• ALS
  • ALS

    ALS Automated Lab Solutions GmbH develops, manufactures and distributes high-quality automation solutions for life sciences in a broad range of areas including molecular diagnostics, cancer and stem cell research, cell line development and bioprocessing. The ALS CellCelector™ platform allows automated screening and recovery of single cells, clusters, spheroids and colonies for downstream molecular analysis or cell culturing. It combines fast high-resolution fluorescence imaging, sensitive cell detection technology and a patented robotics tool for automated recovery of 100% pure and intact cells. The field of liquid biopsies and namely the isolation of pure circulating tumour cells (CTCs) is one of the key application areas of the CellCelector platform. The CellCelector can be easily combined with a range of upstream processing technologies and is compatible with various downstream single cell characterization methods (e.g. NGS, RNA-Seq). Beyond a range of end-customer products ALS offers OEM development and production of customized systems from design and prototyping to serial manufacturing and quality control. ALS is privately owned and is headquartered in Jena, Germany.

    Dr. Constantin Nelep

    Marketing Director

    Otto-Eppenstein-Str. 30

    07745 Jena

    Germany

    cn@als-jena.com

    Jens Eberhardt

    Managing Director

    Otto-Eppenstein-Str. 30

    07745 Jena

    Germany

    je@als-jena.com

  • Cancer typesSolid tumors (breast, prostate, colorectal, pancreatic, ovarian, lung, brain, melanoma and others)
    Clinical applicationALS has developed and validated workflows (RUO) for identification and isolation of single circulating tumour cells (CTCs) enriched from blood of cancer-diagnosed patients. Isolated single CTCs can be used for downstream molecular analysis applications.
    Liquid Biobsy SourceBlood
    Technologies available for liquid biopsyCellCelector™ for single cell/cluster isolation
    Key publicationsNelep C, Eberhardt J. Automated rare single cell picking with the ALS CellCelector Cytometry Part A, Cytometry A 2018; 93(12):1267-1270

    Lampignano R, Yang L, Neumann M, Franken A, Fehm T, Niederacher D, Neubauer H. A novel workflow to enrich and isolate patient-matched EpCAMhigh and EpCAMlow/negative CTCs enables the comparative characterization of the PIK3CA status in metastatic breast cancer. Int J Mol Sci 2017; 18: 1885.

    Neumann M, Schneck H, Decker Y, Schoemer S, Franken A, Endris V, Pfarr N, Weichert W, Niederacher D, Fehm T, et al. Isolation and characterization of circulating tumor cells using a novel workflow combining CellSearch® and CellCelector™. Biotechnol Prog 2016; 33: 125– 132.

    Lohr J, Adalsteinsson V, Cibulskis K, Choudhury A, Rosenberg M, Cruz-Gordillo P, Francis J, Zhang C, Shalek A, Satija R et al. Whole-exome sequencing of circulating tumor cells provides a window into metastatic prostate cancer. Nat Biotechnol 2014; 32: 479– 484.

    Donato C, Szczerba B, Scheidmann M, Castro-Giner F, Aceto N. Micromanipulation of Circulating Tumor Cells for Downstream Molecular Analysis and Metastatic Potential Assessment. J. Vis. Exp. (147), e59677 (2019).
  • ANGLE
  • ANGLE

    ANGLE is a liquid biopsy company with patent protected platforms include the Parsortix® circulating tumor cell (CTC) enrichment technology and the HyCEADTM Ziplex® platform for cost effective, highly multiplexed analysis of nucleic acids and proteins. The Parsortix® system enables a liquid biopsy (a simple blood draw) to be used to provide the cells of interest to the user in a format suitable for multiple types of downstream analyses. The system is based on a microfluidic device that captures cells based on a combination of their size and compressibility. The system is epitope independent and can capture all types of CTCs as well as CTC clusters in a viable form (alive). FDA clearance is in process for the United States. ANGLE is seeking to be the first ever FDA cleared CTC harvesting system. The HyCEADTM Ziplex® platform is based on a patented flow through array technology. It provides for low cost, highly multiplexed, rapid and sensitive capture of targets from a wide variety of sample types. The system is extremely sensitive and is ideal for measuring gene expression and other markers directly from Parsortix harvests. Using the Parsortix and HyCEAD Ziplex systems, ANGLE has already undertaken two separate 200 subject clinical studies to develop an ovarian cancer pelvic mass triage test, with the results showing best in class accuracy (ROC-AUC) of 95.1%. The assay is currently in the process of a 200 patient clinical verification study.


