or in sites that are challenging and risky to access. Radiographic approaches are often insensitive to changes in tumor response, and the recovery of additional biopsy material assumes one can effectively identify the most important section of the disease for analysis. Traditional tumor assessment methods fail to capture the heterogeneity of the disease, especially during progression or resistance. The LiquidBiopsy can solve these problems. It is a supplementary blood-based biopsy mechanism that samples different parts of the disease from traditional surgical biopsy, has none of the associated side effects or risks to the patient, can be repeated as needed for effective monitoring, and samples the part of the tumor that is associated with informative metastatic events. 2 LiquidBiopsy Platform

3 The LiquidBiopsy Platform The LiquidBiopsy Platform is part of a comprehensive, cost-effective workflow for the automated isolation, enumeration, and analysis of rare cells. High CTC capture rates are critical in patient monitoring applications because there are usually less than 10 CTCs in a 7.5 ml whole blood sample (1 target cell per billion). Sample multiplexing and a one-day blood drawto-sequence workflow accelerate turnaround time for higher- throughput laboratories. The proprietary Cynvenio sheath flow chip uniquely supports patient monitoring applications. It achieves high purity while capturing CTCs using immunomagnetic positive selection. This flow chip enables low-input DNA sequencing without the need for whole-genome amplification. The chip can then be used to stain and scan the captured target cells. The LiquidBiopsy Comprehensive Sample-to-Sequence Workflow Sample Prep Automated CTC and cfdna Isolation Sequence CTCs, cfdna, and Germline Nucleic Acid Sample-to-Sequence 1-Day Workflow* Stabilize blood samples for up to 96 hours Isolate/enumerate viable CTCs & collect cfdna sample Designed to provide more results from less input DNA * Workflow based on a typical 8-hour workday. LiquidBiopsy Platform 3

4 LiquidBiopsy has everything you need for multi-template analysis (DNA & RNA) High Capture Rate Sheath Flow Chip Proprietary Cynvenio sheath flow chip technology processes the reagents for the immunomagnetic isolation of target rare cells. It s design ensures a high rate of capture of mutation-bearing cancer cells while avoiding high background, or the unwanted binding of non-target cells to the surface of the separation device which leads to unfavorable single-to-noise ratio. cfdna Isolation Module The cfdna Isolation module provides walk-away automated DNA isolation from plasma. Platform Consumables A comprehensive family of consumables is available to process whole blood samples on the LiquidBiopsy platform, including reagents, buffers, stains, elution tubes, capture antibodies and flow cells. Standard EMT enrichment kits are available Optional capture antibodies include anti-epcam, anti-her2, anti-trop2, anti-egfr, anti-psma, and others cfdna kits for automated isolation of rare cfdna from plasma Easy Blood Sample Collection LiquidBiopsy blood collection kits are designed to streamline sample collection for transport to the laboratory. The kit includes a proprietary stabilizer to maintain samples for up to 96 hours (4 days) at ambient temperature. This four day window supports global transport of samples with no cold-chain requirements. 4 LiquidBiopsy Platform

5 Optimized LiquidBiopsy worflow: blood sample to genomic data in 48 hours High-Content Imaging Purify CTC Purify cfdna Up to a 48 hour turn-around Variant detection: 0.1% to 1% sensitivity CTC enrichment: 1 in a billion cells Detects somatic & germline mutations Cynvenio Bioinformatics Platform Germline WBC NGS Analysis DNA Sequence Assembly & Mutation Variant Calling Genomic Research Reporting The LiquidBiopsy Workflow: A comprehensive and distributable workflow for ctcdna, cfdna and germline sequencing with optional CTC enumeration and highly multiplexed genomic data.

