Celemics

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.

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

	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

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%
Sensitivity	AF 1.0%	100%
Specificity		100%
Sample Amount : 20 ng DNA / Avg. Depth : 12,716.43X

Custom ctDNA Panel
Correlation between NGS and ddPCR results
R²	0.94
Pearson’s ρ	0.97

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

ISO 13485

The International Standard for Quality
Management System established by
the International Organization
for Standardization
ISO 9001

The International Standard for Quality
Management System established by
the International Organization
for Standardization
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)

NGS-based Companion Diagnostics for Biopharma Companies

Celemics Biopharma Solutions