    Lara Stevanato, PhD

    Product Support Lead

    10 Nugent rd, Surrey Research Park

    Guildford

    GU2 7AF

    United Kingdom

    L.Stevanato@angleplc.com


    Michael O’Brien

    Business Development Director

    10 Nugent rd, Surrey Research Park,

    Guildford

    GU2 7AF

    United Kingdom

    M.OBrien@angleplc.com

  • Cancer typesSolid tumor (e.g. breast, ovarian/pelvic mass, lung, prostate, melanoma, colorectal cancer)
    Clinical application“ANGLE has two (currently RUO) applications for:

    1. Harvesting circulating tumour cells (CTCs) from peripheral blood of patients diagnosed with metastatic breast cancer. Harvested CTCs can be used for subsequent downstream
    applications.

    2. Aiding the assessment of the likelihood of ovarian malignancy in women who present with a suspicious pelvic mass, prior to surgical intervention or other patient management decisions.”
    Liquid Biopsy sourceBlood
    Technologies available for Liquid BiopsyParsortix® and HyCEAD Ziplex® systems
    Articles related to the Parsortix® technologyKoch C, Joosse SA, , Schneegans S,y , Wilken OJW, Janning M, Loreth D, Müller V, Prieske K, Banys-Paluchowski M, Horst LJ, Loges S, Peine S, Wikman H, Gorges TM and Pantel K. Pre-Analytical and Analytical Variables of Label-Independent Enrichment and Automated Detection of Circulating Tumor Cells in Cancer Patients. Cancers. 2020; 12: 442.

    Reinhardt F, Franken A, Meier-Stiegen F, Driemel C, Stoecklein NH , Fischer JC, Niederacher D, Ruckhaeberle E, Fehm T, and Neubauer H. Diagnostic Leukapheresis Enables Reliable Transcriptomic Profiling of Single Circulating Tumor Cells to Characterize Inter-Cellular Heterogeneity in Terms of Endocrine Resistance. Cancers. 2019; 11: 903

    Janning M, Kobus F, Babayan A, Wikman H , Velthaus JL, Bergmann S, Schatz S, Falk M, Berger LA, Böttcher LM, Päsler S, Gorges TM, O’Flaherty L, Hille C, Joosse SA , Simon R, Tiemann M, Bokemeyer C, Reck M, Riethdorf S, Pantel K and Loges S. Determination of PD-L1 Expression in Circulating Tumor Cells of NSCLC Patients and Correlation with Response to PD-1/PD-L1 Inhibitor. Cancers. 2019; 11: 835

    Szczerba BM, Castro-Giner F, Vetter M, Krol I, Gkountela S, Landin J, Scheidmann MC, Donato C, Scherrer R, Singer J, Beisel C, Kurzeder C, Heinzelmann-Schwarz V, Rochlitz C, Weber WP, Beerenwinkel N, Aceto N. Neutrophils escort circulating tumour cells to enable cell cycle progression. Nature. 2019; 566; 553–557.

    Miller MG, Robinson PS, Wagner C, O'Shannessy DJ. The Parsortix™ Cell Separation System-A Versatile Liquid Biopsy Platform. Cytometry A. 2018; 93 (12): 1234-1239
  • Boehringer Ingelheim
  • Boehringer Ingelheim
    BC R&D

    Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good. As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of 19 billion euros. Focus on research and development (R&D) Our significant investment of almost 3.5 billion euros in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life. R&D investments in the Human Pharma business alone amounted to EUR 3 billion or 21.8% of its net sales. There are some 100 projects across all phases of the research process. The goal is for 75% of these projects to be either the first molecule in their active ingredient class or in a new therapeutic area. The focus of R&D in Human Pharma lies on cardiovascular and metabolic diseases, oncology, respiratory, immunology, diseases of the central nervous system and retinal health. The global research network for human pharmaceuticals includes facilities in Germany (Biberach), the US (Ridgefield), Austria (Vienna) and Japan (Kobe). We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