6 Performance designed to meet your needs High purity, high recovery multi-analyte isolation The LiquidBiopsy Platform s proprietary sheath flow technology eliminates the need for whole-genome amplification, a process that can introduce false positives in the data. The platform uses a proprietary antibody immunocapture protocol for automated target cell capture by positive selection. Researchers may choose to use custom antibody cocktails for blood samples containing tumor types best confirmed with tunable assays. Regardless of which antibody cocktail, the platform makes possible a high-purity capture of CTCs that supports all downstream analysis methods, from FISH to NGS. Highly multiplexed sensitivity The LiquidBiopsy Platform achieves up to 100% sensitivity down to <1% mutation frequency at 2,000x read depth and allows for multiplexing samples on the sequencer. For example, when used with the Ion S5 sequencing platform, up to 20 patient samples comprised of all three templates (ctcdna, cfdna, and Germline DNA) may be sequenced simultaneously on each run. Walk-away automation The LiquidBiopsy Platform automates flow cell priming, blood sample loading, and target cell isolation on a flow chip with the same form factor as a standard pathology slide. The system also automates the isolation of rare cfdna from plasma on the same platform. CTC Recovery and Reproducibility The LiquidBiopsy Platform facilitates identification of single cells and clusters of cells with high linearity of both recovery and purity (Figures 1 and 2). Figure 3 represents the intra-assay variability and demonstrates that there is no variation caused by the platform or the operator. This precise performance is compatible with high-content imaging and molecular analysis of CTCs. Measured cell density (cells/ml) Linearity of recovery R = Spiked cell density (cells/ml) Figure 1 Measured cell density (cells/ml) Linearity of purity R = Spiked cell density (cells/ml) Figure 2 Measured cell density (cells/ml) Intra-assay variability R = Spiked cell density (cells/ml) Figure 3 6 LiquidBiopsy Platform

7 LiquidBiopsy tunable assay architecture supports user-defined protocols The LiquidBiopsy cell enrichment platform is capable of processing a wide variety of sample inputs and supports a full suite of readout protocols for maximum analytical flexibility. The system has an open and tunable architecture that can readily be adapted to additional capture biomarkers, affinity reagents, and user defined research assays. The flexible design of the LiquidBiopsy platform supports a variety of research areas, including: Oncology Stem Cell Research Immunology Infectious Disease Endothelial Cells Fetal Cells / Noninvasive Prenatal Testing (NiPT) Peptide/Aptamer Libraries Tunable Assay Configuration INPUTS DOWNSTREAM READ-OUTS Whole Blood Sequencing Buffy Coat Dissociated Tissue PCR Ascites Urine Expression Analysis FISH/CISH IF or IHC Analysis LiquidBiopsy Platform 7

8 LiquidBiopsy Ordering Information Item Description Cat. No. LiquidBiopsy Platform Automated Rare Cell Isolation Platform, 4-Channel LBIS40 Blood Sample Collection Kit Includes a stabilization protocol for whole blood samples LBPK-10 (10mL) Allows unrefrigerated shipping of samples (96-hour window) Blood Sample Collection Kit Includes a stabilization protocol for whole blood samples LBPK-20 (20mL) Allows unrefrigerated shipping of samples (96-hour window) Reagents & Consumables Kit Sheath flow chips (isolation and staining/scanning) CYN Assay, Dry Kit (8mL Protocol) Disposable SpinElute & PCR tubes (for cell pellet recovery) and platform pipette tips & hoppers Reagents & Consumables Kit Sheath flow chips (isolation and staining/scanning) CYN Assay, Dry Kit (1mL Protocol) Disposable SpinElute & PCR tubes (for cell pellet recovery) and platform pipette tips & hoppers Reagents & Consumables Kit Reagents for the recovery and production of genomic DNA CYN Assay, Wet Kit Wash buffers Capture Antibodies EpCAM Capture Antibody Cyn Assay Her2 Capture Antibody Cyn Trop2 Capture Antibody Cyn Bi Label (Epcam + Trop2) Capture Antibodies Cyn Bi Label (Epcam + Her2) Capture Antibodies Cyn Bi Label (Her2 + Trop2) Capture Antibodies Cyn Tri Label (Epcam + her2 + Trop2) Capture Antibodies Cyn cfdna Consumables Kit cfdna isolation kit CYN cfdna Isolation Module Allows walk-away cfdna isolation on the LiquidBiopsy CYN platform using magnetic bead separation. sales@cynvenio.com Visit Call (800) The LiquidBiopsy platform is for research use only. Not for use in diagnostic procedures. The performance characteristics and safety and effectiveness have not been established and are not cleared or approved by the FDA Cynvenio Biosystems, Inc. All rights reserved. LiquidBiopsy is a registered trademark of Cynvenio Biosystems, Inc. Ion S5 is a trademark of Thermo Fisher Scientific Inc. and its subsidiaries A

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