• Just like a chameleon utilizing its
    colored pigments and crystals to
    adapt to its surroundings,
    we proactively pioneer and adapt to
    the everchanging NGS markets with
    our cutting-edge technology to
    support our customer’s needs.

Celemics Biopharma Solutions

NGS-based Companion Diagnostics for Biopharma Companies

Overview

Companion Diagnostics (CDx) is a key technology for personalized treatment and precision medicine.

Celemics offers an NGS-based CDx development and commercialization service for
biopharma companies.
Celemics’ proprietary technologies enable comprehensive genomic profiling test with high
enough accuracy for stratification of patient cohorts and marker discovery, thereby enhancing
the efficiency and the success rate of clinical trials.
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Biopharma
Solutions

Flexible Customization Celemics offers a flexible customization service where additional genes of interest can be added to the Ready-to-Use panels, or a customized panel is newly designed
and manufactured. Prior to designing the panel, our experienced researchers and technicians engage in interactive discussion with customers especially over difficult
regions such as GC-rich or homologous regions that other companies often fail to capture.

Ready-to-Use Panels

Specification CancerScreen Core Panel CancerScreen 50 Panel
Gene Count 13 genes 54 genes
Genes APC, BRAF, EGFR, ERBB2, KRAS, MET,
NRAS, PIK3CA, SMAD4, TP53

Fusion : ALK, RET, ROS1

ABL1, AKT1, ALK, APC, ATM, BRAF, BRCA1, BRCA2, CDH1, CDK4,
CDK6, CDKN2A, CSF1R, CTNNB1, DDR2, EGFR, ERBB2, ERBB4,
ESR1, FGFR1, FGFR2, FGFR3, GNA11, GNAQ, GNAS, HRAS, IDH1,
IDH2, JAK2, KDR, KIT, KRAS, MAP2K1, MET, MLH1, MTOR, MYC,
MYCN, NOTCH1, NRAS, NTRK1, PDGFRA, PIK3CA, PTCH1, PTEN,
PTPN11, RB1, RET, ROS1, SMAD4, SMO, SRC, STK11, TP53

Fusion : ALK , RET, ROS1, NTRK1

Target size 61 kb + Rearrangement 197 kb + Rearrangement
Mutation type SNV, Indel, CNV, Rearrangement
Sample type FFPE, frozen tissue, cfDNA, RNA
Platform All sequencers from Illumina, ThermoFisher, MGI, and PacBio
Bioinformatics pipeline Primary, Secondary, and Tertiary analysis result

- FASTQ to VCF, VCF to Clinical report

End-to-End Support from Pilot Trials to Full-Scale Commercialization Our support for biopharma partners expedites the commercialization process. We help our partners to meet the quality system requirements and country-specific regulations. Our products are tested through our rigorous in-house validation system, and provided to our partners to better ensure the quality of our products and meet their goals and needs.

CancerScreen Biomarkers and FDA-Approved Anticancer Agents

CancerScreen 50 Panel CancerScreen Core Panel Biomarkers FDA-approved anticancer agents targeting the corresponding gene
ALK (Fusion) Crizotinib, Ceritinib, Alectinib, Lorlatinib
BRAF Dabrafenib+Trametinib, Vemurafenib+Cobimetinib, Encorafenib+Binimetinib
EGFR Gefitinib, Erlotinib, Afatinib, Osimertinib
ERBB2 Trastuzumab, Pertuzumab, Ado-trastuzumab, Emtansine, Neratinib
KRAS Sotorasib , Cetuximab, Panitumumab
MET Crizotinib
NRAS Cetuximab, Panitumumab
PIK3CA Alpelisib, Copanlisib, Duvelisib
RET (Fusion) Cabozantinib, Vandetanib, LOXO-292, BLU-667
ROS1 (Fusion) Crizotinib, Ceritinib, Entrectinib
FGFR3 Erdafitinib
IDH1/2 Ivosidenib, Enasidenib
NTRK1 (Fusion) Larotrectinib, Entrectinib
PDGFRA Imatinib

Performance of
Celemics Target
Enrichment
Panels

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Higher Uniformity of Celemics Panel over Company A Product. The normalized mean depth of Celemics panel (left) across the target regions shows higher uniformity
than that of company A (right). A panel with high uniformity, representing high-quality data, not only saves room for more samples in a single NGS run, but also the sequencing cost.

  • Ready-to-Use Lung Cancer Panel
    Sensitivity AF 0.5% 100%
    AF 1.0% 100%
    Specificity 100%
    Sample Amount : 20 ng DNA / Avg. Depth : 12,716.43X
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  • Custom ctDNA Panel
    Correlation between NGS and ddPCR results
    0.94
    Pearson’s ρ 0.97
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Accurate analysis of ctDNA with Celemics proprietary technologies. With the integration of molecular barcode technology, Celemics ctDNA panels have achieved 12,716x of average
depths with 100% sensitivity and specificity (left). Celemics custom ctDNA panel shows high correlation with ddPCR results, yielding Pearson’s ρ equal to 0.97 (right).

Quality System

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    ISO 3485
    The International Standard for Quality
    Management System established by
    the International Organization
    for Standardization
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    ISO 9001
    The International Standard for Quality
    Management System established by
    the International Organization
    for Standardization
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    GMP
    GMP is a system for ensuring that products
    are consistently produced and controlled
    according to quality standards

Publications

01. Circulating tumor DNA sequencing in colorectal cancer patients treated with first-line chemotherapy with anti-EGFR
Scientific Reports (2021) Lim YJ et al.; doi : https://doi.org/10.21203/rs.3.rs-411756/v1

- Clinical samples from 92 patients (blood samples)

02. Molecular Characterization of Biliary Tract Cancer Predicts Chemotherapy and PD-1/PD-L1 Blockade Responses
Hepatology (2021) Yoon JG et al.; doi: 10.1002/hep.31862. Epub ahead of print. PMID: 33884649.

- Clinical samples from 121 patients (via operation and biopsy)

03. Liquid biopsy-based tumor profiling for metastatic colorectal cancer patients with ultra-deep targeted sequencing
PLoS ONE (2020) Kang JK et al.; doi: https://doi.org/10.1371/journal.pone.0232754

- Clinical samples from 21 patients (liquid biopsy samples)

04. Development and Validation of a Next-Generation Sequencing–Based Multigene Assay to Predict the Prognosis of Estrogen
Receptor–Positive, HER2-Negative Breast Cancer
Clin Cancer Res (2020) Lee HB et al.; doi: 10.1158/1078-0432.CCR-20-2107

- Clinical samples from 413 patients (FFPE samples)

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