  • Dr. Jürgen Braunger

    Head of Cellular and Protein Biomarkers

    Translational Medicine & Clinical Pharmacology

    Boehringer Ingelheim Pharma GmbH & Co. KG

    juergen.braunger@boehringer-ingelheim.com



    Dr. Yarúa Jaimes

    Biomarker Lead Expert in Cellular and Protein Biomarkers

    Translational Medicine & Clinical Pharmacology

    Boehringer Ingelheim Pharma GmbH & Co. KG

    yarua.jaimes@boehringer-ingelheim.com

  • Cancer typessolid tumors (mainly NSCLC, CRC)
    Clinical applicationcharacterization of mutations, underlying disease and resistance mechanisms
    Liquid Biopsy sourceplasma for cfDNA analyses, CTCs in collaboration with UKE
    Technologies available for Liquid BiopsyNGS, ddPCR
    Key publicationsJanning M, Kobus F, Babayan A, Wikman H, Velthaus JL, Bergmann S, Schatz S, Falk M, Berger LA, Böttcher LM, Päsler S, Gorges TM, O'Flaherty L, Hille C, Joosse SA, Simon R, Tiemann M, Bokemeyer C, Reck M, Riethdorf S, Pantel K, Loges S. Determination of PD-L1 Expression in Circulating Tumor Cells of NSCLC Patients and Correlation with Response to PD-1/PD-L1 Inhibitors. Cancers (Basel). 2019 Jun 17;11(6).

    Riethdorf S, O'Flaherty L, Hille C, Pantel K. Clinical applications of the CellSearch platform in cancer patients. Adv Drug Deliv Rev. 2018 Feb 125:102-121

    O’Flaherty L, Wikman H, Pantel K. Biology and clinical significance of circulating tumor cell subpopulations in lung cancer. Tansl. Lung Canc. Res., 2017 Aug
  • Bristol Myers Squibb
  • Bristol Myers Squibb
    BMS

    Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at bms.com/de or follow us on Twitter. Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol-Myers Squibb company and Juno Therapeutics, a Bristol-Myers Squibb company.

    Dr. Martin Broekmans

    Project Manager Precision Medicine

    Arnulfstr. 29

    80636 München

    Germany

    Martin.broekmans@bms.com

    BMS

    Stefan Reininghaus

    Team Lead Precision Medicine

    Arnulfstr. 29

    80636 München

    Germany

    Stefan.reininghaus@bms.com

  • Invitek
  • Invitek
    Invitek

    InviGenius PlUS 2
    InviGenius Plus 2

    Invitek Molecular develops and commercializes tailor-made nucleic acid purification solutions that enable manual and automated DNA/RNA extraction from virtually any sample material. We provide customized development and contract manufacturing services to in-vitro diagnostics companies all over the world. With more than 20 years of experience, our solutions cover all challenges from the idea up to the realization of a marketable product according to CE-IVD. Invitek Molecular is committed to developing products for state-of-the-art nucleic acid extraction used in oncology applications. Our extraction kits for liquid biopsy and pathology enable a reliable and reproducible application of cell-free circulating DNA and genomic DNA used in NGS detection systems. With our fully automated solutions, you can automate your workflows with just short hands-on time.

  • Thomas Matthes

    CEO

    Invitek Molecular GmbH
    Robert-Rössle-Str. 10
    13125 Berlin
    Germany

    thomas.matthes@invitek-molecular.com


    Preeti Panda

    Project Manager

    Invitek Molecular GmbH
    Robert-Rössle-Str. 10
    13125 Berlin
    Germany

    preeti.panda@invitek-molecular.com

  • Cancer typessolid tumors
    Clinical applicationcirculating cell-free DNA extraction for NGS applications
    Liquid Biopsy sourceplasma, serum, urine
    Technologies available for Liquid Biopsyfully automated cell-free DNA extraction using magnetic beads on the InviGenius® PLUS platform
  • QIAGEN
  • QIAGEN

    QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. The application field of liquid biopsies is one of the key focus areas driving QIAGENs product development initiatives to provide new innovative Sample to insight solutions. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharma and biotech companies) and Academia (life sciences research). As of September 30, 2019, QIAGEN employed approximately 5,200 people in over 35 locations worldwide.

    Thorsten Singer, PhD

    Senior Director Scientific Affairs LS

    QIAGEN Strasse 1

    40724 Hilden

    Germany

    thorsten.singer@qiagen.com

    Siegfried Hauch, PhD

    Director R&D, Head of Scientific Affairs LS

    QIAGEN Strasse 1

    40724 Hilden

    Germany

    siegfried.hauch@qiagen.com

  • Cancer typesSolid tumors (e.g. breast, prostate, colon, lung cancer) and leukemia
    Tumor stem cells and tumor cells in epithelial-mesenchymal transition
    Clinical applicationResearch studies in the field of prediction of therapy stratification and success; determination of (prognostic) biomarkers
    Liquid Biobsy Sourceblood, plasma, serum, urine, CSF
    Technologies available for liquid biopsyCTC enrichment and characterization: AdnaTest product line

    Exosomes and extracellular vesicles, isolation and RNA extraction: ExoEasy / ExoRNeasy product line

    Circulating cell free nucleic acids including ctDNA and miRNA (automated and manual): QIAamp and QIAsymphony / EZ1 products; miRNeasy

    Stabilization of biospecimens (blood, tissue, saliva): PAX and RNAprotect product lines Technologies for reference material analysis (e.g. FFPE, frozen tissue)

    Comprehensive range of nucleic acid analysis technologies: digital PCR, qPCR, NGS, bioinformatics, customization (e.g. panels)

    Service: all technologies listed above
    Key publicationsWeber S, Spiegl B, Perakis SO, Ulz CM, Abuja PM, Kashofer K, Leest PV, Azpurua MA, Tamminga M, Brudzewsky D, Rothwell DG, Mohan S, Sartori A, Lampignano R, Konigshofer Y, Sprenger-Haussels M, Wikman H, Bergheim IR, Kloten V, Schuuring E, Speicher MR, Heitzer E.Technical Evaluation of Commercial Mutation Analysis Platforms and Reference Materials for Liquid Biopsy Profiling.Cancers (Basel). 2020 Jun 16;12(6):E1588

    Babayan A, Neumann MHD, Herdean A, Shaffer JM, Janning M, Kobus F, Loges S, Di Pasquale F, Kubista M, Schlumpberger M, Lampignano R, Krahn T, Schlange T, Sprenger-Haussels M, Pantel K, Kloten V.Multicenter Evaluation of Independent High-Throughput and RT-qPCR Technologies for the Development of Analytical Workflows for Circulating miRNA Analysis.Cancers (Basel). 2020 May 5;12(5):1166.

    Keup C, Storbeck M, Hauch S, Hahn P, Sprenger-Haussels M, Hoffmann O, Kimmig R, Kasimir-Bauer S. Multimodal Targeted Deep Sequencing of Circulating Tumor Cells and Matched Cell-Free DNA Provides a More Comprehensive Tool to Identify Therapeutic Targets in Metastatic BreastCancer Patients. Cancers (Basel). 2020 Apr 27;12(5):1084

    Schneegans S, Lück L, Besler K, Bluhm L, Stadler JC, Staub J, Greinert R, Volkmer B, Kubista M, Gebhardt C, Sartori A, Irwin D, Serkkola E, Af Hällström T, Lianidou E, Sprenger-Haussels M, Hussong M, Mohr P, Schneider SW, Shaffer J, Pantel K, Wikman H. Pre-analytical factors affecting the establishment of a single tube assay for multiparameter liquid biopsy detection in melanoma patients.Mol Oncol. 2020 May;14(5):1001-1015

    Lampignano R, Neumann MHD, Weber S, Kloten V, Herdean A, Voss T, Groelz D, Babayan A, Tibbesma M, Schlumpberger M, Chemi F, Rothwell DG, Wikman H, Galizzi JP, Riise Bergheim I, Russnes H, Mussolin B, Bonin S, Voigt C, Musa H, Pinzani P, Lianidou E, Brady G, Speicher MR, Pantel K, Betsou F, Schuuring E, Kubista M, Ammerlaan W, Sprenger-Haussels M, Schlange T, Heitzer E. Multicenter Evaluation of Circulating Cell-Free DNA Extraction and Downstream Analyses for the Development of Standardized (Pre)analytical Work Flows. Clin Chem. 2020: 10.1373
  • Rarecells Diagnostics
  • Rarecells Diagnostics

    Rarecells Diagnostics aims to improve today’s cancer patient care through the development of highly sensitive and specific blood tests for very early cancer detection and its real time personalized treatment. Rarecells Diagnostics’ technology opens the way to an increased understanding of circulating tumor cells (CTC) biology and of their microenvironment including all types of circulating rare cells. Rarecells Diagnostics’ proprietary disruptive, label-free, liquid biopsy technology ISET® (Isolation by SizE of Tumor cells) isolates from blood and other biological fluids intact CTC of all types of cancers with extremely high sensitivity. The Company also develops and provides protocols and workflows for cyto-molecular profiling of circulating rare cells and their AI-based diagnostic identification. Rarecells Diagnostics is a spin-off of the French Public Institutions: Université Paris Descartes, INSERM (Institut National de la Santé et de la Recherche Médicale) and AP-HP (Assistance Publique- Hôpitaux de Paris), owner of the ISET® patents. Rarecells Diagnostics has the exclusive licenses of the ISET® patents.

    Naoual Benali-Furet, PhD

    Scientific Director

    Institut Necker Enfants Malades-INEM

    156 rue de Vaugirard

    75017 Paris

    Naoual.furet@rarecells.com

    Franck Parazza, PhD

    Director Sales and Marketing

    Institut Necker Enfants Malades-INEM

    156 rue de Vaugirard

    75017 Paris

    Franck.parazza@rarecells.com

  • Cancer typesSolid tumors (e.g. breast, lung, prostate, liver, melanoma, ovarian, colorectal cancer, kidney, gastric) and major leukemia types (e.g. AML, PML)
    Clinical applicationDevelopment and implementation of highly sensitive and specific liquid biopsy tests based on CTC and CTC clusters collected by ISET from blood for:
    - very early cancer diagnosis and personalized cancer management.

    - study the tumor invasion process and prevention of the development of metastasis
    Liquid Biobsy SourceBlood and other biological fluids
    Technologies available for liquid biopsyISET® Device and associated consumables, ISET-specific workflows and protocols
    Key publicationsTamminga M. et al. Detection of Circulating Tumor Cells in the diagnostic leukapheresis product of Non-Small-Cell Lung Cancer Patients Comparing CellSearch® and ISET. Cancers, 12(4), 896 (2020)

    Ried K. et al. New Screening Test Improves Detection of Prostate Cancer Using Circulating Tumor Cells and Prostate-Specific Markers.Front. Oncol., 23 (April 2020).

    Kotsakis A. et al. CD8+ PD-1+ T-cells and PD-L1+ circulating tumor cells in chemotherapy-naïve non-small cell lung cancer: towards their clinical relevance? Therapeutic advances in medical oncology, 11, : 1 –14 (2019)

    Laget S. et al. Technical Insights into Highly Sensitive Isolation and Molecular Characterization of Fixed and Live Circulating Tumor Cells for Early Detection of Tumor Invasion. PLoS One 12, (2017).

    Ilie M. et al. “Sentinel” circulating tumor cells allow early diagnosis of lung cancer in patients with chronic obstructive pulmonary disease. PLoS One 9, e111597 (2014).
  • RareCyte
  • RareCyte
    RARECYTE

    RareCyte®, a Seattle-based life sciences company founded in 2010, provides Precision Biology™ solutions for liquid biopsy and highly multiplexed tissue imaging. Our comprehensive product portfolio supports next-generation circulating tumor cell (CTC) characterization, single cell retrieval for molecular analysis, and CTC-based companion diagnostic (CDx) development as well as deep phenotyping and spatial analysis of tissues via 21-plex fluorescence imaging and micro-region sequencing for immuno-oncology and other applications. The RareCyte platform is deployed globally by academic, industry, and pharma services laboratories.

    RareCyte enables practical deployment of CTC-based liquid biopsy with instrumentation, reagents, and consumables that provide an exquisitely sensitive, accurate, reproducible, and transparent workflow from blood collection to single-cell isolation. The RareCyte platform includes AccuCyte® Sample Preparation System, RarePlex® CTC Staining Kits and CyteFinder® Instruments. CTCs and plasma may be analyzed from the same blood collection tube. The highly validated RarePlex® CTC assays allow monitoring of CTC count and investigation of up to two biomarkers, such as ER/HER2 and ARv7/synaptophysin for breast and prostate cancer clinical research respectively. The RareCyte platform incorporates an end-to-end workflow designed for consistent results in multi-site settings common to large clinical research studies. Custom assays may be created using our Developer Kit system and companion diagnostics development is available through our pharma services program.

    Eric Kaldjian, MD

    Chief Medical Officer

    2601 Fourth Avenue

    Seattle 98121

    WA 98121

    ekaldjian@rarecyte.com

    Bryan Sullivan

    SVP Sales & Marketing

    bsullivan@rarecyte.com

    Michael Rooney

    Sales Director, Europe

    mrooney@rarecyte.com

    Joshua Nordberg

    Sr. Director of CDx and Applications

    jnordberg@rarecyte.com

  • Cancer typesEpithelial cancers, including lung, breast, prostate; hematologic malignancies (exploratory)
    Clinical applicationCTC enumeration, CTC biomarker characterization and drug target detection; single-CTC sequencing; circulating fetal cell analysis (non-invasive pre-natal testing)
    Liquid Biobsy SourceBlood, fine needle aspirate, bone marrow
    Technologies available for liquid biopsyAccuCyte® Sample Preparation System, RarePlex® Staining Kits, CyteFinder® Instruments
    BiobankCTCs on slide, plasma
    Key publicationsKamal M, Saremi S, Klotz R, et al. PIC&RUN: An integrated assay for the detection and retrieval of single viable circulating tumor cells. Sci Rep 2019; 9(17470):1-10.

    Ramirez A, Bhat R, Sahay D, et al. Circulating tumor cell investigation in breast cancer patient-derived xenograft models by automated immunofluorescence staining, image acquisition, and single cell retrieval and analysis. BMC Cancer 2019; 19 (220):1-10.

    Kaldjian, E, Ramirez A, Sun Y, et al. The RareCyte® Platform for Next-Generation Analysis of Circulating Tumor Cells. Cytometry Part A. 2018; 93A: 1220-1225.

    Vossaert L, Wang Q, Salman R, et al. Reliable detection of subchromosomal deletions and duplications using cell-based noninvasive prenatal testing. Prenat Diagn. 2018; 38(13):1069-1078.

    Blau C, Ramirez A, Blau S, et al. A distributed network for intensive longitudinal monitoring in metastatic triple-negative breast cancer. J Natl Compr Canc Netw 2016; 14(1): 8-17.
  • SAGA DIAGNOSTICS
  • SAGA DIAGNOSTICS
    SAGA DIAGNOSTIC LOGO

    SAGA Diagnostics is a is a cancer genomics company focused on precision oncology and ultrasensitive liquid biopsy monitoring of cancer patients. The company is commercializing unique technology platforms which are ultrasensitive and can measure circulating tumor DNA (ctDNA) to ~0.001% MAF, which is 100-1000-fold more sensitive and specific than competing methods. Our ultrasensitive technologies are also applicable to conventional tissue biopsies.

    SAGAsafe® is a technology platform with patented chemistry which can be run on most dPCR instrument systems. It has its prime utility in detecting and measuring point mutations and indels and can be used to stratify patients, find patients eligible for therapy, monitoring therapy response and MRD, and detection of resistance mutations. The ultrasensitivity means finding more patients earlier. SAGAsafe is currently in a CE-IVD marking process, with the aim of having a menu of clinically relevant assays available for clinical use during 2020-21.

    SAGAsign® is a method combining WGS on tumor tissue followed by monitoring ctDNA by personalized dPCR. In an automated fashion, a “fingerprint” of chromosomal rearrangements is selected and a SAGAsign fingerprint assay developed using our proprietary bioinformatics pipeline. We and others have shown chromosomal rearrangements are very stable over time. SAGAsign is ideal for determining tumor burden, monitoring therapy response, detecting MRD, and recurrence monitoring. Research programs and clinical trials benefit from the cost-effectiveness and short turnaround time and SAGAsign’s ultrasensitivity. SAGA is working with academia, hospitals, and biopharma in R&D projects and sells RUO and CE-IVD kits to laboratories.

    Lao Saal, MD PhD

    CEO

    Scheelevägen 2, MV-406

    SE-22381 Lund

    Sweden

    Lao.Saal@sagadiagnostics.com

    Åke Nilsson, MSc

    Director, Corporate and Business Development

    Scheelevägen 2, MV-406

    SE-22381 Lund

    Sweden

    Ake.Nilsson@sagadiagnostics.com

    Annina Hube, PhD

    Director, Market Access

    Scheelevägen 2, MV-406

    SE-22381 Lund

    Sweden

    Annina.Hube@sagadiagnostics.com

  • Cancer typesAll cancer types (work frequently with breast, lung, GI-tract, prostate, ovarian, melanoma, leukemia, lymphoma, etc.)
    Clinical applicationPatient stratification and companion diagnostics, therapy response monitoring, MRD, recurrence monitoring, identification of resistance mechanisms
    Liquid Biobsy SourceBlood, plasma, serum, CSF, saliva, urine or any other bodily fluid (and tissues)
    Technologies available for liquid biopsyNGS, dPCR, SAGAsafe, SAGAsign, SAGAseq (in development)
    BiobankVia collaborations (tissues, plasma, serum, buffy coat, platelets)
    Key publicationsOlsson E, Winter C, George A, Chen Y, Howlin J, Tang MH, Dahlgren M, Schulz R, Grabau D, van Westen D, Fernö M, Ingvar C, Rose C, Bendahl PO, Rydén L, Borg Å, Gruvberger-Saal SK, Jernström H, Saal LH. Serial monitoring of circulating tumor DNA in patients with primary breast cancer for detection of occult metastatic disease. EMBO Mol Med. 2015 Aug;7(8):1034-47.

    Loman N, Saal LH. The state of the art in prediction of breast cancer relapse using cell-free circulating tumor DNA liquid biopsies. Ann Transl Med. 2016 Oct;4(Suppl 1):S68.

    Chen Y, George AM, Olsson E, Saal LH. Identification and Use of Personalized Genomic Markers for Monitoring Circulating Tumor DNA. Methods Mol Biol. 2018;1768:303-322.

    Isaksson S, George AM, Jönsson M, Cirenajwis H, Jönsson P, Bendahl PO, Brunnström H, Staaf J, Saal LH, Planck M. Pre-operative plasma cell-free circulating tumor DNA and serum protein tumor markers as predictors of lung adenocarcinoma recurrence. Acta Oncol. 2019 Aug;58(8):1079-1086.

    Förnvik D, Aaltonen KE, Chen Y, George AM, Brueffer C, Rigo R, Loman N, Saal LH, Rydén L. Detection of circulating tumor cells and circulating tumor DNA before and after mammographic breast compression in a cohort of breast cancer patients scheduled for neoadjuvant treatment. Breast Cancer Res Treat. 2019 Sep;177(2):447-455.

    Staaf J, Glodzik D, Bosch A, Vallon-Christersson J, Reuterswärd C, Häkkinen J, Degasperi A, Amarante TD, Saal LH, Hegardt C, Stobart H, Ehinger A, Larsson C, Rydén L, Loman N, Malmberg M, Kvist A, Ehrencrona H, Davies HR, Borg Å, Nik-Zainal S. Whole-genome sequencing of triple-negative breast cancers in a population-based clinical study. Nat Med. 2019 Oct;25(10):1526-1533.
  • Sysmex Inostics
  • Sysmex Inostics
    Sysmex
    Sysmex

    Sysmex Inostics, a subsidiary of Sysmex Corporation, is a pioneer in liquid biopsy diagnostics, having birthed the field of circulating tumor DNA (ctDNA) testing over a decade ago. Starting with OncoBEAM™ enhanced digital PCR, today we focus on our innovative ultra-high sensitivity SafeSEQ next-generation sequencing solutions. SafeSEQ technology enables ultra-high sensitive ctDNA analysis at a threshold of 0.05% mutant allelic fraction with 95% confidence. This allows the identification and selection of “low mutant” patients and enables earlier intervention in the management of cancer patients by detecting and tracking residual disease, treatment resistance, and disease recurrence. Our well-designed tests and customizable assays support pharma partners as well as oncologists with individual solutions for their routine clinical practice and clinical trials. We have a global presence with Sysmex Inostics GmbH, in Hamburg, Germany (GCP laboratory and R&D), and Sysmex Inostics Inc., our sister CLIA Service Laboratory, located in Baltimore, MD, US, to support our main focus areas of clinical development testing services and CDx/IVD kit development as well as clinical testing in China and Japan. We are a trusted partner for leading pharmaceutical companies, advancing their efforts to bring the most effective personalized cancer therapies and solutions to global markets.

  • Dr. med. Bhuwnesh Agrawal

    President & CEO

    Falkenried 88

    20251 Hamburg

    Germany

    agrawal.bhuwnesh@sysmex-inostics.com

    Dr. Frank Holtrup

    Chief Scientific Officer

    Falkenried 88

    20251 Hamburg

    Germany

    holtrup.frank@sysmex-inostics.com

  • Cancer typesBreast, Colorectal, Lung, Melanoma, Pancreatic, Prostate, AML, Glioma and others
    Clinical applicationClinical development testing services and research testing services for: screening, prognosis, monitoring, Minimal Residual Disease (MRD) detection, therapy decision and identification of therapy relevant biomarkers
    Liquid Biopsy sourceBlood, plasma, blood cells (PBMCs, Neutrophiles etc.), other materials like urine, saliva etc. upon request
    Technologies available for Liquid BiopsySafeSEQ (high sensitive NGS), OncoBEAM (gold standard digital PCR)
    Key publicationsHunter, N.; Parsons, H.; Sherry, A.; Shinn, D.; Shin, D. H.; Cole, A.; Cragnotti, G.; Groginski, T.; Leathers, M.; Richardson, A. L.; et al. Abstract P6-10-05: TBCRC 040: Pathologic Response Evaluation and Detection in Circulating Tumor DNA (PREDICT DNA): Initial Results Piloting a Tissue-Biopsy Independent Method of Identifying and Monitoring Tumor-Specific Mutations in Early Stage Breast Cancer. Cancer Res 2020, 80 (4 Supplement), P6-10–05. https://doi.org/10.1158/1538-7445.SABCS19-P6-10-05.

    Wang, Y.; Li, L.; Cohen, J. D.; Kinde, I.; Ptak, J.; Popoli, M.; Schaefer, J.; Silliman, N.; Dobbyn, L.; Tie, J.; et al. Prognostic Potential of Circulating Tumor DNA Measurement in Postoperative Surveillance of Nonmetastatic Colorectal Cancer. JAMA Oncol 2019, 5 (8), 1118. https://doi.org/10.1001/jamaoncol.2019.0512.

    Tie, J.; Cohen, J. D.; Wang, Y.; Christie, M.; Simons, K.; Lee, M.; Wong, R.; Kosmider, S.; Ananda, S.; McKendrick, J.; et al. Circulating Tumor DNA Analyses as Markers of Recurrence Risk and Benefit of Adjuvant Therapy for Stage III Colon Cancer. JAMA Oncology 2019, 5 (12), 1710–1717. https://doi.org/10.1001/jamaoncol.2019.3616.

    Rugo, H.; Mayer, E.; Storniolo, A.; Isaacs, C.; Mayer, I.; Stearns, V.; Nanda, R.; Nangia, J.; Wabl, C.; Deluca, A.; et al. Abstract PD2-12: Palbociclib in Combination with Fulvestrant or Tamoxifen as Treatment for Hormone Receptor Positive (HR+) Metastatic Breast Cancer (MBC) with Prior Chemotherapy for Advanced Disease (TBCRC 035) A Phase II Study with Pharmacodynamics Markers. Cancer Res 2019, 79 (4 Supplement), PD2-12. https://doi.org/10.1158/1538-7445.SABCS18-PD2-12.

    Rodriguez; Córdoba; Aranda; Álvarez; Vicioso; Pérez; Hernando; Bermejo; Parreño; Lluch; et al. Detection of TP53 and PIK3CA Mutations in Circulating Tumor DNA Using Next-Generation Sequencing in the Screening Process for Early Breast Cancer Diagnosis. JCM 2019, 8 (8), 1183. https://doi.org/10.3390/jcm8081183.